Effects of neoadjuvant chemotherapy for patients with obstructive colon cancer: A multicenter propensity score-matched analysis (YCOG2101).

Aim: Obstructive colon cancer is locally advanced colon cancer with poor prognosis. However, the effect of neoadjuvant chemotherapy (NAC) on obstructive colon cancer remains unclear. Therefore, this study aimed to investigate the safety and efficacy of NAC in patients with obstructive colon cancer. Methods: From January 2012 to December 2017, we collected patient data for clinical stage II/III obstructive colon cancer at seven Yokohama Clinical Oncology Group (YCOG) institutions. The long-term outcomes of the NAC and non-NAC groups were analyzed retrospectively after adjusting for patients' background characteristics using propensity score matching. Results: Among the 202 eligible patients, propensity score matching extracted 51 patients each for the NAC and non-NAC groups. After matching, the groups showed no marked differences in the background factors. All the patients in the NAC group underwent diverting stoma construction. Nineteen patients (37.3%) experienced grade 3-4 adverse events during NAC. The incidence of postoperative complications was similar between groups. The 5-year progression-free survival rates were 75.8% in the NAC group and 63.0% in the non-NAC group (p = 0.22, log-rank test). The 5-year overall survival rates were 88.5% in the NAC group and 78.8% in the non-NAC group (p = 0.09, log-rank test). Conclusion: Although NAC was feasible for obstructive colon cancer after diverting stoma construction, its effects on long-term outcomes could not be proven.

Multicenter randomized phase II study on S-1 and oxaliplatin therapy as an adjuvant after hepatectomy for colorectal liver metastases (YCOG1001).

PURPOSE: The high recurrence rate of colorectal cancer liver metastasis (CRCLM) after surgery remains a crucial problem. However, adjuvant chemotherapy after hepatectomy for CRCLM has not yet been established. This study evaluated the efficacy of adjuvant therapy with S-1 and oxaliplatin (SOX). METHODS: In a multicenter, randomized, phase II study, patients undergoing curative resection of CRCLM were randomly enrolled in a 1:1 ratio to either the low- or high-dose group. S-1 and oxaliplatin were administered from days 1 to 14 of a 3-week cycle as a 2-h infusion every 3 weeks. The dose of S-1 was fixed at 80 mg/m2. The doses in the low- and high-dose oxaliplatin groups were 100 mg/m2 (low-dose group) and 130 mg/m2 (high-dose group), respectively. This treatment was repeated eight times. The primary endpoint was the rate of discontinuation owing to toxicity. The secondary endpoints were the relapse-free survival (RFS) and frequency of adverse events (AEs). RESULTS: Between August 2010 and March 2015, 44 patients (low-dose group: 31 patients and high-dose group: 13 patients) were enrolled in the study. Of these, one patient was excluded from the efficacy analysis. In the high-dose group, five of nine patients were unable to continue the study due to toxicity in February 2013. At that time, recruitment to the high-dose group was stopped from the protocol. The relative dose intensity (RDI) for S-1 in the low- and high-dose groups were 49.8 and 48.7% (p = 0.712), and that for oxaliplatin was 75.9 and 73.0% (p = 0.528), respectively. The rates of discontinuation due to toxicity were 60 and 53.8% in the low- and high-dose groups, respectively, with no marked difference noted between the groups (p = 0.747). The frequency of grade ≥ 3 common adverse events was neutropenia (23.3%/23.1%), diarrhea (13.3%/15.4%), and peripheral sensory neuropathy (6.7%/7.7%). The disease-free survival (DFS) at 3 years was 52.9% in the low-dose group, which was not significantly different from that in the high-dose group (46.2%; p = 0.705). CONCLUSIONS: SOX regimens as adjuvant therapy after hepatectomy for CRCLM had high rates of discontinuation due to toxicity in both groups. In particular, the RDI of S-1 was < 50%. Therefore, the SOX regimen is not recommended as adjuvant chemotherapy after hepatectomy for CRCLM.

Short-term and Mid-term Outcomes of Indocyanine Green Fluorescence Imaging-Guided Laparoscopic Right-Sided Colectomy: A Propensity Score-Matched Cohort Study.

BACKGROUND: With the use of indocyanine green fluorescence imaging, intraoperative lymphatic flow assessment is possible. However, no report has indicated mid-term outcomes of indocyanine green fluorescence imaging-guided laparoscopic right-sided colectomy. OBJECTIVE: To analyze the mid-term outcomes of indocyanine green fluorescence imaging-guided laparoscopic right-sided colectomy. DESIGN: This was a retrospective, multi-institutional study that used propensity score matching. SETTINGS: We conducted this study within the framework of the Yokohama Clinical Oncology Group in Japan. PATIENTS: A total of 921 patients who underwent laparoscopic right-sided colectomy with lymph node dissection for colon cancer with clinical stages I to III between January 2009 and December 2020 were included. The patients were divided into 2 groups: 233 patients who underwent the lymphatic flow evaluation (indocyanine green group) and 688 patients who did not undergo lymphatic flow evaluation (non-indocyanine green group). MAIN OUTCOMES MEASURES: The 3-year relapse-free survival after laparoscopic right-sided colectomy with and without indocyanine green fluorescence imaging were compared. RESULTS: After propensity score matching, 231 patients were matched in each group. The numbers of dissected central lymph nodes (6 vs 4, p < 0.001), intermediate lymph nodes (7 vs 6, p = 0.03), and the total number of dissected lymph nodes (31 vs 27, p = 0.047) were significantly higher in the indocyanine green group. The median follow-up was 36.9 months. The estimated respective 3-year relapse-free survival and overall survival rates were 88.8% and 94.5% in the indocyanine green group and 89.4% and 94.7% in the non-indocyanine green group ( p = 0.721 and 0.300), respectively, with no difference between the 2 groups. LIMITATIONS: Retrospective design of the study. CONCLUSIONS: Indocyanine green fluorescence imaging-guided laparoscopic right-sided colectomy could increase the number of total, intermediate, and central lymph nodes. However, there was no difference in mid-term outcomes. See Video Abstract. RESULTADOS A CORTO Y MEDIO PLAZO DE LA COLECTOMA LAPAROSCPICA DEL LADO DERECHO GUIADA POR IMGENES DE FLUORESCENCIA CON VERDE DE INDOCIANINA UN ESTUDIO DE COHORTE EMPAREJADO POR PUNTAJE DE PROPENSIN: ANTECEDENTES:Con el uso de imágenes de fluorescencia verde de indocianina, es posible la evaluación del flujo linfático intraoperatorio. Sin embargo, no hay ningún reporte que indique los resultados a medio plazo de la colectomía laparoscópica del lado derecho guiada por imágenes de fluorescencia con verde de indocianina.OBJETIVO:Examinar los resultados a mediano plazo de la colectomía laparoscópica del lado derecho guiada por imágenes de fluorescencia con verde de indocianina.DISEÑO:Estudio multiinstitucional retrospectivo con emparejamiento de puntuación de propensión.CONFIGURACIÓN:Realizado en el marco del Grupo de Oncología Clínica de Yokohama en Japón.PACIENTES:Un total de 921 pacientes sometidos a colectomía laparoscópica del lado derecho con disección de ganglios linfáticos por cáncer de colon con estadio clínico I a III entre enero de 2009 y diciembre de 2020. Los pacientes se dividieron en dos grupos: 233 pacientes sometidos a la evaluación del flujo linfático (grupo con verde de indocianina) y 688 pacientes que no sometidos a la evaluación del flujo linfático (grupo sin verde de indocianina).PRINCIPALES MEDIDAS DE RESULTADOS:Se comparó la supervivencia libre de recaídas a los 3 años después de la colectomía laparoscópica del lado derecho con y sin imágenes de fluorescencia con verde de indocianina.RESULTADOS:Después de emparejar el puntaje de propensión, 231 pacientes fueron emparejados en cada grupo. El número de ganglios linfáticos centrales disecados (6 frente a 4, p < 0,001) y de ganglios linfáticos intermedios (7 frente a 6, p = 0,03) y el número total de ganglios linfáticos disecados (31 frente a 27, p = 0,047) fueron significativamente mayor en el grupo verde de indocianina. La mediana de seguimiento fue de 36,9 meses. Las tasas respectivas estimadas de supervivencia libre de recaídas y supervivencia general a los 3 años fueron del 88,8 % y el 94,5 % en el grupo con verde de indocianina y del 89,4 % y el 94,7 % en el grupo sin verde de indocianina ( p = 0,721 y 0,300), sin diferencias entre los dos grupos.LIMITACIONES:Estudio de diseño retrospectivo.CONCLUSIONES:La colectomía laparoscópica del lado derecho guiada por imágenes de fluorescencia con verde de indocianina puede aumentar el número de ganglios linfáticos totales, intermedios y centrales. Sin embargo, no hubo diferencias en los resultados a medio plazo. (Traducción-Dr. Fidel Ruiz Healy ).

Exploratory randomized phase II trial for optimizing treatment dosage and duration of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer: YCOG1402 (SOAP trial).

Introduction: Conventionally, the recommended duration of adjuvant chemotherapy of colon cancer had been 6 months. The IDEA Collaboration suggested that shortening capecitabin and oxaliplatin (CAPOX) adjuvant chemotherapy may be possible. S-1 and oxaliplatin (SOX) treatment is standard treatment in metastatic colorectal cancer in Japan. The aim of this study was to optimize treatment dosage and duration of adjuvant SOX in stage III colon cancer. Methods: This trial was as open-label multi-center randomized phase II study. Patients with stage III colon cancer were randomly assigned to 3 months or 6 months of adjuvant SOX treatment in different doses: 130 mg/m2 (3 months) or 100 mg/m2 (6 months) of oxaliplatin. The primary endpoint was 3-year disease-free survival (DFS) and the null hypothesis for the primary endpoint was that the 3-year DFS was ≤72% in each arm and was tested with a one-sided significance level of 10%. Results: Eighty-two patients were assigned to the 6 months arm and 81 to the 3 months arm. The 3-year DFS was 75.0% (80% CI 67.95-80.72, p = 0.282) in the 6 months arm and 76.9% (80% CI 70.1-82.38, p = 0.171) in the 3 months arm. Treatment completion rate and relative dose intensity (RDI) were higher in 3 months than 6 months arm. The adverse events (AE) were similar in both arms. Conclusions: The 3-year DFS was not significantly superior to null hypothesis in both 3 months and 6 months arms for the stage III colon cancer. Primary endpoint was not achieved. The SOX regimen was not feasible in long-term outcomes.

Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial.

OBJECTIVE: The aim of the present randomized controlled trial was to evaluate the superiority of indocyanine green fluorescence imaging (ICG-FI) in reducing the rate of anastomotic leakage in minimally invasive rectal cancer surgery. BACKGROUND: The role of ICG-FI in anastomotic leakage in minimally invasive rectal cancer surgery is controversial according to the published literature. METHODS: This randomized, open-label, phase 3, trial was performed at 41 hospitals in Japan. Patients with clinically stage 0-III rectal carcinoma less than 12 cm from the anal verge, scheduled for minimally invasive sphincter-preserving surgery were preoperatively randomly assigned to receive a blood flow evaluation by ICG-FI (ICG+ group) or no blood flow evaluation by ICG-FI (ICG- group). The primary endpoint was the anastomotic leakage rate (grade A+B+C, expected reduction rate of 6%) analyzed in the modified intention-to-treat population. RESULTS: Between December 2018 and February 2021, a total of 850 patients were enrolled and randomized. After the exclusion of 11 patients, 839 were subject to the modified intention-to-treat population (422 in the ICG+ group and 417 in the ICG- group). The rate of anastomotic leakage (grade A+B+C) was significantly lower in the ICG+ group (7.6%) than in the ICG- group (11.8%) (relative risk, 0.645; 95% confidence interval 0.422-0.987; P =0.041). The rate of anastomotic leakage (grade B+C) was 4.7% in the ICG+ group and 8.2% in the ICG- group ( P =0.044), and the respective reoperation rates were 0.5% and 2.4% ( P =0.021). CONCLUSIONS: Although the actual reduction rate of anastomotic leakage in the ICG+ group was lower than the expected reduction rate and ICG-FI was not superior to white light, ICG-FI significantly reduced the anastomotic leakage rate by 4.2%.

A multicenter cohort study on mapping of lymph node metastasis for splenic flexural colon cancer.

Aim: There have been no reports of searching for metastases to lymph nodes along the accessory middle colic artery (aMCA). The aim of this study was to investigate the metastasis rate of the aMCA for splenic flexural colon cancer. Methods: Patients with histologically proven colon carcinoma located in the splenic flexure, clinically diagnosed as stage I-III were eligible for this study. Patients were retrospectively and prospectively enrolled. The primary endpoint was frequency of lymph node metastasis to the aMCA (station 222-acc and 223-acc). The secondary endpoint was the frequency of lymph node metastasis to the middle colic artery (MCA) (station 222-lt and 223) and left colic artery (LCA) (station 232 and 253). Results: Between January 2013 and February 2021, a total of 153 consecutive patients were enrolled. The location of the tumor was 58% in the transverse colon and 42% in the descending colon. Lymph node metastases were observed in 49 cases (32%). The presence of aMCA rate was 41.8% (64 cases). The metastasis rates of stations 221, 222-lt, and 223 were 20.0%, 1.6%, and 0%, and stations 231, 232, and 253 were 21.4%, 1.0%, and 0%, respectively. The metastasis rates of stations 222-acc and 223-acc were 6.3% (95% confidence interval: 1.7%-15.2%) and 3.7% (95% confidence interval: 0.1%-19%), respectively. Conclusions: This study identified the distribution of lymph node metastases from splenic flexural colon cancer. If the aMCA is present, this vessel should be targeted for dissection, taking into account the frequency of lymph node metastasis.

Randomized controlled trial evaluating the effect of the use of a laparoscopic lens-cleaning device during laparoscopic colorectal surgery on the multidimensional workload (YCOG1903).

BACKGROUND: OpClear® is a newly developed laparoscopic lens-cleaning device that can be attached to a laparoscope. The present study determined whether or not the use of a OpClear® reduces the multidimensional surgery-specific workload of the operator during laparoscopic colorectal surgery for colorectal cancer compared with the reference technique (warm saline) by a randomized controlled trial. METHODS: Patients diagnosed with colorectal cancer and scheduled for laparoscopic colorectal surgery were randomly allocated to the warm saline arm or Opclear® arm. The primary endpoint was the multidimensional workload of the first operator (value of SURG-TLX). The secondary endpoints were the operative time and total number of lens washes outside the abdominal cavity. RESULTS: Between March 2020 and January 2021, a total of 120 patients were enrolled in this study. A total of 4 patients were excluded from the full analysis set. A total of 116 patients (warm saline arm: 59 patients, Opclear® arm: 57 patients) were therefore analyzed. The baseline factors were well-balanced between the two arms. Regarding SURG-TLX, there was no significant difference in the overall workload between the two arms. Operators in the Opclear® arm required significantly less physical demand than in the warm saline arm (Opclear® arm: 6, warm saline arm: 7; p = 0.046). The operative time was similar between the two arms. The total number of lens washes outside the abdominal cavity in the Opclear® arm was significantly lower than that in the warm saline arm (Opclear® arm: 2, warm saline arm: 10; p < 0.001). CONCLUSIONS: There was no significant difference in the overall workload, but the physical demand and total number of lens washes outside the abdominal cavity were significantly lower in the Opclear® arm than in the warm saline arm. The use of this device may thus help reduce operator stress in terms of physical demand. The study was registered with the Japanese Clinical Trials Registry as UMIN0000038677.

[A Case of Juvenile AFP-Producing Gastric Cancer with Virchow Lymph Node Metastasis Achieved Long-Term Survival with Multimodal Therapy].

A 25-year-old male received palliative total gastrectomy plus D1 dissection plus Roux-en-Y reconstruction for hemorrhagic gastric cancer with left Virchow lymph node metastasis in 2013. The final diagnosis was Type 2, pT4a(se), pap>tub2 >hepatoid adenocarcinoma, pN3b, sM1, fStage Ⅳ. Because AFP was as high as 11,000 ng/mL, he was diagnosed with AFP-producing gastric cancer and started S-1 plus CDDP therapy. Left adrenal gland metastasis and #106pre, #16b1int lymph node metastasis were observed after 9 courses, and the therapy was changed to irinotecan plus CDDP therapy. After 17 courses, the patient was diagnosed with CR, and the drug was discontinued. Recurrence of the left adrenal gland and an increase in AFP were confirmed by CT after 8 months of suspension, and the drug was resumed. After 8 courses of resumption, PET-CT showed mediastinal and #16b1lat lymph node metastasis and changed to weekly PTX plus Ram therapy. After 2 courses, enlargement of lymph nodes and elevation of AFP was observed, and CapeOX therapy was changed. Diagnosis of left adrenal metastasis recurrence by PET-CT after 21 courses. Nivolumab was used, and radiotherapy(total 39 Gy)was performed locally. After the continuation of nivolumab for 3 years, no findings of recurrent metastasis were observed on imaging, and it was judged as CR, and nivolumab was terminated. As of June 2023, he is alive without recurrence. AFP-producing gastric cancer in the young is rare, and no cases with Virchow metastasis or para-aortic lymph node metastasis have been reported. We report a case of long-term survival in which CR was obtained with combined modality therapy.

[A Rare Case of Primary Splenic Malignant Lymphoma Associated with Esophagogastric Junction Neuroendocrine Carcinoma(NEC)].

A 75-year-old man was showed wall thickening just below esophagogastric junction(EGJ)by gastroscopy(GS). Biopsy indicated mucinous carcinoma. He was referred to our hospital. Computed tomography(CT), PET-CT showed EGJ cancer and splenic tumor. EGJ cancer was diagnosed GE, Siewert Type Ⅱ, GrePostAnt, Type 1, cT2, cN0, cM0, cStage Ⅰ. The patient underwent total gastrectomy, lower esophagectomy, D2+ #19, 20, 110, 111, 112 lymph nodes dissection, Rou-en- Y reconstruction, distal pancreatectomy, splenectomy, cholecystectomy, and enterostomy. Postoperative complication was pancreatic fistula(Grade Ⅱ). Pathological diagnosis was esophagogastric junction cancer, neuroendocrine carcinoma(NEC), GE, Siewert Type Ⅱ, GrePostAnt, Type 1, pT2(MP), pN1, pM0, pStage ⅡA. Splenic tumor was diagnosed splenic malignant lymphoma, large B-cell, diffuse(DLBCL), NOS, low-immediate risk. Patient was discharged 15 days after the operation and underwent adjuvant chemotherapy with S-1. In this case, he started taking S-1 because the prognosis of NEC is poorer than PSML. There was no evidence of recurrence after 5 months from gastrectomy. As a result of searching for"neuroendocrine tumor"and"malignant lymphoma"in the JAMAS, there was no report of NEC associated with malignant lymphoma. We experienced the rare case of primary splenic malignant lymphoma associated with EGJ NEC. In the case of gastric cancer with splenic tumor, malignant lymphoma of spleen should be concerned.

The prognostic significance of apical lymph node metastasis in patients with high-risk stage III colon cancer.

The effect of apical lymph node (APN) metastasis on the prognosis of colon cancer is unknown. The present study investigated the impact of APN metastasis on the prognosis of the patients with high-risk stage III colon cancer. This retrospective multi-institutional study included patients with pathological high-risk stage III colon cancer who underwent surgery between April 2009 and December 2014. Clinicopathological factors were examined by univariate and multivariate analyses to clarify independent risk factors for overall survival (OS) and relapse-free survival (RFS). A total of 185 patients were collected. The 5-year OS rates of patients with and without APN metastasis were 35.0% and 72.1%, respectively (p = 0.0014). The 5-year RFS rates of patients with and without APN metastasis was 16.2% and 57.2%, respectively (p = 0.0002). The rate of distant metastasis in patients with APN metastasis was significantly higher than that in patients without APN metastasis (68.8% vs. 36.7%, p = 0.012). The univariate analysis revealed that the differentiation, lymph node ratio, and APN metastasis were significantly associated with 5-year OS, and the preoperative CEA and CA19-9 levels and APN metastasis were significantly associated with 5-year RFS. The multivariate analysis showed that APN metastasis was an independent risk factor for 5-year OS and RFS. APN metastasis may be independently associated with the prognosis of patients with high-risk Stage III colon cancer.

A Prospective, Single-arm, Multicenter Trial of Diverting Stoma Followed by Neoadjuvant Chemotherapy Using mFOLFOX6 for Obstructive Colon Cancer: YCOG 1305 (PROBE Study).

OBJECTIVE: We conducted the first prospective clinical trial of neoadjuvant chemotherapy for patients with obstructive colon cancer. BACKGROUND: Obstructive colorectal cancer is locally advanced colorectal cancer with a poor prognosis. The effect of neoadjuvant chemotherapy for obstructive colon cancer is unclear. METHODS: We conducted a single arm, multicenter trial involving patients from the Yokohama Clinical Oncology Group with obstructive colon cancer. All eligible patients underwent diverting stoma formation before neoadjuvant chemotherapy. Patient received 6 cycles of mFOLFOX6 followed by primary tumor surgery and then 6 cycles of adjuvant chemotherapy. The primary endpoint was the objective response rate of all intended neoadjuvant therapy. The study was registered with the Japanese Clinical Trials Registry as UMIN000013198. RESULTS: Between April 2014, and July 2016, 50 patients were registered, and 46 received neoadjuvant chemotherapy. The objective response rate as the primary endpoint was 67.4%. The most common grade >3 adverse event associated with neoadjuvant chemotherapy was neutropenia (28.3%). Forty-five patients underwent surgical resection of the primary lesion (R0 resection in all cases). Grade >2 surgery-related complications occurred in 7 patients (15.6%). The downstaging rate was 48.9%, and the moderate or greater regression rate was 52.2%; no cases showed pathological complete response. Adjuvant chemotherapy with mFOLFOX6 was performed in 34 patients (75.6%). The 3-year relapse-free and overall survival rates were 76.5% and 95.4%, respectively. CONCLUSION: Neoadjuvant chemotherapy using mFOLFOX6 was feasible and might be a treatment option for patients with obstructive colon cancer. Further large-scale studies are warranted to confirm the present findings.

Relationship between stromal regulatory T cells and the response to neoadjuvant chemotherapy for locally advanced rectal cancer.

BACKGROUND: In addition to the direct power of anticancer drugs, the effectiveness of anticancer therapy depends on the host immune function. The present study investigated whether or not the reduction rate and histological response of preoperative chemotherapy were related to the immune microenvironment surrounding a primary tumor of the rectum. METHODS: Sixty-five patients received preoperative chemotherapy followed by resection from 2012 to 2014; all of these patients were retrospectively analyzed. CD3, CD8, and FoxP3 were immunohistochemically examined as markers for T lymphocytes, cytotoxic T lymphocytes, and regulatory T lymphocytes (Treg), respectively. The correlation between the tumor-infiltrating lymphocyte composition and the tumor reduction rate and histological response to neoadjuvant chemotherapy was investigated. RESULTS: The average tumor reduction rate was 41.5% ± 18.8%. According to RECIST, 47 patients (72.3%) achieved a partial response (PR), and 1 patient (1.5%) achieved a complete response (CR). Eight patients (12.3%) showed a grade 2 histological response, and 2 (3.1%) showed a grade 3 response. A multivariate analysis demonstrated that a low Treg infiltration in stromal cell areas was significantly associated with the achievement of a PR or CR [odds ratio (OR) 7.69; 95% confidence interval (CI) 1.96-33.33; p < 0.01] and a histological grade 2 or 3 response (OR 11.11; 95% CI 1.37-98.04; p = 0.02). CONCLUSION: A low Treg infiltration in the stromal cell areas may be a marker of a good response to neoadjuvant chemotherapy in patients with locally advanced rectal cancer.

Near-Infrared Imaging Using Indocyanine Green for Laparoscopic Lateral Pelvic Lymph Node Dissection for Clinical Stage II/III Middle-Lower Rectal Cancer: A Propensity Score-Matched Cohort Study.

BACKGROUND: The examination of the efficacy of near-infrared imaging using indocyanine green in laparoscopic lateral pelvic lymph node dissection remains insufficient. OBJECTIVE: The aim of this study was to examine whether near-infrared imaging contributed to an increase in the total number of harvested lateral pelvic lymph nodes in laparoscopic lateral pelvic lymph node dissection. DESIGN: This was a retrospective, multi-institutional study with propensity score matching. SETTINGS: We conducted this study within the framework of the Yokohama Clinical Oncology Group in Japan. PATIENTS: The study population included consecutive patients with middle-low rectal cancer (clinical stage II to III) who underwent laparoscopic lateral pelvic lymph node dissection between January 2013 and February 2018. MAIN OUTCOME MEASURES: The total number of harvested lateral pelvic lymph nodes was compared in laparoscopic lateral pelvic lymph node dissection with and without near-infrared imaging. RESULTS: A total of 172 eligible patients were included; 84 of these patients underwent laparoscopic surgery with near-infrared imaging. After propensity score matching, 58 patients were matched in each of the near-infrared and the non-near-infrared groups. The operation time in the near-infrared group was significantly longer than that in the non-near-infrared group (426 vs 369 min), and the amount of intraoperative blood loss in the near-infrared group was significantly smaller than that in the non-near-infrared group (13 vs 110 mL). The total number of harvested lateral pelvic lymph nodes in the near-infrared group was significantly higher than that in the non-near-infrared group (14 vs 9). There were no significant differences in the postoperative complication rates of the 2 groups. LIMITATIONS: The limitations of the present study include its retrospective design. CONCLUSIONS: This study revealed that laparoscopic lateral pelvic lymph node dissection combined with near-infrared imaging could increase the total number of harvested lateral pelvic lymph nodes without impairing functional preservation. See Video Abstract at http://links.lww.com/DCR/B800.This study was registered with the Japanese Clinical Trials Registry as UMIN000041372 (http://www.umin.ac.jp/ctr/index.htm).IMÁGENES CASI-INFRARROJAS UTILIZANDO VERDE DE INDOCIANINA EN LA DISECCIÓN LAPAROSCÓPICA DE GANGLIOS LINFÁTICOS PÉLVICOS LATERALES EN CASOS DE CÁNCER DE RECTO MEDIO-INFERIOR DE ESTADIO CLÍNICO II / III: ESTUDIO DE COHORTES CON PUNTUACIÓN DE PROPENSIÓNANTECEDENTES:El examen de la eficacia de las imágenes casi-infrarrojas utilizando le verde de indocianina en la disección laparoscópica de los ganglios linfáticos pélvicos laterales sigue siendo insuficiente.OBJETIVO:El objetivo de este estudio fue examinar si las imágenes casi-infrarrojas contribuyeron a un aumento en el número total de ganglios linfáticos pélvicos laterales recolectados durante su disección laparoscópica.DISEÑO:Estudio retrospectivo, multi-institucional con emparejamiento por puntuación de propensión.AJUSTES:Estudio realizado dentro el marco establecido por el Grupo de Oncología Clínica de Yokohama, Japón.PACIENTES:La población estudiada incluyó pacientes consecutivos con cáncer de recto medio-bajo (estadio clínico II a III) que se sometieron a una disección laparoscópica de los ganglios linfáticos pélvicos laterales entre enero de 2013 y febrero de 2018.PRINCIPALES RESULTADOS MEDIDAS:El número total de ganglios linfáticos pélvicos laterales extraídos se comparó en la disección laparoscópica de ganglios linfáticos pélvicos laterales con y sin imágenes casi-infrarrojas.RESULTADOS:Se incluyeron un total de 172 pacientes elegibles; 84 de estos pacientes se sometieron a cirugía laparoscópica con imágenes casi-infrarrojas. Después del emparejamiento por puntuación de propensión, 58 pacientes fueron emparejados en cada uno de los grupos de luz casi-infrarroja y los sin luz. El tiempo de operación en el grupo de luz casi-infrarroja fue significativamente más largo que en el grupo sin luz (426 frente a 369 min), y la cantidad de pérdida de sangre intraoperatoria en el grupo de luz casi-infrarroja fue significativamente menor que en el grupo sin luz (13 frente a 110 ml). El número total de ganglios linfáticos pélvicos laterales recolectados en el grupo de luz casi-infrarroja fue significativamente mayor que en el grupo sin luz (14 frente a 9). No hubo diferencias significativas en las tasas de complicaciones posoperatorias de los dos grupos.LIMITACIONES:Las limitaciones del presente estudio incluyen su diseño retrospectivo.CONCLUSIONES:Este estudio reveló que la disección laparoscópica de los ganglios linfáticos pélvicos laterales combinada con imágenes casi-infrarrojas podría aumentar el número total de ganglios linfáticos pélvicos laterales recolectados sin afectar la preservación funcional. Consulte Video Resumen en http://links.lww.com/DCR/B800. (Traducción-Dr. Xavier Delgadillo)Este estudio se registró en el Registro de Ensayos Clínicos de Japón como UMIN000041372 (http://www.umin.ac.jp/ctr/index.htm).

[A Case of Laparoscopic Total Gastrectomy for Juvenile Polyposis of Stomach with Synchronous Multiple Intramucosal Carcinomas].

The patient was a 57-year-old woman. She was referred to our hospital because severe anemia. Upper gastrointestinal endoscopy revealed polyposis throughout the stomach and lobulated polyps in cardia, greater curve of middle body of the stomach, and angulus. Colonoscopy and small bowel endoscopy showed no obvious abnormal findings. Based on these findings, a laparoscopic total gastrectomy with D1 lymph node dissection was performed for suspected juvenile polyposis of stomach with severe anemia. The gross examination of the resection specimen revealed diffuse polyposis throughout the stomach, and histopathological examination revealed hyperplasia of the orbital epithelium throughout the stomach and lack of edema in lamina propria of mucous and eosinophil leukocytic infiltration, leading to the diagnosis of juvenile polyposis of stomach. Two well differentiated adenocarcinomas were found in 2 locations, which remained within the mucosa. We report a case of laparoscopic total gastrectomy for juvenile polyposis of the stomach with gastric cancer, with some discussion of the literature.

Use of near-infrared imaging using indocyanine green associates with the lower incidence of postoperative complications for intestinal and mesenteric injury.

Anastomotic leakage after intestinal resection is one of the most serious complications of surgical intervention for hollow viscus injury. Adequate vascular perfusion of the anastomotic site is essential to prevent anastomotic leakage. Near-infrared imaging using indocyanine green (NIR-ICG) is useful for the objective assessment of vascular perfusion. The aim of this study was to evaluate the association of NIR-ICG with intestinal and mesenteric injuries. This was a retrospective, single-center study of patients undergoing surgery for intestinal and mesenteric injuries. NIR-ICG was used to evaluate vascular perfusion. Postoperative complications were assessed between NIR-ICG and non-NIR-ICG groups.The use of NIR-ICG was associated with a lower incidence of Clavien-Dindo grade ≥ III complications with a statistical tendency (p = 0.076). When limited to patients that underwent intestinal resection, the use of NIR-ICG was significantly associated with a lower risk of perioperative complications (p = 0.009). The use of NIR-ICG tended to associate with the lower incidence of postoperative complications after intestinal and mesenteric trauma surgery. NIR-ICG was associated with a significantly lower risk of complications in patients undergoing intestinal resection. The NIR-ICG procedure is simple and quick and is expected to be useful for intestinal and mesenteric trauma.

Study protocol: a multicenter randomized controlled trial of the multifaceted workload reduction of the anti-adhesion barrier for diverting ileostomy in laparoscopic rectal surgery, YCOG 2005 (ADOBARRIER study).

BACKGROUND: There are few randomized controlled trials on the efficacy of spray-type anti-adhesion material during diverting ileostomy in laparoscopic rectal cancer surgery. PURPOSE: This study will assess whether or not spraying an anti-adhesion material during diverting ileostomy could reduce the surgeon's multifaceted workload in ileostomy closure. METHODS: Patients with laparoscopic or robotic surgery for rectal cancer scheduled for low anterior resection and diverting ileostomy will be enrolled in the ADOBARRIER study (multicenter, single-blind, randomized controlled trial). The target sample size is set at 120 cases, which will be randomly divided into an anti-adhesion material-using group and a non-using group at a ratio of 1:1. The primary endpoint is the multifaceted workload of the surgeon of ileostomy closure using SURG-TLX between groups with and without usage of the anti-adhesion material during diverting ileostomy construction; the secondly endpoint is the operative time, amount of intraoperative blood loss, degree of adhesions, and extent of intra-abdominal adhesions when the ileostomy is closed. CONCLUSIONS: This RCT will evaluate the efficacy and safety of spray-type anti-adhesion material for diverting ileostomy construction. The results of this study are expected to facilitate decision-making regarding the use of anti-adhesion material. TRIAL REGISTRATION: This trial was registered with the Japan Registry of Clinical Trials (jRCT) in October 2020 as jRCTs032200155.

Identification of Patients with Locally Advanced Rectal Cancer in Whom Preoperative Radiotherapy Can Be Omitted: A Multicenter Retrospective Study at Yokohama Clinical Oncology Group (YCOG1307).

OBJECTIVES: The present study aimed to identify patients with locally advanced rectal cancer in whom preoperative radiotherapy (RT) can be omitted. METHODS: This study was a retrospective multi-institutional study for patients with pathological stage II and III rectal cancer who underwent surgery without preoperative therapy between January 2008 and December 2012. Clinicopathological factors were examined by univariate and multivariate analyses to clarify independent risk factors of local recurrence (LR). RESULTS: The 5-year cumulative local recurrence rate (LRR) of 815 patients was 11.2%. Independent predictive factors of LR were determined by a multivariate analysis to be a tumor location of <10 cm from the anal verge, a tumor diameter of ≥50 mm, undifferentiated histological type, and advanced T-N substage (T3N+ or T4Nany). In lower rectal cancer located <10 cm from the anal verge (n = 510), the 5-year cumulative LRR of patients without any remaining three factors was 4.4%, with one factor was 13.0%, with two factors was 22.2%, and with all three factors was 41.6%. CONCLUSIONS: Preoperative RT may be omitted in patients with lower rectal cancer with no risk factors. However, in addition to the present risk factors, we need to further examine the extramural vascular invasion (EMVI) status and circumferential resection margin (CRM) using magnetic resonance imaging (MRI) findings. The trial was registered with UMIN Clinical Trails Registry, number 000006039.

Evaluating the Effect of Intraoperative Near-Infrared Observation on Anastomotic Leakage After Stapled Side-to-Side Anastomosis in Colon Cancer Surgery Using Propensity Score Matching.

BACKGROUND: Recent studies have clarified that near-infrared observation using indocyanine green has the advantage of evaluating perfusion of the anastomotic site, especially in rectal cancer surgery, resulting in a reduction in anastomotic leak. OBJECTIVE: The aim of this study was to evaluate the efficacy of near-infrared observation for reducing the anastomotic leak after stapled side-to-side anastomosis in colon cancer surgery. DESIGN: This was a retrospective propensity score case-matched study. SETTINGS: The study was conducted at 3 institutions in the Yokohama Clinical Oncology Group. PATIENTS: From January 2011 to December 2019, patients who underwent colon cancer surgery with stapled side-to-side anastomosis were included. MAIN OUTCOME MEASURES: The main outcome was the percentage of anastomotic leak within 30 days after surgery. RESULTS: A total of 1034 patients were collected. There were 532 patients who underwent near-infrared observation and 502 who did not. A total of 370 patients were matched to the near-infrared and non-near-infrared groups. In the near-infrared group, 12 patients (3.2%) were judged to have poor perfusion (4 patients) and no perfusion (8 patients), so the planned transection point was changed. There were no cases of anastomotic leak among these 12 patients. The anastomotic leak rates were 3.5% (13/370) in the non-near-infrared group and 0.8% (3/370) in the near-infrared group. The anastomotic leak and reoperation rates were significantly lower in the near-infrared group than in the non-near-infrared group (OR, 0.224; 95% CI, 0.063-0.794, p = 0.001; OR, 0.348; 95% CI, 0.124-0.977, p = 0.036). LIMITATIONS: Although we reduced selection bias by performing propensity score matching, this was a retrospective study and was not randomized. CONCLUSION: This large-scale case-matched study showed that assessing perfusion by near-infrared observation significantly reduced the anastomotic leak and reoperation rates after stapled side-to-side anastomosis in colon cancer surgery and may be better suited to colo-colonic anastomosis. Video Abstract at http://links.lww.com/DCR/B513.Japanese Clinical Trials Registry: UMIN-CTR000039977. EVALUACIN DEL EFECTO DE LA OBSERVACIN INTRAOPERATORIA CON INFRARROJO CERCANO SOBRE LA FUGA ANASTOMTICA DESPUS DE UNA ANASTOMOSIS LATEROLATERAL CON ENGRAPADORA EN LA CIRUGA DE CNCER DE COLON MEDIANTE EL EMPAREJAMIENTO POR PUNTAJES DE PROPENSIN: ANTECEDENTES:Estudios recientes han aclarado que la observación con infrarrojo cercano con verde de indocianina tiene la ventaja de evaluar la perfusión del sitio anastomótico, especialmente en la cirugía de cáncer de recto, lo que resulta en una reducción de la fuga anastomótica.OBJETIVO:El objetivo de este estudio fue evaluar la eficacia de la observación con infrarrojo cercano para reducir la fuga anastomótica después de una anastomosis latero-lateral con engrapadora en la cirugía de cáncer de colon.DISEÑO:Este fue un estudio retrospectivo emparejado con puntaje de propensión.AJUSTE:El estudio se llevó a cabo en tres instituciones del Grupo de Oncología Clínica de Yokohama.PACIENTES:Desde enero de 2011 hasta diciembre de 2019, se incluyeron pacientes que se sometieron a cirugía de cáncer de colon con anastomosis latero-lateral con engrapadora.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal fue el porcentaje de fuga anastomótica dentro de los 30 días posteriores a la cirugía.RESULTADOS:Se recogió un total de 1034 pacientes. Hubo 532 pacientes que se sometieron a observación con infrarrojo cercano y 502 que no. Un total de 370 pacientes fueron emparejados con los grupos de infrarrojo cercano y no infrarrojo cercano. En el grupo de infrarrojo cercano, se consideró que 12 casos (3,2%) tenían mala perfusión (4 casos) y ninguna perfusión (8 casos), por lo que se cambió el punto de transección planificado. No hubo casos de fuga anastomótica entre estos 12 casos. Las tasas de fuga anastomótica fueron del 3,5% (13/370) en el grupo sin infrarrojo cercano y del 0,8% (3/370) en el grupo con infrarrojo cercano. Las tasas de fuga anastomótica y de reintervención fueron significativamente menores en el grupo con infrarrojo cercano que en el grupo sin infrarrojo cercano (razón de posibilidades 0,224, intervalo de confianza del 95% 0,063-0,794, p = 0,001; razón de posibilidades 0,348, intervalo de confianza del 95% 0,124 -0,977, p = 0,036, respectivamente).LIMITACIONES:Aunque se redujo el sesgo de selección al realizar el emparejamiento por puntaje de propensión, este fue un estudio retrospectivo y no fue aleatorio.CONCLUSIÓN:Este estudio de casos emparejados a gran escala demostró que la evaluación de la perfusión mediante la observación con infrarrojo cercano redujo significativamente la fuga anastomótica y las tasas de reintervención después de la anastomosis latero-lateral con engrapadora en la cirugía de cáncer de colon y puede ser más adecuada para la anastomosis colo-colónica. Consulte Video Resumen en http://links.lww.com/DCR/B513.Registro japonés de ensayos clínicos: UMIN-CTR000039977.