Rectovaginal Fistula: What is the Role of Martius Flap and Gracilis Muscle Interposition in the Therapeutic Strategy?

BACKGROUND: While numerous treatments exist for management of rectovaginal fistula, none has demonstrated its superiority. The role of diverting stoma remains controversial. Few series include Martius flap in the armamentarium. OBJECTIVE: Determine the role of gracilis muscle interposition and Martius flap in the surgical management of rectovaginal fistula. DESIGN: Retrospective cohort study of a pooled prospectively maintained database from 3 centers. SETTINGS/PATIENTS: All consecutive eligible patients with rectovaginal fistula undergoing Martius flap and gracilis muscle interposition were included from 2001 to 2022. MAIN OUTCOMES: Success was defined by absence of stoma and rectovaginal fistula. RESULTS: Sixty-two patients were included with 55 Martius flap and 24 gracilis muscle interposition performed after failures of 164 initial procedures. Total length of stay was longer for gracilis muscle interposition by 2 days (p = 0.01) without a significant difference in severe morbidity (20% vs. 12%, p = 0.53). 27% of Martius flap were performed without stoma, without impact on overall morbidity (p = 0.763). Per-patient immediate success rates were not significantly different between groups (35% vs. 31%, p = 1.0). Success of gracilis muscle interposition after failure of Martius flap was not significantly different from an initial gracilis muscle interposition (p = 1.0). The immediate success rate rose to 49.4% (49% vs. 50%, p = 1.0) after simple perineal procedures. After a median follow-up of 23 months, there was no significant difference detected in success rate between the two procedures (69% vs. 69%, p = 1.0). Smoking was the only negative predictive factor (p = 0.02). LIMITATIONS: By its retrospective nature, this study is limited in its comparison. CONCLUSION: This novel comparison between Martius flap and gracilis muscle interposition suggests that Martius flap presents several advantages, including shorter length of stay, similar morbidity, and success. Proximal diversion via a stoma for Martius flap does not appear mandatory. Gracilis muscle interposition could be reserved as a salvage procedure after Martius flap failure. See Video Abstract.

Clinical care pathways of patients with biliary tract cancer: A French nationwide longitudinal cohort study.

BACKGROUND: Although the incidence of BTC is raising, national healthcare strategies to improve care lack. We aimed to explore patient clinical care pathways and strategies to improve biliary tract cancer (BTC) care. METHODS: We analysed the French National Healthcare database of all BTC inpatients between January 1, 2017 and December 31, 2021. Multinomial logistic regression adjusted odds ratios (aOR) were used to identify healthcare organisation factors that influenced access to curative care both overall and in a longitudinal sensibility analysis using optimal matching and hierarchical ascending classification to detect a subgroup of curative-care patients with a high survival over a two-year period. RESULTS: A total of 19,825 new BTC patients and three clinical care pathways (CCP) were identified: 'Palliative care' (PC-CCP), 'Non-curative Care' (NCC-CCP) and 'Curative Care' (CC-CCP) involving 7669 (38.7%), 7721 (38.9%) and 4435 (22.4%) patients respectively. Out of 1200 centers involved in BTC treatment, 84%, 11% and 5% were of low- (<15 patients/year), medium- (15-30 patients/year) and high-volume (>30 patients/year) respectively. Among patient, tumor and hospital factors, BTC management in academic (aOR: 2.32; 95%CI: 1.98-2.71), private (2.51; 2.22-2.83), semi-private (2.25; 1.91-2.65) and in high- (2.09; 1.81-2.42) or medium-volume (1.49; 1.33-1.68) centers increased probability to CC-CCP. These results were maintained in a longitudinal cluster of 2363 (53%) CC-CCP patients presenting a higher two-year survival compared with the rest [96.4% (95.1; 97.6) vs. 38.8% (36.3; 41.4), log-rank p < 0.001]. CONCLUSIONS: Among factors subject to healthcare policy improvement, the volume and type of centers managing BTC strongly influenced access to curative care.

MIRO study: Do the results of a randomized controlled trial apply in a real population?

BACKGROUND: The aim of our study was to evaluate the external validity of the MIRO randomized controlled trial findings in a similar nationwide setting "real life" population, especially the benefit of a hybrid approach in esophageal resection for pulmonary complication. The external validity of randomized controlled trial findings to the general population with the same condition remains problematic because of the inherent selection bias and rigid inclusion criteria. METHODS: This study was a cohort study from a National Health Database (Programme de Medicalisation des Systemes d'Informations) between 2010 and 2022. All adult patients operated on using Ivor Lewis resection for esophageal cancer were included. We first validated the detection algorithm of postoperative complications in the health database. Then, we assessed the primary outcome, which was the comparison of postoperative severe pulmonary complications, leak rate, and 30-day mortality between the 2 surgical approaches (hybrid versus open) over a decade. RESULTS: Between 2010 and 2012, 162 of 205 patients in the MIRO trial were anonymously identified in the health care database. No difference between randomized controlled trials and healthcare database measurements was found within severe respiratory complications (24% vs 22%, respectively) nor within leak rate (10% vs 9%, respectively). After application of selection criteria according to the MIRO trial, 3,852 patients were included between 2013 and 2022. The hybrid approach was a protective factor against respiratory complications after adjustment for confounding variables (odds ratio = 0.83; 95% confidence interval = 0.71-0.98, P = .025). No significant difference in the 30-day mortality rate or 30-day leakage rate between the types of approach was reported. CONCLUSION: This national cohort study demonstrates the external validity of the MIRO randomized controlled trial findings in a real-life population within France.

Impact of interhospital competition on mortality of patients operated on for colorectal cancer faced to hospital volume and rurality: A cross-sectional study.

INTRODUCTION: Contradictions remain on the impact of interhospital competition on the quality of care, mainly the mortality. The aim of the study is to evaluate the impact of interhospital competition on postoperative mortality after surgery for colorectal cancer in France. METHODS: We conducted a retrospective cross-sectional study from 2015 to 2019. Data were collected from a National Health Database. Patients operated on for colorectal cancer in a hospital in mainland France were included. Competition was measured using number of competitors by distance-based approach. A mixed-effect model was carried out to test the link between competition and mortality. RESULTS: Ninety-five percent (n = 152,235) of the 160,909 people operated on for colorectal cancer were included in our study. The mean age of patients was 70.4 ±12.2 years old, and female were more represented (55%). A total of 726 hospitals met the criteria for inclusion in our study. Mortality at 30 days was 3.6% and we found that the mortality decreases with increasing of the hospital activity. Using the number of competitors per distance method, our study showed that a "highly competitive" and "moderately competitive" markets decreased mortality by 31% [OR: 0.69 (0.59, 0.80); p<0.001] and by 12% respectively [OR: 0.88 (0.79, 0.99); p<0.03], compared to the "non-competitive" market. High hospital volume (100> per year) was also associated to lower mortality rate [OR: 0.74 (0.63, 0.86); p<0.001]. CONCLUSIONS: The results of our studies show that increasing hospital competition independently decreases the 30-day mortality rate after colorectal cancer surgery. Hospital caseload, patients' characteristics and age also impact the post-operative mortality.

Laparoscopic or Open Adrenalectomy for Stage I-II Adrenocortical Carcinoma: A Retrospective Study.

Surgical resection of adrenocortical carcinoma (ACC) is the only curative treatment. Even in localized (I-II) stages, open adrenalectomy (OA) is the gold standard, though laparoscopic adrenalectomy (LA) can be proposed in selected patients. Despite the postoperative benefits of LA, its role in the surgical management of patients with ACC remains controversial regarding oncologic outcomes. The aim of this retrospective study was to compare the outcomes of patients with localized ACC submitted to LA or OA in a referral center from 1995 to 2020. Among 180 consecutive patients operated on for ACC, 49 presented with localized ACC (19 LA and 30 OA). Baseline characteristics were similar between groups, except for tumor size. Kaplan-Meier estimates of 5-year overall survival were similar in both groups (p = 0.166) but 3-year disease-free survival was in favor of OA (p = 0.020). Though LA could be proposed in highly selected patients, OA should still be considered the standard approach in patients with known or suspected localized ACC.

Ambulatory appendectomy for acute appendicitis: Can we treat all the patients? A prospective study of 451 consecutive ambulatory appendectomies out of nearly 2,000 procedures.

BACKGROUND: Acute appendicitis represents the leading cause of acute gastrointestinal disorders, but only a small series regarding ambulatory appendectomies are available. The aim of this study was to report the results of ambulatory (day-case) appendectomy for acute appendicitis in a large consecutive cohort and to improve selection criteria in order to extend the indications. METHODS: All appendectomy procedures for acute appendicitis (March 2013 to June 2020) were included retrospectively. Criteria to select patients eligible for ambulatory appendectomy were based on our clinico-radiological St-Antoine's score ≥4. RESULTS: In total, 1,730 consecutive patients had an appendectomy for acute appendicitis: 1,279 (74%) in conventional settings and 451 (26%) in ambulatory settings. In the conventional group, 360 (28%) patients had surgery deferred to the next morning, whereas in the ambulatory group, 309 patients (70%) were readmitted the next morning (P < .0001). In the ambulatory group, 376 (83%) patients satisfied the criteria (score ≥4), and 90.9% were discharged on postoperative day 0. Rates of unplanned consultation and readmission were not significantly different (5.1% vs 6.6% P = .243). Multivariate analysis of the entire cohort confirmed absence of radiological perforation as highly predictive of early discharge (odds ratio = 6.073). In our cohort, these patients had an early discharge rate of 86.4% compared to 90.2% in those with a St-Antoine's score ≥4. Considering only radiological evidence of perforation as a selection criterion for ambulatory appendectomy, 581 more patients would be eligible for ambulatory surgery (+60%). CONCLUSION: Ambulatory surgery for acute appendicitis based on St-Antoine's score is safe. We propose to extend the indication for ambulatory management to all patients without radiological evidence of perforation.

Effective initial management of anastomotic leak in the maintenance of functional colorectal or coloanal anastomosis.

PURPOSE: The present study assessed the factors associated with the maintenance of a functional anastomosis in a large consecutive series of patients with anastomotic leakage (AL). METHODS: All consecutive patients presenting with AL after colorectal or coloanal anastomosis (2012-2019) were analyzed. The primary end point was a functional anastomosis without a stoma at 1 year. RESULTS: A total of 156 patients were included. AL was initially treated by antibiotics (38%), drainage (43%) or urgent surgery (19%). Initial treatment of AL was not adequate in 24.3%, and reintervention in the form of drainage or surgery was required. A total of 60.9% of patients had a functional anastomosis without a stoma 1 year after surgery. Factors associated with the risk of anastomotic failure at 1 year were diabetes (odds ratio [OR] = 4.24 [95% confidence interval {CI} 1.39-14.24] p = 0.014), neoadjuvant chemoradiotherapy (OR = 3.03 [95% CI 1.14-8.63] p = 0.03) and Grade B (OR = 6.49 [95% CI 2.23-21.74] p = 0.001) or C leak (OR = 35.35 [95% CI 9.36-168.21] p < 0.001). Among patients treated initially by drainage, side-to-end or J-pouch anastomoses were significantly associated with revision of the anastomosis compared to end-to-end (OR = 12.90, p = 0.04). CONCLUSION: After acute AL following coloanal or colorectal anastomosis, 60.9% of patients had a functional anastomosis without a stoma at the 1 year of follow-up. The type of treatment of AL influenced the risk of anastomotic failure.

Does an Ileoanal Anastomosis Decrease the Rate of Successful Pregnancy Compared With an Ileorectal Anastomosis? A National Study of 1491 Patients.

OBJECTIVE: Report the rate of successful pregnancy in a national cohort of women with either an ileal pouch anal (IPAA) or ileorectal (IRA) anastomosis constructed after colectomy for inflammatory bowel disease (IBD) or polyposis. BACKGROUND: Fertility after IPAA is probably impaired. All available data are corroborated by only small sample size studies. It is not known whether construction of IPAA versus IRA influences the odds of subsequently achieving a successful pregnancy, especially with increased utilization of the laparoscopic approach. METHODS: All women (age: 12-45 y) undergoing IRA or IPAA in France for polyposis or IBD, between 2010-2020, were included. A control population was defined as women aged from 12 to 45 years undergoing laparoscopic appendicectomy during the same period. The odds of successful pregnancy were studied using an adjusted survival analysis. RESULTS: A total of 1491 women (IPAA=872, 58%; IRA=619, 42%) were included. A total of 220 deliveries (15%) occurred during the follow-up period of 71 months (39-100). After adjustment, the odds of successful pregnancy was not significantly associated with type of anastomosis (after IPAA: Hazard Ratio [HR]=0.79, 95% confidence interval=0.56-1.11, P =0.17). The laparoscopic approach increased the odds of achieving successful pregnancy (HR=1.79, 95% confidence interval=1.20-2.63, P =0.004). IRA and IPAA significantly impacted fertility when compared with the control population ( P <0.001). CONCLUSIONS: In this large cohort study, total colectomy for polyposis or IBD was associated with reduced fertility compared with the general population. No difference in odds of achieving successful pregnancy was found between IRA and IPAA after adjustment. This analysis suggests laparoscopic surgery may be associated with greater likelihood of pregnancy.

C-reactive protein values after surgery for inflammatory bowel disease: is it still a good marker for intra-abdominal complication? A retrospective cohort study of 347 procedures : CRP after inflammatory bowel disease surgery.

PURPOSE: C-reactive protein (CRP) is a useful predictive test to early detect abdominal complication after colorectal surgery. Inflammatory bowel disease (IBD) is responsible for chronic inflammation and abnormal basal CRP that could influence the interest of its management after abdominal surgery. The aim of this study is to evaluate CRP as an indicator of postoperative complication in a specific IBD population. METHODS: Retrospective study of patients undergoing ileocolic resection or ileal pouch-anal anastomosis for IBD between 2012 and 2019. RESULTS: Ileocolic resection represents 242 patients and ileal pouch-anal anastomosis 105 patients. CRP was significantly higher at an early (105.2 ± 56.0 vs 128.1 ± 69.8; p = 0.008) and late stage (112.9 ± 72.8 vs 185.3 ± 111.5; p < 0.0001) for patients having an intra-abdominal complication. A BMI > 25 kg/m2 (p = 0.04) and an open surgical approach (p = 0.009) were associated with higher CRP levels in the first postoperative days (POD). In multivariate analysis, preoperative steroid use (p = 0.06), CRP at POD 3 > 100 mg/L (p = 0.003), and a rise between CRP values (p = 0.007) at 48 h were significantly associated with intra-abdominal complication. A CRP at POD 1 < 75 mg/L was associated with a lower rate of intra-abdominal complication (p = 0.01). A score dividing patients into 3 groups according to these values showed significant differences in intra-abdominal complication and anastomotic leakage rates. CONCLUSION: CRP is a useful predictive marker to detect abdominal complication after surgery in IBD population. Measurement of CRP can help to reduce hospitalization stay and orientate towards complementary examinations.

Outcomes Associated With Caustic Ingestion Among Adults in a National Prospective Database in France.

Importance: Caustic ingestion in adults may result in death or severe digestive sequelae. The scarcity of nationwide epidemiological data leads to difficulties regarding the applicability of their analysis to less specialized centers, which are nevertheless largely involved in the emergency management of adverse outcomes following caustic ingestion. Objective: To assess outcomes associated with caustic ingestion in adults across a nationwide prospective database. Design, Settings, and Participants: Adult patients aged 16 to 96 admitted to the emergency department for caustic ingestion between January 2010 and December 2019 were identified from the French Medical Information System Database, which includes all patients admitted in an emergency setting in hospitals in France during this period. Exposure: Esophageal caustic ingestion. Main Outcomes and Measures: The primary end point was in-hospital patient outcomes following caustic ingestion. Multivariate analysis was performed to assess independent predictors of in-hospital morbidity and mortality. Results: Among 22 657 226 patients admitted on an emergency outpatient basis, 3544 (0.016%) had ingested caustic agents and were included in this study. The median (IQR) age in this population was 49 (34-63) years, and 1685 patients (48%) were women. Digestive necrosis requiring resection was present during the primary hospital stay in 388 patients with caustic ingestion (11%). Nonsurgical management was undertaken in 3156 (89%). A total of 1198 (34%) experienced complications, and 294 (8%) died. Pulmonary complications were the most frequent adverse event, occurring in 869 patients (24%). On multivariate analysis, predictors of mortality included old age, high comorbidity score, suicidal ingestion, intensive care unit admission during management, emergency surgery for digestive necrosis, and treatment in low-volume centers. On multivariate analysis, predictors of morbidity included old age, higher comorbidity score, intensive care unit admission during management, and emergency surgery for digestive necrosis. Conclusions and Relevance: In this study, referral to expert centers was associated with improved early survival after caustic ingestion. If feasible, low-volume hospitals should consider transferring patients to larger centers instead of attempting on-site management.

Postoperative outcomes after laparoscopic or open gastrectomy. A national cohort study of 10,343 patients.

BACKGROUND: Laparoscopy for gastric cancer has not been as popular compared with other digestive surgeries, with conflicting reports on outcomes. The aim of this study focuses on the surgical techniques comparing open and laparoscopy by assessing the morbi-mortality and long-term complications after gastrectomy. METHODS: A retrospective study (2013-2018) was performed on a prospective national cohort (PMSI). All patients undergoing resection for gastric cancer with a partial gastrectomy (PG) or total gastrectomy (TG) were included. Overall morbidity at 90 post-operative days and long-term results were the main outcomes. The groups (open and laparoscopy) were compared using a propensity score and volume activity matching after stratification on resection type (TG or PG). RESULTS: A total of 10,343 patients were included. The overall 90-day mortality and morbidity were 7% and 45%, with reintervention required in 9.1%. High centre volume was associated with improved outcomes. There was no difference in population characteristics between groups after matching. An overall benefit for a laparoscopic approach after PG was found for morbidity (Open = 39.4% vs. Laparoscopy = 32.6%, p = 0.01), length of stay (Open = 14[10-21] vs. Laparoscopy = 11[8-17] days, p<0.0001). For TG, increased reintervention rate (Open = 10.8% vs. Laparoscopy = 14.5%, p = 0.04) and increased oesophageal stricture rate (HR = 2.54[1.67-3.85], p<0.001) were encountered after a laparoscopic approach. No benefit on mortality was found for laparoscopic approach in both type of resections after adjusted analysis. CONCLUSIONS: Laparoscopy is feasible for PG with a substantial benefit on morbidity and length of stay, however, laparoscopic TG should be performed with caution, with of higher rates of reintervention and oesophageal stricture.

Surgical management of insulinoma over three decades.

BACKGROUND: This paper reports our experience of the perioperative management of patients with sporadic, non-malignant, pancreatic insulinoma. METHODS: A retrospective monocentric cohort study was performed from January 1989 to July 2019, including all the patients who had been operated on for pancreatic insulinoma. The preoperative work-up, surgical management, and postoperative outcome were analyzed. RESULTS: Eighty patients underwent surgery for sporadic pancreatic insulinoma, 50 of which were female (62%), with a median age of 50 (36-70) years. Preoperatively, the tumors were localized in 76 patients (95%). Computed tomography (CT) and magnetic resonance imaging allowed exact preoperative tumor localization in 76% of the patients (64-85 and 58-88 patients, respectively), increasing to 96% when endoscopic ultrasonography was performed. Forty-one parenchyma-sparing pancreatectomies (PSP) (including enucleation, caudal pancreatectomy, and uncinate process resection) and 39 pancreatic resections were performed. The mortality rate was 6% (n = 5), with a morbidity rate of 72%, including 24 severe complications (30%) and 35 pancreatic fistulas (44%). No differences were found between formal pancreatectomy and PSP in terms of postoperative outcome procedures. The surgery was curative in all the patients. CONCLUSION: CT used in combination with endoscopic ultrasonography allows accurate localization of insulinomas in almost all patients. When possible, a parenchyma-sparing pancreatectomy should be proposed as the first-line surgical strategy.

Impact of coronavirus disease 2019 (COVID-19) lockdown on in-hospital mortality and surgical activity in elective digestive resections: A nationwide cohort analysis.

BACKGROUND: The outbreak of coronavirus disease 2019 (COVID-19) infection has led to the reorganization of hospital care in several countries. The objective was to report the postoperative mortality after elective digestive resections in a nationwide cohort during the lockdown period. METHODS: This analytic study was performed using a national billing database (the Programme de Médicalisation des Systèmes d'Informations). Patients who underwent elective digestive resections were divided in 2 groups: the lockdown group defined by hospital admissions between March 17 and May 11, 2020; and the control group, defined by hospital admissions during the corresponding period in 2019. Groups were matched on propensity score, geographical region, and surgical procedure. The primary outcome was the postoperative mortality. RESULTS: The overall population included 15,217 patients: 9,325 patients in the control group and 5,892 in the lockdown group. The overall surgical activity was decreased by 37% during the lockdown period. The overall in-hospital mortality during the hospital stay was 2.7%. After matching and adjustment, no difference in mortality between groups was reported (OR = 1.05; 95% CI: 0.83-1.34; P = .669). An asymptomatic COVID-19 infection was a risk factor for a 2-fold increased mortality, whereas a symptomatic COVID-19 infection was associated with a 10-fold increased mortality. CONCLUSION: Despite a considerable reduction in the surgical activity for elective digestive resections during the lockdown period, mortality remained stable on a nationwide scale in COVID-free patients. These findings support that systematic COVID-19 screening should be advocated before elective gastrointestinal surgery and that all efforts should be made to maintain elective surgical resection for cancer during the second wave in COVID-free patients.

Impact of Oral Immunonutrition on Postoperative Morbidity in Digestive Oncologic Surgery: A Nation-wide Cohort Study.

OBJECTIVE: The objective of the present study was to assess the effect of preoperative immunonutrition on a nationwide scale. BACKGROUND: According to international guidelines, immunonutrition should be prescribed before major oncologic digestive surgery to decrease postoperative morbidity. Nevertheless, this practice remains controversial. METHODS: We used a prospective national health database named "Echantillon généraliste des Bénéficiaires." Patients were selected with ICD10 codes of cancer and digestive surgery procedures from 2012 to 2016. Two groups were identified: with reimbursement of immunonutrition 45 days before surgery (IN-group) or not (no-IN-group). Primary outcome was 90-day severe morbidity. Secondary outcomes were postoperative length of stay (LOS) and overall survival. Logistic regression and survival analysis adjusted with IPW method were performed. RESULTS: One thousand seven hundred seventy-one patients were included. The proportion of different cancers was as follows: 72% patients were included in the colorectal group, 14% in the hepato-pancreato-biliary group, and 12% in the upper gastrointestinal group. Patients from the IN-group (n = 606, 34%) were younger (67.1 ±â€Š11.8 vs 69.2 ±â€Š12.2 years, P < 0.001), with increased use of other oral nutritional supplements (49.5% vs 31.8%, P < 0.001) and had more digestive anastomoses (89.4% vs 83.0%, P < 0.001). There was no significant difference between the 2 groups for 90-day severe morbidity [odds ratio (OR): 0.91, 95% confidence interval (95% CI): 0.73-1.14] or in survival (hazard ratio: 0.89, 95% CI: 0.73-1.08). LOS were shorter in the IN-group [-1.26 days, 95% CI: -2.40 to -0.10)]. CONCLUSION: The preoperative use of immunonutrition before major oncologic digestive surgery was not associated with any significant difference in morbidity or mortality. However, the LOS was significantly shorter in the IN-group.

Prognostic value of tumor deposits in rectal cancer: A monocentric series of 505 patients.

BACKGROUND AND OBJECTIVES: It has been suggested that tumor deposits (TDs) may have a worse prognosis in rectal cancer compared with colonic cancer. The aim of this study was to assess TDs prognosis in rectal cancer. METHODS: Patients who underwent total mesorectum excision for rectal adenocarcinoma (2011-2016) were included. A case-matched analysis was performed to assess the accurate impact of TDs for each pN category after exclusion of synchronous metastasis. RESULTS: A total of 505 patients were included. TDs were observed in 99 (19.6%) patients, (pN1c = 37 [7.3%]). TDs were associated with pT3-T4 stage (P = .037), synchronous metastasis (P = .003), lymph node (LN) invasion (P = .041), vascular invasion (P = .001), and perineural invasion (P < .001). TD was associated with a worse 3-year disease-free survival (DFS) among pN0 (51.2% vs 79.8%; P < .001); pN1 patients (35.2% vs 70.1%; P = .004) but not among pN2 patients (37.5% vs 44.7%; P = .499). After matching, pN1c patients had a worse 3-year DFS compared with pN0 patients (58.6% vs 82.4%; P = .035) and a tendency toward a worse DFS among N1 patients (40.1% vs 64.2%; P = .153). DFS was worse when one TD was compared with one invaded LN (40.8% vs 81.3%; P < .001). CONCLUSION: In rectal cancer, TDs have a metastatic risk comparable to a pN2 stage which may lead to changes in adjuvant treatment.

Study Protocol of the PreFiPS Study: Prevention of Postoperative Pancreatic Fistula by Somatostatin Compared With Octreotide, a Prospective Randomized Controlled Trial.

Background: Pancreatic fistula (PF), i. e., a failure of the pancreatic anastomosis or closure of the remnant pancreas after distal pancreatectomy, is one of the most feared complications after pancreatic surgery. PF is also one of the most common complications after pancreatic surgery, occurring in about 30% of patients. Prevention of a PF is still a major challenge for surgeons, and various technical and pharmacological interventions have been investigated, with conflicting results. Pancreatic exocrine secretion has been proposed as one of the mechanisms by which PF occurs. Pharmacological prevention using somatostatin or its analogs to inhibit pancreatic exocrine secretion has shown promising results. We can hypothesize that continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10-50 times stronger affinity with all somatostatin receptor compared with somatostatin analogs, will be associated with an improved PF prevention. Methods: A French comparative randomized open multicentric study comparing somatostatin vs. octreotide in adult patients undergoing pancreaticoduodenectomy (PD) or distal pancreatectomy with or without splenectomy. Patients with neoadjuvant radiation therapy and/or neoadjuvant chemotherapy within 4 weeks before surgery are excluded from the study. The main objective of this study is to compare 90-day grade B or C postoperative PF as defined by the last ISGPF (International Study Group on Pancreatic Fistula) classification between patients who receive perioperative somatostatin and octreotide. In addition, we analyze overall length of stay, readmission rate, cost-effectiveness, and postoperative quality of life after pancreatic surgery in patients undergoing PD. Conclusion: The PreFiPS study aims to evaluate somatostatin vs. octreotide for the prevention of postoperative PF.