Long-Term Sustainability of Peri-Operative Infection Control Practices: Implementation of "Clean Cut," a Checklist-Based Quality Improvement Program in India.

Introduction: Surgical site infections (SSIs) are a substantial healthcare burden in low- and middle- income countries. "Clean Cut" is a checklist-based infection prevention and control (IPC) program intended to improve compliance to peri-operative IPC standards. We aim to study the short-term and long-term impact of its implementation in a tertiary care cancer referral center. Methods: This was a single institute, prospective interventional study. Patients undergoing elective head-neck surgical procedures were included. The "Clean Cut" program consisting of surveillance, audits, and IPC training was implemented for 6 months, after which there was no active oversight. Post-intervention (T2) and 1-year follow-up (T3) data regarding compliance to core IPC practices and SSI rates were compared with baseline (T1). Results: One hundred eighty six patients were included with 50 (26.9%), 86 (46.2%), and 50 (26.9%) patients at T1, T2, and T3, respectively. At baseline, teams complied with a mean of 3.56 of the six critical components of infection control processes which rose to 4.66 (p < 0.001) at T2, but decreased to 4.02 at T3 (p = 0.053). The SSI rate at baseline decreased significantly after Clean Cut implementation [16 (32%) vs. 12 (13.95%), p = 0.012], but returned to baseline levels after 1 year [17 (34%), p = 0.006]. Conclusion: Implementation of the "Clean Cut" program increases compliance to infection control processes and reduces SSI rates in the short term. Without continuing oversight, these rates return to baseline values after 1 year.

Impact of post-hepatectomy biliary leaks on long-term survival in different liver tumors: A single institute experience.

Backgrounds/Aims: A postoperative biliary leak is one of the most morbid complications occurring after a liver resection, the long-term impact of which remains unknown. Methods: Retrospective analysis of consecutive liver resections performed from 1 January 2011 to 31 December 2021. Primary endpoint of disease-free survival (DFS) was compared between patients with and without a bile leak, stratifying for tumor type. Survival curves were plotted using Kaplan-Meier estimates, and differences between them were analyzed using the log-rank test. Results: In toto, 862 patients were analyzed, and included 306 (35.5%) hepatocellular carcinomas, 212 (24.6%) metastatic colorectal cancers, and 111 (12.9%) cholangiocarcinomas (69 intrahepatic cholangiocarcinomas, 42 hilar cholangiocarcinomas). Occurrence of a bile leak was associated with significantly poorer DFS only in patients with cholangiocarcinoma (median DFS 9.9 months vs. 24.9 months, p = 0.013), and further analysis was restricted to this cohort. A Cox regression performed for factors associated with DFS detriment in patients with cholangiocarcinoma showed that apart from node positivity (hazard ratio [HR]: 2.482, p = 0.033) and margin positivity (HR: 2.65, p = 0.021), development of a bile leak was independently associated with worsening DFS on both univariate and multiple regression analyses (HR: 1.896, p = 0.033). Conclusions: Post-hepatectomy biliary leaks are associated with significantly poorer DFS only in patients with cholangiocarcinoma, but not in patients with hepatocellular carcinoma or metastatic colorectal cancer. Methods to mitigate this survival detriment need to be explored.

Comparison of age-stratified survival outcomes of gallbladder cancers in an Indian population.

BACKGROUND: Gallbladder cancers (GBCs) occur a decade earlier in India in comparison to the global occurrence, limiting the applicability of existing literature on age adjusted outcomes. METHODS: Patients who underwent surgery between 01.01.2010 and 31.12.2020 for GBC were analyzed. Patients were divided into three age groups: group 1(≤40 years), group 2(41-60 years), group 3(>60 years) and their outcomes were compared. RESULTS: Total of 6190 patients were treated for suspected or diagnosed GBC with a median age of 57 years. Curative resection was performed in 749 (67.9%) patients, of whom 114 (16.2%), 471 (62.9%), and 164 (21.9%) patients were in groups 1, 2, and 3, respectively. 5-year disease-free survival (DFS) [46.8% vs. 58.5%, p = 0.031] and overall survival (OS)[53.5% vs. 66.6%, p = 0.05] of group 3 were significantly lower than group 1. Patient age (HR 1.021), AJCC stage (HR 6.413), pathologic residual disease in the gallbladder fossa (HR 2.44), and extranodal tumor deposits (HR 1.762) were identified as independent predictors of poor OS. CONCLUSIONS: Gallbladder cancers in the Indian population show poorer outcomes with advancing age. Higher proportion of males in the elderly group with a more advanced stage at presentation are plausible reasons for poorer outcomes.

Factors Predicting Prognosis in Metastatic Grade 1 Gastro-entero-pancreatic Neuroendocrine Tumors.

INTRODUCTION: The incidence of gastroenteropancreatic neuroendocrine tumors (GEP-NET) has steadily increased. These tumors are considered relatively indolent even when metastatic. What determines survival outcomes in such situations is understudied. MATERIALS AND METHODS: Retrospective analysis of a prospectively maintained NET clinic database, to include patients of metastatic grade 1 GEP-NET, from January 2018 to December 2021, to assess factors affecting progression-free survival (PFS). RESULTS: Of the 589 patients of GEP-NET treated during the study period, 100 were grade 1, with radiological evidence of distant metastasis. The median age was 50 years, with 67% being men. Of these, 15 patients were observed, while 85 patients received treatment in the form of surgery (n = 32), peptide receptor radionuclide therapy (n = 50), octreotide LAR (n = 22), and/or chemotherapy (n = 4), either as a single modality or multi-modality treatment. The median (PFS) was 54.5 months. The estimated 3-year PFS and 3-year overall survival rates were 72.3% (SE 0.048) and 93.4% (SE 0.026), respectively. On Cox regression, a high liver tumor burden was the only independent predictor of PFS (OR 3.443, p = 0.014). The 5-year OS of patients with concomitant extra-hepatic disease was significantly lower than that of patients with liver-limited disease (70.7% vs. 100%, p = 0.017). CONCLUSION: A higher burden of liver disease is associated with shorter PFS in patients with metastatic grade I GEP-NETs. The OS is significantly lower in patients with associated extrahepatic involvement. These parameters may justify a more aggressive treatment approach in metastatic grade 1 GEP-NETs.

Outcomes of incidental versus non-incidental T2 gallbladder cancer: A single-institute experience of 425 cases.

BACKGROUND: Up to 60% of incidentally detected gallbladder cancers (GBCs) have a primary stage of pathologic T2 stage (pT2), defined by invasion of the peri-adventitial tissue by the tumour, a plane breached during a simple cholecystectomy. This study assesses the impact of incidental detection of pT2 GBCs on survival outcomes. METHODS: Retrospective analysis of pT2 GBCs undergoing a curative resection was performed. Patients who received neoadjuvant chemotherapy before an upfront radical resection were excluded. Outcomes of patients undergoing upfront surgery (uGBC) and incidentally detected tumours (iGBC) were compared. RESULTS: From a total of 1356 patients, 425 patients with pT2 GBCs were included. Of these, 118 (27.7%) and 307 (72.23%) patients were in the uGBC and iGBC groups, respectively. Patients with iGBC had significantly higher locoregional, (62 [19.8%] vs. 11 [9.3%]; p = 0.009), liver, (36 [11.5%] vs. 4 [3.4%]; p = 0.01), and abdominal wall recurrences (23 [7.4%] vs. 1 [0.8%]; p = 0.009). Five-year disease free survival rates were 68.7% and 49.2% in the uGBC and iGBC groups, respectively (p = 0.013). Five-year overall survival rates were 71.7% and 64.6% in the uGBC and iGBC groups, respectively (p = 0.317). CONCLUSIONS: Incidentally detected pT2 GBCs have significantly poorer outcomes compared to similarly staged patients undergoing an upfront radical cholecystectomy.

Big data and RCT's in surgical oncology: Impact on improving hepatopancreatobiliary cancer surgical care on the global stage.

Randomized controlled clinical trials (RCTs) are at the heart of "evidence-based" medicine. Conducting well-designed RCTs for surgical procedures is often challenged by inadequate recruitment accrual, blinding, or standardization of the surgical procedure, as well as lack of funding and evolution of the treatment strategy during the many years over which such trials are conducted. In addition, most clinical trials are performed in academic high-volume centers with highly selected patients, which may not necessarily reflect a "real-world" practice setting. Large databases provide easy and inexpensive access to data on a large and diverse patient population at a variety of treatment centers. Furthermore, large database studies provide the opportunity to answer questions that would be impossible or very arduous to answer using RCTs, including questions regarding health policy efficacy, trends in surgical practice, access to health care, the impact of hospital volume, and adherence to practice guidelines, as well as research questions regarding rare disease, infrequent surgical outcomes, and specific subpopulations. Prospective data registries may also allow for quality benchmarking and auditing. There are several high-quality RCTs providing evidence to support current practices in hepatopancreatobiliary (HPB) oncology. Evidence from big data bridges the gap in several instances where RCTs are lacking. In this article, we review the evidence from RCTs and big data in HPB oncology identify the existing lacunae, and discuss the future directions of research in HPB oncology.

Oncologic Liver Resections in a Geriatric Population: Peri-operative, Long-Term and Quality-of-Life Outcomes-Experience from a High-Volume Centre in India.

BACKGROUND: Elderly patients can often be overlooked as candidates for a major hepatic resection, by virtue of their age. To enable better patient selection for hepatic resections in this age group, we analysed the outcomes of liver resections in elderly patients to identify any potential prognostic factors. METHODS: We conducted a retrospective review of a prospectively maintained database of hepatic resections from 1 January 2010 to 31 October 2021 and analysed the post-operative outcomes in patients aged 65 years or older. Short-term outcomes were analysed in terms of length of hospital stay, 90-day major morbidity, and 90-day mortality. Long-term outcome was defined by the disease-free survival, overall survival and quality of life. RESULTS: Over a period of 11 years, 170 elderly patients underwent oncologic liver resections, of which 68 (40%) underwent a major hepatectomy. The overall morbidity and mortality rates were 32.8% and 5.3%, respectively. Extent of hepatic resection, increasing age, concomitant resection of other organs and a biliary-enteric anastomosis were independent predictors for poor immediate post-operative outcomes. Median disease-free survival and overall survival were 30 months and 78 months, respectively. The global health status was excellent in majority of patients with a mean score of 88.62. CONCLUSION: Major oncologic liver resections can be performed in well-selected geriatric population with acceptable peri-operative, long-term and quality-of-life outcomes.

Post-hepatectomy biliary leaks: analysis of risk factors and development of a simplified predictive scoring system.

PURPOSE: Most studies identifying risk factors for post-hepatectomy biliary leaks (PHBLs) have relatively small proportions of major hepatectomies. A simplified predictive score to identify high risk patients is necessary in order to investigate the efficacy of mitigation strategies. METHODS: A retrospective analysis of a prospectively maintained database of liver resections from a high-volume cancer center was performed. Multivariate regression was utilized for identification of risk factors and development of the predictive score. RESULTS: A total of 862 patients underwent a curative hepatic resection over 10 years, of whom 146 (16.9%) developed a biliary leak; 85 (9.86%), 52 (6.03%), and 9 (1.04%) patients had a grade A, B, and C leak respectively. A biliary-enteric anastomosis [OR 5.1 (95% CI 2.45-10.58); p < 0.001], a central [OR 4.33 (95% CI 1.25-14.95); p = 0.021] or an extended hepatectomy [OR 4.29 (95% CI 1.52-12.12); p = 0.006], liver steatosis [OR 2.28 (95% CI 1.09-4.77); p = 0.027], and blood loss of ≥ 2000 mL [OR 2.219 (95% CI 1.15-4.27); p = 0.017] were identified as independent predictors of a clinically significant biliary leak and were assigned 1 point each to develop the biliary leak score. Clinically significant biliary leaks were seen in 11 (2.79%), 20 (6.38%), 19 (15.4%), 9 (56.3%), and 1 (100%) patients with scores of 0, 1, 2, 3, and 4 respectively (p < 0.001). CONCLUSION: A biliary-enteric anastomosis, a central or extended hepatectomy, liver steatosis, and blood loss ≥ 2L combined result in a simple predictive score for clinically significant biliary leaks.

Role of Peri-operative Chemotherapy in Stage II (pT2N0) Gallbladder Cancers.

BACKGROUND: Evidence for adjuvant chemotherapy in gallbladder cancer (GBC) is conflicting, with a postulated beneficial effect reported in T2 stage or higher, and node-positive tumours. This study aims to assess the survival benefit of peri-operative chemotherapy in stage II (pT2N0) GBCs. METHODS: A retrospective analysis of stage II GBCs who underwent curative surgical resection was done. Patients receiving neo-adjuvant therapy (NACT) prior to resection of the gallbladder primary were excluded. Primary endpoint was disease-free survival, and outcomes of patients who received chemotherapy were compared to those who did not. Survival curves were plotted using a Kaplan-Meier analysis and difference between the survival curves was analysed using a log-rank test. RESULTS: Two hundred seventy-six patients of stage II GBC were included, of whom 188 (68.1%) received chemotherapy and 88 (31.8%) did not. Forty-one (21.8%) patients received chemotherapy in the neo-adjuvant setting. There was no significant difference in the survival of patients who did and did not receive chemotherapy (5-year DFS 67.8% vs 66%, p = 0.795). There was no significant difference in the survival of patients who received chemotherapy in the adjuvant or neo-adjuvant setting (5-year DFS 66.4% vs 71.8%, p = 0.541). There was no statistically significant difference in the survival of patients with high-risk histologic features and who did and did not receive chemotherapy (3-year DFS 72.4% vs 56%; p = 0.379). CONCLUSIONS: Routine use of chemotherapy, either in the adjuvant or neo-adjuvant setting, offers no survival advantage in stage II (pT2N0) gallbladder cancers.

Simultaneous resection of synchronous colorectal liver metastasis: Feasibility and development of a prediction model.

Backgrounds/Aims: Timing of resection for synchronous colorectal liver metastasis (CRLM) has been debated for decades. The aim of the present study was to assess the feasibility of simultaneous resection of CRLM in terms of major complications and develop a prediction model for safe resections. Methods: A retrospective single-center study of synchronous, resectable CRLM, operated between 2013 and 2021 was conducted. Upper limit of 95% confidence interval (CI) of major complications (≥ grade IIIA) was set at 40% as the safety threshold. Logistic regression was used to determine predictors of morbidity. Prediction model was internally validated by bootstrap estimates, Harrell's C-index, and correlation of predicted and observed estimates. Results: Ninety-two patients were operated. Of them, 41.3% had rectal cancers. Major hepatectomy (≥ 4 segments) was performed for 25 patients (27.2%). Major complications occurred in 20 patients (21.7%, 95% CI: 13.8%-31.5%). Predictors of complications were the presence of comorbidities and major hepatectomy (area under the ROC curve: 0.692). Unacceptable level of morbidity (≥ 40%) was encountered in patients with comorbidities who underwent major hepatectomy. Conclusions: Simultaneous bowel and CRLM resection appear to be safe. However, caution should be exercised when combining major liver resections with bowel resection in patients with comorbid conditions.

Evaluation of perioperative routine coagulation testing versus thromboelastography for major liver resection - A single-arm, prospective, interventional trial (PORTAL trial).

Background and Aims: The International Normalised Ratio (INR), which assesses the loss of procoagulant factors in the extrinsic pathway, fails to evaluate the coagulation abnormalities comprehensively after a major liver resection, which often leads to reduced synthesis of procoagulant and anticoagulant-factors. This study was conducted with an aim to study the trend and compare the results of routine coagulation tests and thromboelastography (TEG) during the perioperative period in patients undergoing major liver resections (≥3 segments). Methods: Twenty-five patients who underwent a major liver resection were enrolled. This prospective, single-arm, interventional study was performed with the primary objective of determining the serial changes in conventional coagulation tests and TEG during the perioperative period in patients undergoing major liver resections, at the preincision period, intraoperative period, postoperatively, at 48 h and on the fifth postoperative day. Transfusion requirements of blood components were also assessed with a TEG-guided replacement strategy. Spearman rank-order correlation was used to study the relationships of coagulation tests (both TEG and conventional tests) at each time point. Results: The prothrombin time (PT)-INR was elevated in 14 patients (56%) at the intraoperative, immediate postoperative and 48-h time points in contrast to the TEG parameters, which remained normal in all patients. Blood component transfusion was avoided in 4, 11 and 10 patients at the intraoperative, immediate postoperative and 48-h time points, respectively. Conclusion: International Normalised Ratio overestimates the coagulopathy in patients undergoing major liver resection, and a thromboelastography-guided transfusion strategy reduces overall transfusion requirements.

Role of prophylactic HIPEC in non-metastatic, serosa-invasive gastric cancer: a literature review.

The role of prophylactic hyperthermic intraperitoneal chemotherapy (p-HIPEC) in serosa invasive gastric cancers without gross or microscopic peritoneal disease, to reduce the rate of peritoneal relapse is an area of ongoing research. Although p-HIPEC is effective in reducing the rate of peritoneal relapse and improving disease free and overall survival with or without adjuvant chemotherapy, when added to curative surgery in locally advanced, non-metastatic gastric cancers, the available literature is at best, heterogeneous, centre-specific and skewed. Apart from that, variations in the systemic therapy used, and the presence of the associated nodal disease further complicate this picture. To evaluate the role of p-HIPEC the PubMed, Cochrane central register of clinical trials, and the American Society of Clinical Oncology (ASCO) meeting library were searched with the search terms, "gastric", "cancer", "hyperthermic", "intraperitoneal", "chemotherapy", prophylactic", "HIPEC" in various combinations, and a critical review of the available evidence was done. Although p-HIPEC is a promising therapy in the management of locally advanced gastric cancers, the current evidence is insufficient to recommend its inclusion into routine clinical practice. Future research should be directed towards identification of the appropriate patient subset and towards redefining its role with current peri-operative systemic therapies.

Inferior Vena Cava (IVC) Resection Without Reconstruction for a Large IVC Leiomyosarcoma.

BACKGROUND: Retroperitoneal tumours arising from the inferior vena cava (IVC) are rare tumours often requiring large vessel resection for complete surgical excision. Limited exposure to such tumours often discourages surgeons from offering surgical resection to these patients, depriving them of the only potentially curative modality. We present here the surgical technique for resection of a large IVC sarcoma without IVC reconstruction. METHODS: A 53-year-old lady presented with a large retroperitoneal sarcoma encasing the infra-hepatic IVC with tumour thrombus extension into the hepatic cloaca as well as the left renal vein. Surgical resection was planned as the disease remained stable after 2 cycles of neoadjuvant chemotherapy with adriamycin and ifosfamide. RESULTS: Complete surgical excision of the tumour was achieved by performing a resection of the entire length of infra-hepatic IVC and right kidney, without IVC reconstruction. Left renal vein was divided after careful preservation of a draining collateral. Tumour thrombus was extracted from the hepatic cloaca, and proximal IVC stump closure was achieved with preservation of right hepatic vein insertion. Total blood loss during the procedure was 2300 mL, and the patient recovered without compromise of renal function or development of lower limb oedema. CONCLUSION: IVC resection without reconstruction can be safely performed for large retroperitoneal sarcomas involving major vascular structures. Familiarity with the retroperitoneal, retro-hepatic and supra-hepatic anatomy is paramount to achieving good surgical outcomes.

Interleukin-6: An Early Predictive Marker for Severity of Acute Pancreatitis.

BACKGROUND AND AIMS: Interleukin (IL)-6, IL-8, IL-10, and C-reactive protein (CRP) have been evaluated for predicting outcomes of acute pancreatitis. However, there is considerable variation in their performance among different studies. We evaluate their accuracy in predicting progression to severe pancreatitis. MATERIALS AND METHODS: Serum IL-6, IL-8, IL-10, and CRP levels were measured within 24 h of admission in forty patients of clinically predicted severe acute pancreatitis (SAP). Persistent organ failure (>48 h) defined SAP. The performance of inflammatory markers was evaluated in predicting the progression of pancreatitis. RESULTS: IL-6 ≥28.90 pg/mL had a sensitivity of 62.86%, specificity of 80%, positive predictive value (PPV) of 95.65%, LR+ of 3.1429, LR- of 0.4643, and diagnostic odds ratio (DOR) of 6.7692; IL-8 ≥88.70 pg/mL had a sensitivity of 60%, specificity of 80%, PPV of 95.45%, LR+ of 3.000, LR- of 0.5000, and DOR of 6.000; IL-10 ≤5.70 pg/mL had DOR of 0.2647, sensitivity of 51.43%, specificity of 20%, PPV of 81.82%, LR+ of 0.6429, and LR- of 2.4286. CRP ≥110.00 mg/L had DOR of 2.3636, sensitivity of 37.14%, specificity of 80%, PPV of 92.86%, LR+ of 1.8571, and LR of 0.7857. CONCLUSIONS: IL-6 ≥28.90 pg/mL, measured within 48 h of onset is the best among the tested biomarkers in this study for predicting the progression to severe pancreatitis.