Evaluation of data quality in the Spanish EURECCA Esophagogastric Cancer Registry.

BACKGROUND: Although the number of nationwide clinical registries in upper gastrointestinal cancer is increasing, few of them perform regular clinical audits. The Spanish EURECCA Esophagogastric Cancer Registry (SEEGCR) was launched in 2013. The aim of this study was to assess the reliability of the data in terms of completeness and accuracy. METHODS: Patients who were registered (2014-2017) in the online SEEGCR and underwent esophagectomy or gastrectomy with curative intent were selected for auditing. Independent teams of surgeons visited each center between July 2018 and December 2019 and checked the reliability of data entered into the registry. Completeness was established by comparing the cases reported in the registry with those provided by the Medical Documentation Service of each center. Twenty percent of randomly selected cases per hospital were checked during on-site visits for testing the accuracy of data (27 items per patient file). Correlation between the quality of the data and the hospital volume was also assessed. RESULTS: Some 1839 patients from 19 centers were included in the registry. The mean completeness rate in the whole series was 97.8% (range 82.8-100%). For the accuracy, 462 (25.1%) cases were checked. Out of 12,312 items, 10,905 were available for verification, resulting in a perfect agreement of 95% (87.1-98.7%). There were 509 (4.7%) incorrect and 35 (0.3%) missing entries. No correlation between hospital volume and the rate of completeness and accuracy was observed. CONCLUSIONS: Our results indicate that the SEEGCR contains reliable data.

Eficacia y seguridad de la terapia de vacío endoscópica para el tratamiento de perforaciones y dehiscencias anastomóticas del tracto digestivo superior / Safety and efficacy of endoscopic vacuum therapy for the treatment of perforations and anastomotic leaks of the upper gastrointestinal tract

OBJETIVO: Evaluar la eficacia y seguridad de la terapia de vacío endoscópica (TVE) en perforaciones y dehiscencias del tracto digestivo superior. PACIENTES Y MÉTODOS: Estudio retrospectivo observacional donde se incluyeron todos los pacientes que presentaron algún defecto del tracto gastrointestinal superior y que fueron sometidos a TVE en el período comprendido entre abril de 2017 y febrero de 2019 en 3 centros españoles. Para ello se utilizó el único sistema de terapia de vacío aprobado para uso endoscópico hasta la fecha (Eso-SPONGEr; B. Braun Melsungen AG, Melsungen, Alemania). RESULTADOS: Un total de 11 pacientes fueron sometidos a TVE como tratamiento de una dehiscencia de sutura anastomótica tras esofaguectomía (n=7), gastrectomía (n=2), como tratamiento de una perforación esofágica tras septomiotomía endoscópica de Zenker (n=1) y tras una perforación esofágica espontánea o síndrome de Boerhaave (n=1). La mediana del tamaño de la cavidad fue de 8×3cm. De mediana, la TVE se inició a los 7días de la cirugía inicial. La mediana de duración de la TVE fue de 28días. La mediana de esponjas colocadas fue de 7 y el intervalo de recambio de las esponjas, de 3,7días. En 10 casos (91%) se consiguió el cierre del defecto y en 9 casos (82%) la resolución clínica del cuadro infeccioso asociado. Cinco pacientes presentaron algún evento adverso: 3 estenosis anastomóticas, un episodio de dolor retrofaríngeo y un caso de neumonía de nueva aparición. La mediana de estancia hospitalaria desde el inicio de la TVE fue de 45días. Un paciente falleció debido a complicaciones sépticas secundarias a la dehiscencia de sutura. CONCLUSIÓN: La TVE tiene una eficacia superior al 90% en las perforaciones y fugas anastomóticas del tracto digestivo superior. Adicionalmente es una terapia segura, siendo los eventos adversos leves

AIM: To evaluate the efficacy and safety of endoscopic vacuum therapy (EVT) in the management of perforations and anastomotic leaks of the upper gastrointestinal tract. PATIENTS AND METHODS: This is a retrospective observational study which included patients who underwent EVT due to any upper gastrointestinal defect between April 2017 and February 2019 in three Spanish Hospitals. To this end, we used the only medical device approved to date for endoscopic use (Eso-SPONGEr; B. Braun Melsungen AG, Melsungen, Germany). RESULTS: 11 patients were referred for EVT of an anastomotic leak after esophagectomy (n=7), gastrectomy (n=2), esophageal perforation secondary to endoscopic Zenker's septomiotomy (n=1) and Boerhaave syndrome (n=1). The median size of the cavity was 8×3cm. The median delay between surgery and EVT was 7 days. The median of EVT duration was 28 days. The median number of sponges used was 7 and the mean period replacement was 3.7 days. In 10 cases (91%), the defect was successfully closed. In 9 cases (82%) clinical resolution of the septic condition was achieved. 5 patients presented some adverse event: 3 anastomotic strictures, 1 retropharyngeal pain and 1 case of new-onset pneumonia. The median hospital stay from the start of EVT was 45 days. 1 patient died owing to septic complications secondary to the anastomotic leak. CONCLUSION: EVT was successful in over 90% of perforations and anastomotic leaks of the upper gastrointestinal tract. Moreover, this is a safe therapy with only mild adverse events associated

Safety and efficacy of endoscopic vacuum therapy for the treatment of perforations and anastomotic leaks of the upper gastrointestinal tract. / Eficacia y seguridad de la terapia de vacío endoscópica para el tratamiento de perforaciones y dehiscencias anastomóticas del tracto digestivo superior.

AIM: To evaluate the efficacy and safety of endoscopic vacuum therapy (EVT) in the management of perforations and anastomotic leaks of the upper gastrointestinal tract. PATIENTS AND METHODS: This is a retrospective observational study which included patients who underwent EVT due to any upper gastrointestinal defect between April 2017 and February 2019 in three Spanish Hospitals. To this end, we used the only medical device approved to date for endoscopic use (Eso-SPONGEr; B. Braun Melsungen AG, Melsungen, Germany). RESULTS: 11 patients were referred for EVT of an anastomotic leak after esophagectomy (n=7), gastrectomy (n=2), esophageal perforation secondary to endoscopic Zenker's septomiotomy (n=1) and Boerhaave syndrome (n=1). The median size of the cavity was 8×3cm. The median delay between surgery and EVT was 7 days. The median of EVT duration was 28 days. The median number of sponges used was 7 and the mean period replacement was 3.7 days. In 10 cases (91%), the defect was successfully closed. In 9 cases (82%) clinical resolution of the septic condition was achieved. 5 patients presented some adverse event: 3 anastomotic strictures, 1 retropharyngeal pain and 1 case of new-onset pneumonia. The median hospital stay from the start of EVT was 45 days. 1 patient died owing to septic complications secondary to the anastomotic leak. CONCLUSION: EVT was successful in over 90% of perforations and anastomotic leaks of the upper gastrointestinal tract. Moreover, this is a safe therapy with only mild adverse events associated.

A real-life analysis on the indications and prognostic relevance of perioperative chemotherapy in locally advanced resectable gastric adenocarcinoma.

BACKGROUND AND PURPOSE: Perioperative chemotherapy (periCTX) based on the "MAGIC" scheme has become a standard treatment in Europe for locally advanced oesophagogastric cancer. We assessed implementation and long-term oncological outcomes of MAGIC periCTX for locally advanced gastric cancer. METHODS: Population-based cohort study of all patients with locally advanced gastric cancer undergoing surgical resection with curative intent in Catalonia and Navarra (the first two autonomous communities included in the EURECCA Upper GI Spanish Working Group) between January 2011 and December 2013. The main variable was the percentage of patients treated with MAGIC periCTX. Kaplan-Meier analysis and Cox proportional hazards model were used to assess the survival benefit of periCTX. RESULTS: Among 814 patients, 217 (26.6%) received periCTX (especially patients more likely to receive it: aged < 70 years, with proximal tumors, low anesthetic risk, and cT3-4/cN+ clinical stage). 35% did not complete perioperative chemotherapy, with no relationship with age. PeriCTX showed no effect on postoperative morbimortality. Histological tumor regression was more often absent or poor (38.2%) than total or almost total (27.8%), although clinico-pathological lymph-node downstaging was higher than expected by staging inaccuracy (38.7% vs. 24.2%). PeriCTX was associated with a better survival only in cT3-4 and cN+ patients, showing less prognostic relevance than optimal oncological surgery with D2 lymphadenectomy. CONCLUSIONS: Only 26.6% of locally advanced resectable gastric cancer patients received PeriCTX. Pathological response was poor, although some degree of nodal downstaging was observed. Survival benefit of periCTX was limited to cT3-4 and cN+ patients, being less relevant than D2 lymphadenectomy.

Phase II trial of preoperative chemoradiotherapy with oxaliplatin, cisplatin, and 5-FU in locally advanced esophageal and gastric cancer.

BACKGROUND: Based on a phase I study showing the feasibility of combining of oxaliplatin, cisplatin, and 5-fluorouracil (5-FU) (OCF) with radiation therapy (RT) in esophageal cancer, the efficacy of this regimen in esophageal, gastroesophageal (GE), and gastric (G) cancer was assessed in this phase II multicenter study. PATIENTS AND METHODS: Patients with resectable tumors were eligible. Treatment included two cycles of oxaliplatin 85 mg/m(2), cisplatin 55 mg/m(2), and continuously infused 5-FU 3 g/m(2) in 96 h and concurrent RT (45 Gy), followed by surgery after 6-8 weeks. Primary end point was complete pathologic response (pCR). RESULTS: Forty-one patients were enrolled. Tumor location was esophagus 39% (squamous 10/adenocarcinoma 6), GE junction 32%, and stomach 29%. G3-G4 adverse events included asthenia (27%) and neutropenia (14%). One toxic death occurred. Thirty-one patients (75.6%) underwent surgery (R0 in 94%). Pathologic response was achieved in 58% of patients, with pCR in 50% and 16% of esophageal and GE/G cancer, respectively. pCR was achieved in 67% of squamous cell carcinoma. Survival: median follow-up, 50.4 months; median progression-free survival and overall survival were 23.2 and 28.4 months, respectively. CONCLUSION: Preoperative OCF plus RT showed an acceptable toxicity and promising activity especially in squamous cell esophageal cancer.

Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese subjects.

BACKGROUND: Data on the effectiveness of sleeve gastrectomy in improving or resolving type 2 diabetes mellitus (T2DM) and the metabolic syndrome (MS) are scarce. METHODS: A twelve-month prospective study on the changes in glucose homeostasis and the MS in 91 severely obese T2DM subjects undergoing laparoscopic SG (SG; n = 39) or laparoscopic Roux-en-Y gastric bypass (GBP; n = 52), matched for DM duration, type of DM treatment, and glycemic control was conducted. RESULTS: At 12 months after surgery, subjects undergoing SG and GBP lost a similar amount of weight (%EBL: SG: 63.00 +/- 2.89%, BPG: 66.06 +/- 2.34%; p = 0.413). On that evaluation, T2DM had resolved, respectively, in 33 out of 39 (84.6%) and 44 out of 52 (84.6%) subjects after SG and GBP (p = 0.618). The rate of resolution of the MS (SG: 62.2%, BPG: 67.3%; p = 0.392) was also comparable. A shorter DM duration (p < 0.05), a DM treatment not including pharmacological agents (p < 0.05), and a better glycemic control (p < 0.05), were significantly associated with T2DM resolution in both surgical groups. Weight loss was not associated with T2DM resolution after SG or GBP, but was associated with resolution of the MS following the two surgical procedures (p < 0.05). CONCLUSIONS: Our data show that at 12 months after surgery, SG is as effective as GBP in inducing remission of T2DM and the MS. Furthermore, our data suggest that SG and GBP represent a successful an integrated strategy for the management of the different cardiovascular risk components of the MS in subjects with T2DM.

Laparoscopic-assisted approach in rectal cancer patients: lessons learned from >200 patients.

BACKGROUND: The applicability of laparoscopic surgery in the treatment of colorectal diseases is still controversial. Early reports on laparoscopic-assisted colectomy in patients with colon cancer suggested that it minimizes surgical trauma, decreases perioperative complications, and leads to a more rapid recovery. To our knowledge, no previous studies have compared the laparoscopic vs the open approach in rectal cancer. The aim of this paper was to assess the results of laparoscopic techniques in patients with rectal cancer. METHODS: From March 1998 to February 2003, all patients admitted to our unit with adenocarcinoma of the rectum were evaluated for surgery by the laparoscopic approach. RESULTS: A total of 220 patients with a mean age of 67.3 years were included in the study. One hundred thirty patients (59%) were treated with neoadjuvant chemoradiotherapy. In >75% of the patients, a surgical procedure with sphincter preservation was performed. The rate of conversion to the open approach was 20%. Ten patients had intraoperative complications. Fifty-eight patients (26.3%) developed postoperative complications. The length of hospital stay was 6.8 days. The distribution of tumor stages was as follows: stage I, 16.81%; stage II, 33.6%; stage III, 26.36%; stage IV, 19.09%. The mean number of lymph nodes was 13.8. The incidence of local relapse was 5.3%, with a follow-up of 18 months. CONCLUSION: Laparoscopic surgery can be safely performed in patients with adenocarcinoma of the rectum with good short-term results. Randomized controlled trials are needed to confirm these results.

Acute phase response in laparoscopic and open colectomy in colon cancer: randomized study.

PURPOSE: All types of trauma to the organism produce a systemic response that is proportional to the severity of the lesion caused. The more rapid clinical recovery during the postoperative period of patients undergoing laparoscopic-assisted colectomy vs. patients receiving conventional surgery suggests that laparoscopic surgery produces less surgical trauma. The aim of this randomized, prospective study was to compare acute phase postoperative response in patients diagnosed with colon neoplasm undergoing open segmentary colectomy vs. laparoscopic-assisted colectomy. METHODS: From June 1994 to July 1997 the results of 97 patients (58 submitted to open colectomy and 39 undergoing laparoscopic-assisted colectomy) were analyzed. Blood determinations of cortisol, prolactin, C-reactive protein and interleukin-6 were performed before surgery and at 4, 12, 24, and 72 hours after surgery. RESULTS: The plasma levels of cortisol and prolactin were higher in the postoperative period with both surgical techniques with no significant differences being observed. The levels of interleukin-6 achieved a maximum peak at 4 hours after surgery, later showing a decrease and practically achieving basal levels at 72 hours in both groups. The levels of interleukin-6 were higher with significant differences at 4, 12, and 24 hours in the patients undergoing open colectomy. The plasma levels of C-reactive protein were significantly lower at 72 hours in patients receiving laparoscopic-assisted colectomy. CONCLUSIONS: The results obtained in this randomized, prospective study suggest that acute phase systemic response is attenuated in patients undergoing laparoscopic-assisted colectomy in comparison with patients receiving open colectomy.

Could age be an indication for laparoscopic colectomy in colorectal cancer?

BACKGROUND: The incidence of colorectal carcinoma increases in the elderly. Regardless of age as an isolated factor, postoperative complications represent the main factor in increasing hospital mortality. METHODS: The aim of this study was to compare the short-term results (first 30 postoperative days) after laparoscopically assisted colectomy (LAC) and open segmental colectomy (OC) in colorectal carcinoma between two groups of patients, older than 70 and younger than 70 years of age. In the study from November 1993 to June 1998, 255 patients were evaluated to participate. RESULTS: Peristalsis, oral intake, and discharge from the hospital occurred earlier in LAC than in OC treated patients, in the two age groups. The mean operative time was significantly longer in the LAC than in the OC patients in the two age groups. No differences were observed in morbidity between LAC and OC in the group younger than 70 years of age. However, the overall morbidity was significantly lower in the LAC group in patients older than 70 years. One patient in the LAC group older than 70 years died. CONCLUSION: These results suggest that laparoscopically assisted colectomy may be particularly indicated in elderly patients.