Somatostatin vs. Octreotide for Prevention of Postoperative Pancreatic Fistula The PREFIPS Randomized Clinical Trial A FRENCH 007 - ACHBT Study.

OBJECTIVE: Pharmacological prevention of postoperative pancreatic fistula (POPF) after pancreatectomy is open to debate. The present study compares clinically significant POPF rates in patients randomized between somatostatin versus octreotide as prophylactic treatment. PATIENTS AND METHODS: Multicentric randomized controlled open study in patient's candidate for pancreaticoduodenectomy (PD) or distal pancreatectomy (DP) comparing somatostatin continuous intravenous infusion for 7 days versus octreotid 100 µg, every 8 hours subcutaneous injection for 7 days, stratified by procedure (PD vs. DP) and size of the main pancreatic duct (>4 mm) on grade B/C POPF rates at 90 days based on an intention-to-treat analysis. RESULTS: Of 763 eligible patients, 651 were randomized: 327 in the octreotide arm and 324 in the somatostatin arm, with comparable the stratification criteria - type of surgery and main pancreatic duct dilatation. Most patients had PD (n=480; 73.8%), on soft/normal pancreas (n=367; 63.2%) with a non-dilated main pancreatic duct (n=472; 72.5%), most often for pancreatic adenocarcinoma (n=311; 47.8%). Almost all patients had abdominal drainage (n=621; 96.1%) and 121 (19.5%) left the hospital with the drain in place (median length of stay=16 d). A total of 153 patients (23.5%) developed a grade B/C POPF with no difference between both groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (Chi-2 test, P=0.73, ITT analysis). Absence of statistically significant difference persisted after adjustment for stratification variables and in per-protocol analysis. CONCLUSIONS: Continuous intravenous somatostatin is not statistically different from subcutaneous octreotide in the prevention of grade B/C POPF after pancreatectomy.

Comparing indications, complexity and outcomes of laparoscopic liver resection between centers with and without a liver transplant program: a French nationwide study.

BACKGROUND: There are no data to evaluate the difference in populations and impact of centers with liver transplant programs in performing laparoscopic liver resection (LLR). METHODS: This was a multicenter study including patients undergoing LLR for benign and malignant tumors at 27 French centers from 1996 to 2018. The main outcomes were postoperative severe morbidity and mortality. RESULTS: A total of 3154 patients were included, and 14 centers were classified as transplant centers (N = 2167 patients, 68.7 %). The transplant centers performed more difficult LLRs and more resections for hepatocellular carcinoma (HCC) in patients who more frequently had cirrhosis. A higher rate of performing the Pringle maneuver, a lower rate of blood loss and a higher rate of open conversion (all p < 0.05) were observed in the transplant centers. There was no association between the presence of a liver transplant program and either postoperative severe morbidity (<10 % in each group; p = 0.228) or mortality (1 % in each group; p = 0.915). CONCLUSIONS: Most HCCs, difficult LLRs, and cirrhotic patients are treated in transplant centers. We show that all centers can achieve comparable safety and quality of care in LLR independent of the presence of a liver transplant program.

Defining Benchmark Outcomes for Distal Pancreatectomy: Results of a French Multicentric Study.

OBJECTIVE: Defining robust and standardized outcome references for distal pancreatectomy (DP) by using Benchmark analysis. BACKGROUND: Outcomes after DP are recorded in medium or small-sized studies without standardized analysis. Therefore, the best results remain uncertain. METHODS: This multicenter study included all patients undergoing DP for resectable benign or malignant tumors in 21 French expert centers in pancreas surgery from 2014 to 2018. A low-risk cohort defined by no significant comorbidities was analyzed to establish 18 outcome benchmarks for DP. These values were tested in high risk, minimally invasive and benign tumor cohorts. RESULTS: A total of 1188 patients were identified and 749 low-risk patients were screened to establish Benchmark cut-offs. Therefore, Benchmark rate for mini-invasive approach was ≥36.8%. Benchmark cut-offs for postoperative mortality, major morbidity grade ≥3a and clinically significant pancreatic fistula rates were 0%, ≤27%, and ≤28%, respectively. The benchmark rate for readmission was ≤16%. For patients with pancreatic adenocarcinoma, cut-offs were ≥75%, ≥69.5%, and ≥66% for free resection margins (R0), 1-year disease-free survival and 3-year overall survival, respectively. The rate of mini-invasive approach in high-risk cohort was lower than the Benchmark cut-off (34.1% vs ≥36.8%). All Benchmark cut-offs were respected for benign tumor group. The proportion of benchmark cases was correlated to outcomes of DP. Centers with a majority of low-risk patients had worse results than those operating complex cases. CONCLUSION: This large-scale study is the first benchmark analysis of DP outcomes and provides robust and standardized data. This may allow for comparisons between surgeons, centers, studies, and surgical techniques.

Is early CT in cases of elevated postoperative CRP the best option for the diagnosis of colorectal anastomotic leakage?

PURPOSE: After colorectal surgery (CRS), the early detection and treatment of anastomotic leakage (AL) is critical. We aimed to evaluate the efficacy of early contrast-enhanced computed tomography (CT) (postoperative day [POD] 2-3) after elective colorectal surgery for the diagnosis of AL for patients with elevated CRP levels at POD 2-3. METHOD: From 2017 to 2022, all patients who underwent elective CRS with an anastomosis and CRP > 150 mg/ml on POD 2-3 underwent enhanced CT during the 24 h following the CRP evaluation and were included in this retrospective, single-center study. The primary endpoint was the diagnostic value of the early CT scan for the detection of AL. The secondary endpoints were the diagnostic value of the early CT scan for the detection of grade C AL according to the type of resection and anastomosis and the quality of the opacification. RESULTS: A total of 661 patients underwent elective CRS with anastomosis with an overall AL rate of 7.4%. Among the 661 patients, 141 were finally included in the study. The accuracy of early CT for the diagnosis of AL was 83.7%. For grade C AL, the accuracy was 81.6%. Among patients who had an ileocolic anastomosis, the accuracy was 88.2%, among those who had colorectal or ileorectal anastomosis, the accuracy was 83.0%, and among those who had a coloanal, the accuracy was 66.7%. In cases of good opacification by CT, the accuracy was 84.0%. CONCLUSION: Early CT does not show perfect accuracy for an early diagnosis of AL.

The Angers CT Score is a Risk Factor for the Failure of the Conservative Management of Adhesive Small Bowel Obstruction: A Prospective Observational Multicentric Study.

BACKGROUND: Identifying the 30% of adhesive small bowel obstructions (aSBO) for which conservative management will require surgery is essential. The association between the previously described radiological score and failure of the conservative management of aSBO remains to be confirmed in a large prospective multicentric cohort. Our aim was to assess the risk factors of failure of the conservative management of aSBO considering the radiological score. MATERIAL AND METHODS: This prospective observational study took place in 15 French centers over 3 months. Consecutive patients experiencing aSBO with no early surgery were included. The six radiological features from the Angers radiological computed tomography (CT) score were noted (beak sign, closed loop, focal or diffuse intraperitoneal liquid, focal or diffuse mesenteric haziness, focal or diffuse mesenteric liquid, and diameter of the most dilated small bowel loop > 40 mm). RESULTS: Two hundred and seventy nine patients with aSBO were screened. Sixty patients (21.5%) underwent early surgery, and 219 (78.5%) had primary conservative management. In the end, 218 patients were included in the analysis of the risk factors for conservative treatment failure. Among them, 162 (74.3%) had had successful management while for 56 (25.7%) management had failed. In multivariate analysis, a history of surgery was not a significant risk factor for the failure of conservative treatment (OR = 0.11; 95%CI = 0-1.23). A previous episode of aSBO was protective against the failure of conservative treatment (OR = 0.36; 95%CI = 0.15-0.85) and an Angers CT score ≥ 5 as the only individual risk factor (OR = 2.39; 95%CI = 1.01-5.69). CONCLUSION: The radiological score of aSBO is a promising tool in improving the management of aSBO patients. A first episode of aSBO and/or a radiological score ≥5 should lead physicians to consider early surgical management.

Purse string closure of perineal defects after abdominoperineal excision.

PURPOSE: The aim of this study was to describe a new technique of perineal closure following abdominoperineal excision (APE) using purse-string perineal skin closure (PSPC). MATERIAL AND METHODS: Between January 2016 and May 2021, 15 consecutives patients who had an APE procedure were included in this retrospective single-center study. All indications of APE were considered, as well as all types of APE. We analyzed the patient characteristics and peri-operative features, including overall (Clavien 1 to 5) and severe (Clavien 3 and 4) postoperative morbidity, length of stay (LOS), and long-term results (median time to perineal wound closure and rate of perineal incisional hernia). RESULTS: The patients included 11 men and four women, with a mean age of 64 ± 13 [33-80] years. The indication of APE was an epidermoid carcinoma of the anal canal (n = 5) or an adenocarcinoma of the rectum (n = 10). The mean operating time was 220 ± 88.64 [70-360] min. The overall morbidity rate was 60%, the severe morbidity rate 26%, and reoperation rate 26%. The median length of stay was 9 ± 6.5 days. After a mean follow-up of 23.5 ± 20.3 months, the median time to perineal wound closure was 96 ± 60 days, the persistent perineal sinus rate was 6% (n = 2), and one patient developed a perineal incisional hernia. CONCLUSION: Purse-string closure of perineal wounds is a safe and effective technique for perineal wound closure after APE. The short LOS allowed an early return home.

Multiplanar CT reconstructions allow optimization of the laparoscopic surgical approach for liver lesions.

PURPOSE: Resection of hepatic lesions can be difficult and requires careful analysis of pre-operative imaging. The aim of this study is to highlight the use of multiplanar CT reconstruction in liver surgery, which helps to anticipate intra-operative technical difficulties. METHODS: We retrospectively selected the imaging of several patients managed for liver lesions in specific locations: liver dome (IVa, VIII), the left lobe (intra-parenchymal, left edge), and the antero-inferior edge of segment VI. The IWATE classification was used to grade the difficulty of these resections. RESULTS: Multiplanar analysis has made it possible to change the level of difficulty of liver resection and to anticipate intra-operative difficulties. Frontal and/or sagittal section in addition to axial sections analysis increased the IWATE score. CONCLUSION: Multi-planar reconstruction must be a tool used by the liver surgeon pre-operatively in order to limit intra-operative complications.

Risk factors for ischemia/necrosis of the colonic stump after proctectomy and delayed coloanal anastomosis.

INTRODUCTION: Delayed coloanal anastomosis (DCAA) is a two-stage procedure. DCAA has been increasingly reused in recent years in the management of rectal cancer. Such increased use of DCAA has highlighted the complications associated with this procedure. We aimed to evaluate the risk and risk factors of ischemia/necrosis of the colonic stump between the two stages of DCAA. PATIENTS AND METHODS: All patients who underwent a proctectomy with a DCAA were included in this retrospective single-centre study from November 2012 to June 2022. Two groups of patients were defined: patients with a well vascularized colonic stump (well vascularized group) and those who experienced ischemia or necrosis of the colonic stump (ischemic group). The primary endpoint was the rate of ischemia or necrosis of the colonic stump and an evaluation of the associated risk factors. RESULTS: During the study period, 43 patients underwent DCAA. Amongst them, 32 (75%) had a well-vascularized colonic stump (well-vascularized group) and 11 (25%) ischemia of the colonic stump (ischemic group). Relative to patients in the well-vascularized group, those in the ischemic group were more often men (81.8% vs 40.6%, p = 0.034), had a higher BMI (29.2 kg/m2 vs 25.7 kg/m2, p = 0.03), were more frequently diabetic (63.6% vs 21.9%, p = 0.01) and more frequently had had preoperative radiotherapy (100% vs 53.1%, p = 0.008). On the preoperative CT scan, the interspinous diameter was shorter in the ischemic group (9.4 ± 1.01 cm vs 10.6 ± 1.01 cm, p = 0.001), the intertuberosity diameter was shorter (9.2 ± 1.18 cm vs 11.9 ± 1.18 cm, p < 0.0001), and the length of the anal canal was longer (31.9 ± 3 mm vs 27.4 ± 3.2 mm, p < 0.0001). CONCLUSION: This study highlights clear risk factors for ischemia/necrosis of the colonic stump after proctectomy with DCAA.

Right portal vein ligation is still relevant for left hemi-liver hypertrophy: results of a comparative study using a propensity score between right portal vein ligation and embolization.

BACKGROUND: In two-stage hepatectomy for bilobar liver metastases from colorectal cancer, future liver remnant (FLR) growth can be achieved using several techniques, such as right portal vein ligation (RPVL) or right portal vein embolization (RPVE). A few heterogeneous studies have compared these two techniques with contradictory results concerning FLR growth. The objective of this study was to compare FLR hypertrophy of the left hemi-liver after RPVL and RPVE. STUDY DESIGN: This was a retrospective comparative study using a propensity score of patients who underwent RPVL or RPVE prior to major hepatectomy between January 2010 and December 2020. The endpoints were FLR growth (%) after weighting using the propensity score, which included FLR prior to surgery and the number of chemotherapy cycles. Secondary endpoints were the percentage of patients undergoing simultaneous procedures, the morbidity and mortality, the recourse to other liver hypertrophy procedures, and the number of invasive procedures for the entire oncologic program in intention-to-treat analysis. RESULTS: Fifty-four consecutive patients were retrospectively included and analyzed, 18 in the RPVL group, and 36 in the RPVE group. The demographic characteristics were similar between the groups. After weighting, there was no significant difference between the RPVL and RPVE groups for FLR growth (%), respectively 32.5% [19.3-56.0%] and 34.5% [20.5-47.3%] (p = 0.221). There was no significant difference regarding the secondary outcomes except for the lower number of invasive procedures in RPVL group (median of 2 [2.0, 3.0] in RPVL group and 3 [3.0, 3.0] in RPVE group, p = 0.001)). CONCLUSION: RPVL and RPVE are both effective to provide required left hemi-liver hypertrophy before right hepatectomy. RPVL should be considered for the simultaneous treatment of liver metastases and the primary tumor.

Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH).

BACKGROUND: The modulation of perioperative inflammation seems crucial to improve postoperative morbidity and cancer-related outcomes in patients undergoing oncological surgery. Data from the literature suggest that perioperative corticosteroids decrease inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery. Their benefit on cancer-related outcomes has not been assessed. METHODS: The CORTIFRENCH trial is a phase III multicenter randomized double-blind placebo-controlled trial to assess the impact of a flash dose of preoperative corticosteroids versus placebo on postoperative morbidity and cancer-related outcomes after elective curative-intent surgery for digestive cancer. The primary endpoint is the frequency of patients with postoperative major complications occurring within 30 days after surgery (defined as all complications with Clavien-Dindo grade > 2). The secondary endpoints are the overall survival at 3 years, the disease-free survival at 3 years, the frequency of patients with intraabdominal infections and postoperative infections within 30 days after surgery and the hospital length of stay. We hypothesize a reduced risk of major complications and a better disease-survival at 3 years in the experimental group. Allowing for 5% of drop-out, 1 200 patients (600 per arm) should be included. DISCUSSION: This will be the first trial focusing on the impact of perioperative corticosteroids on cancer related outcomes. If significant, it might be a strong improvement on oncological outcomes for patients undergoing surgery for digestive cancers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03875690, Registered on March 15, 2019, URL: https://clinicaltrials.gov/ct2/show/NCT03875690 .

Impact of a procalcitonin-based algorithm on the quality of management of patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome: a multicenter cluster-randomized open-label controlled trial.

BACKGROUND: Acute adhesion-related small bowel obstruction (ASBO) is a common digestive emergency, accounting for 1 to 3% of all digestive emergencies. The efficacy of conservative management in this setting is a subject of debate, as it may delay the decision to perform surgery and increase the frequency of bowel resection (e.g., in the presence of bowel necrosis) or, in contrast, prompt an excessive number of unnecessary laparotomies. Thus, the decision to perform surgery is difficult. We propose that the introduction of the procalcitonin (PCT)-based algorithm improves the quality of the management of patients with ASBO by aiding the decision of whether or not to perform surgery. METHODS: This is a 1:1 cluster-randomized clinical trial (use of algorithm: no algorithm) using an independent computer to ensure that investigators cannot interfere with the randomization. Each cluster will correspond to one investigating center. All patients in a center will be managed in the same way. Before randomization, each principal investigator will provide a commitment to participate in the study to avoid the risk of "empty clusters". The patients included will constitute two parallel arms (use of algorithm versus no algorithm), with no expected crossover between arms. The inclusion criteria are being an adult with uncomplicated acute ASBO (i.e., absence of fever, abdominal pain and distension, nausea and/or vomiting, and the absence of gas and/or stool, in conjunction with a contrast-enhanced CT scan, for patients with previous abdominal surgery) who is able to express consent with a signed written informed consent form. Patients with complicated acute ASBO (strangulation or peritonitis) will be excluded. DISCUSSION: There is an ongoing debate on the management of uncomplicated ASBO. The main points are to avoid a surgery if it is unnecessary and to avoid delayed surgery if it is necessary. Currently, there are no robust criteria to objectively determine the failure of non-surgical treatment or to establish the indications for surgery in acute ASBO. Our team proposes the use of procalcitonin (PCT) to help distinguish patients for whom conservative management is likely to be successful from those for whom surgical management is required. The results from a randomized control trial could help in the selection of patients through clear inclusion and exclusion criteria and simplify or clarify the management algorithm. In conclusion, PCT may be useful in evaluating the proper strategy for ASBO. Trial registration The trial is registered at clinical trials under the reference: NCT03905239.

Acute urinary retention and urinary tract infection after short-course urinary drainage in colon or high rectum anastomoses: Post hoc analysis of a multicentre prospective database from the GRACE group.

AIM: The aim was to define the risk factors for acute urinary retention (AUR) and urinary tract infections (UTIs) in colon or high rectum anastomosis patients based on the absence of a urinary catheter (UC) or the early removal of the UC (<24 h). METHOD: This is a multicentre, international retrospective analysis of a prospective database including all patients undergoing colon or high rectum anastomoses. Patients were part of the enhanced recovery programme audit, developed by the Francophone Group for Enhanced Recovery after Surgery, and were included if no UC was inserted or if a UC was inserted for <24 h. RESULTS: In all, 9389 patients had colon or high rectum anastomoses using laparoscopy, open surgery or robotic surgery. Among these patients, 4048 were excluded because the UC was left in place >24 h (43.1%) and 97 were excluded because the management of UC was unknown (1%). Among the 5244 colon or high rectum anastomoses patients included, AUR occurred in 5.2% and UTI occurred in 0.7%. UCs were in place for <24 h in 2765 patients (52.7%) and 2479 did not have UCs in place (47.3%). Multivariate analysis showed that management of the UC was not significantly associated with the occurrence of AUR and that risk factors for AUR were male gender, ≥65 years old, having an American Society of Anesthesiologists score ≥3 and receiving epidural analgesia. Conversely, being of male gender was a protective factor of UTI, while being ≥65 years old, having open surgery and receiving epidural analgesia were risk factors for UTIs. The management of the UC was not significantly associated with the occurrence of UTIs but the occurrence of AUR was a more significant risk factor for UTIs. CONCLUSION: UCs in place for <24 h did not reduce the occurrence of AUR or UTI compared to the absence of UCs.

Absence of abdominal drainage after surgery for secondary lower gastrointestinal tract peritonitis is a valid strategy.

BACKGROUND: Management of abdominal drainage after surgery for secondary lower gastrointestinal tract peritonitis (LGTP) is not a standardized procedure. A monocentric study was carried out in 2016 in our centre. (PI study) to evaluate the interest of drainage. Our objective was to revaluate, our actual use of abdominal drainage after peritonitis (PII study). STUDY DESIGN: We examined retrospectively patients who underwent surgery for secondary sub-mesocolic community-acquired peritonitis (January 2016-December 2019). Study exclusion criteria were primary peritonitis, peritoneal dialysis, nosocomial peritonitis, postoperative peritonitis, upper gastrointestinal tract peritonitis, peritonitis due to appendicitis, peritonitis requiring the implementation of Mikulicz's drain, and peritonitis in which the peritoneum was not described in the surgical report (i.e., the same criteria that the PI study which included 141 patients from January 2009 to January 2012). The primary endpoint was the rate of abdominal drainage. The secondary endpoints were the patient rate without a peritoneum description, major complications rate (Clavien ≥III), abscess rate, mortality rate and the length of stay in the non-drain group (D - ) and in the drain group (D + ) in PII study. Primary and secondary endpoints were also compared between PI and PII studies. Risk factors for post-operative abscess were also research. RESULTS: Of the 150 patients included 33% were drained vs 84% of the 141 patients included in PI study (p < 0.001). In PII study peritoneum was described in 80.3% of patients vs 69% in PI study (NS, p = 0.06). Comparing the two groups D - and D + , no significant differences were found in major complications (respectively 45% vs 32%, p = 0.1), reoperation rate (respectively 25% vs 22%, p = 0.7), death rate (respectively 25% vs 14%; p = 0.1) and mean length of stay (respectively 12 days vs 13 days, p = 0.9). The abscess rate was significantly lower in the D - group (10% vs 30%, p = 0.002). Comparing PI and PII studies, there was no difference about major complications (35% vs 35%, p = 0.1), reoperation (16% vs 17.5%, p = 0.5), abscess rate (15% vs 8.5%, p = 0.1) and mortality (14.5% vs 17.5%, p = 0.7). The length of stay was longer in PI study than in P II (14 days vs 9 days, p = 0.03). Drainage (p = 0.005; OR = 4.357; CI [1.559-12.173]) and peritonitis type (p = 0.032; OR = 3.264; CI [1.106-9.630]) were abscess risk factors. CONCLUSION: This study therefore showed that drainage after surgery for LGTP may not be necessary and that, at least at the local level, surgeons seem to be inclined to discontinue it systematically. It may therefore be worthwhile to conduct a randomised control trial to establish recommendations on drainage after surgery for LGTP.

Prognostic impact of surgical margins for hepatocellular carcinoma according to preoperative alpha-fetoprotein level.

BACKGROUND: HCC are known to have satellite nodules and microvascular invasions requiring sufficient margins. An alpha-fetoprotein (AFP) level >100 ng/mL is associated with worse pathological features in HCC. In practice, large resection margins, particularly >1 cm, are infrequently retrieved on the specimens. METHODS: 397 patients from 5 centres were included from 2012 to 2017. The primary endpoint was time-to-recurrence in relation to AFP level (> or <100 ng/ml) as well as surgical margins (> or <1 cm). The secondary endpoint was overall survival (OS). RESULTS: The median follow-up was 25 months. In Low AFP group, median time to recurrence (TTR) for patients with margins <1 cm was 36 months and for patients with margins ≥1 cm was 34 months (p = 0.756), and overall survival (OS) was not significantly different according to margins (p = 0.079). In High-AFP group, patients with margins <1 cm had a higher recurrence rate than patients with margins ≥1 cm (p = 0.016): median TTR for patients with margins <1 cm was 8 months whereas it was not reached for patients with margins ≥1 cm. Patients with margins <1 cm had a significantly worse OS compared to the patients with margins ≥1 cm (p = 0.043). CONCLUSION: Preoperative AFP level may help determine margins to effectively treat high AFP tumours. For low-AFP tumours, margins didn't have an impact on TTR or OS.

Predicting Intraoperative Difficulty of Open Liver Resections: The DIFF-scOR Study, An Analysis of 1393 Consecutive Hepatectomies From a French Multicenter Cohort.

OBJECTIVE: The aim of this study was to build a predictive model of operative difficulty in open liver resections (LRs). SUMMARY BACKGROUND DATA: Recent attempts at classifying open-LR have been focused on postoperative outcomes and were based on predefined anatomical schemes without taking into account other anatomical/technical factors. METHODS: Four intraoperative variables were perceived by the authors as to reflect operative difficulty: operation and transection times, blood loss, and number of Pringle maneuvers. A hierarchical ascendant classification (HAC) was used to identify homogeneous groups of operative difficulty, based on these variables. Predefined technical/anatomical factors were then selected to build a multivariable logistic regression model (DIFF-scOR), to predict the probability of pertaining to the highest difficulty group. Its discrimination/calibration was assessed. Missing data were handled using multiple imputation. RESULTS: HAC identified 2 clusters of operative difficulty. In the "Difficult LR" group (20.8% of the procedures), operation time (401 min vs 243 min), transection time (150 vs.63 minute), blood loss (900 vs 400 mL), and number of Pringle maneuvers (3 vs 1) were higher than in the "Standard LR" group. Determinants of operative difficulty were body weight, number and size of nodules, biliary drainage, anatomical or combined LR, transection planes between segments 2 and 4, 4, and 8 or 7 and 8, nonanatomical resections in segments 2, 7, or 8, caval resection, bilioentric anastomosis and number of specimens. The c-statistic of the DIFF-scOR was 0.822. By contrast, the discrimination of the DIFF-scOR to predict 90-day mortality and severe morbidity was poor (c-statistic: 0.616 and 0.634, respectively). CONCLUSION: The DIFF-scOR accurately predicts open-LR difficulty and may be used for various purposes in clinical practice and research.

Simultaneous Versus Delayed Resection for Initially Resectable Synchronous Colorectal Cancer Liver Metastases: A Prospective, Open-label, Randomized, Controlled Trial.

OBJECTIVE: To answer whether synchronous colorectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed. SUMMARY BACKGROUND DATA: Numerous studies have compared both strategies. All were retrospective and conclusions were contradictory. METHODS: Adults with colorectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications within 60 days following surgery. Secondary outcomes included overall and disease-free survival. RESULTS: A total of 105 patients were recruited. Eighty-five patients (39 and 46 in the simultaneous- and delayed-resection groups, respectively) were analyzed. The percentage of major perioperative complications did not differ between groups (49% and 46% in the simultaneous- and delayed-resection groups, respectively, adjusted OR 0.84, 95% CI 0.35-2.01; P = 0.70, logistic regression). Complications rates were 28% and 13% (P = 0.08, χ2 test) at colorectal site and 15% and 17% (P = 0.80, χ2 test) at liver site, in simultaneous- and delayed-resection groups, respectively. In the delayed-resection group, 8 patients did not reach the liver resection stage, and this was due to disease progression in 6 cases. After 2 years, overall and disease-free survival tended to be improved in simultaneous as compared with delayed-resection groups (P = 0.05), a tendency which persisted for OS after a median follow-up of 47 months. CONCLUSIONS: Complication rates did not appear to differ when colorectal cancer and synchronous liver metastases are resected simultaneously. Delayed resection tended to impair overall survival.

Root-cause Analysis of Mortality After Pancreatic Resection (CARE Study): A Multicenter Cohort Study.

OBJECTIVES: Analyze a multicenter cohort of deceased patients after pancreatectomy in high-volume centers in France by performing a root-cause analysis (RCA) to define the avoidable mortality rate. BACKGROUND: Despite undeniable progress in pancreatic surgery for over a century, postoperative outcome remains particularly worse and could be further improved. METHODS: All patients undergoing pancreatectomy between January 2015 and December 2018 and died postoperatively within 90 days after were included. RCA was performed in 2 stages: the first being the exhaustive collection of data concerning each patient from preoperative to death and the second being blind analysis of files by an independent expert committee. A typical root cause of death was defined with the identification of avoidable death. RESULTS: Among the 3195 patients operated on in 9 participating centers, 140 (4.4%) died within 90 days after surgery. After the exclusion of 39 patients, 101 patients were analyzed. The cause of death was identified in 90% of cases. After RCA, mortality was preventable in 30% of cases, mostly consequently to a preoperative assessment (disease evaluation) or a deficient postoperative management (notably pancreatic fistula and hemorrhage). An inappropriate intraoperative decision was incriminated in 10% of cases. The comparative analysis showed that young age and arterial resection, especially unplanned, were often associated with avoidable mortality. CONCLUSIONS: One-third of postoperative mortality after pancreatectomy seems to be avoidable, even if the surgery is performed in high volume centers. These data suggest that improving postoperative pancreatectomy outcome requires a multidisciplinary, rigorous, and personalized management.

Liver-First Approach for Synchronous Colorectal Metastases: Analysis of 7360 Patients from the LiverMetSurvey Registry.

BACKGROUND: The liver-first approach in patients with synchronous colorectal liver metastases (CRLM) has gained wide consensus but its role is still to be clarified. We aimed to elucidate the outcome of the liver-first approach and to identify patients who benefit at most from this approach. METHODS: Patients with synchronous CRLM included in the LiverMetSurvey registry between 2000 and 2017 were considered. Three strategies were analyzed, i.e. liver-first approach, colorectal resection followed by liver resection (primary-first), and simultaneous resection, and three groups of patients were analyzed, i.e. solitary metastasis, multiple unilobar CRLM, and multiple bilobar CRLM. In each group, patients from the three strategy groups were matched by propensity score analysis. RESULTS: Overall, 7360 patients were analyzed: 4415 primary-first, 552 liver-first, and 2393 simultaneous resections. Compared with the other groups, the liver-first group had more rectal tumors (58.0% vs. 31.2%) and higher hepatic tumor burden (more than three CRLMs: 34.8% vs. 24.0%; size > 50 mm: 35.6% vs. 22.8%; p < 0.001). In patients with solitary and multiple unilobar CRLM, survival was similar regardless of treatment strategy, whereas in patients with multiple bilobar metastases, the liver-first approach was an independent positive prognostic factor, both in unmatched patients (3-year survival 65.9% vs. primary-first 60.4%: hazard ratio [HR] 1.321, p = 0.031; vs. simultaneous resections 54.4%: HR 1.624, p < 0.001) and after propensity score matching (vs. primary-first: HR 1.667, p = 0.017; vs. simultaneous resections: HR 2.278, p = 0.003). CONCLUSION: In patients with synchronous CRLM, the surgical strategy should be decided according to the hepatic tumor burden. In the presence of multiple bilobar CRLM, the liver-first approach is associated with longer survival than the alternative approaches and should be evaluated as standard.

Short-term Outcomes of Day-Case Stoma Closure: A Prospective, Observational Study.

BACKGROUND: Elective stoma closure is a common, standardized procedure in digestive surgery. OBJECTIVE: This study aimed to evaluate the feasibility of day-case surgery for elective stoma closure. DESIGN: This is a prospective, single-center, nonrandomized study of consecutive patients undergoing day-case elective stoma closure. SETTING: This study was performed at a French tertiary hospital between January 2016 and June 2018. PATIENTS: Elective stoma closure was performed by local incision with an ASA score of I, II, or stabilized III. OUTCOME MEASURES: The primary end point was the day-case surgery success rate in the overall population (all patients having undergone elective stoma closure) and in the per protocol population (patients not fulfilling any of the preoperative or perioperative exclusion criteria). The secondary end points (in the per protocol population) were the overall morbidity rate (according to the Clavien-Dindo classification), the major morbidity rate (Clavien score ≥3), and day-case surgery quality criteria (unplanned consultation, unplanned hospitalization, and unplanned reoperation). RESULTS: Between January 2016 and June 2018, 236 patients (the overall population; mean ± SD age: 54 ± 17; 120 men (51%)) underwent elective stoma closure. Fifty of these patients (21%) met all the inclusion criteria and constituted the per protocol population. The day-case surgery success rate was 17% (40 of 236 patients) in the overall population and 80% (40 of 50 patients) in the per protocol population. In the per protocol population, the overall morbidity rate was 30% and the major morbidity rate was 6%. Of the 40 patients with successful day-case surgery, the unplanned consultation rate and the unplanned hospitalization rate were both 32.5%. There were no unplanned reoperations. LIMITATIONS: This was a single-center study. CONCLUSION: In selected patients, day-case surgery for elective stoma closure is feasible and has acceptable complication and readmission rates. Day-case elective stoma closure can therefore be legitimately offered to selected patients. See Video Abstract at http://links.lww.com/DCR/B583. RESULTADOS A CORTO PLAZO DEL CIERRE DE ESTOMA AMBULATORIO UN ESTUDIO OBSERVACIONAL Y PROSPECTIVO: ANTECEDENTES:El cierre electivo de un estoma es un procedimiento común y estandarizado en cirugía digestiva.OBJETIVO:Evaluar la viabilidad de la cirugía ambulatoria para el cierre electivo de estomas.DISEÑO:Un estudio prospectivo, unicéntrico, no aleatorizado de pacientes consecutivos sometidos a cierre de estoma electivo ambulatorio.ESCENARIO:Un hospital terciario francés entre enero de 2016 y junio de 2018.PACIENTES:Cierre electivo de estoma realizado por incisión local con una puntuación de la American Society of Anesthesiologists de I, II o III estabilizado.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal fue la tasa de éxito de la cirugía ambulatoria en la población general (todos los pacientes habiendo sido sometidos a cierre de estoma electivo) y en la población por protocolo (pacientes que no cumplían con ninguno de los criterios de exclusión preoperatorios o perioperatorios). Los resultados secundarios (en la población por protocolo) fueron la tasa de morbilidad general (según la clasificación de Clavien-Dindo), la tasa de morbilidad mayor (puntuación de Clavien ≥ 3) y los criterios de calidad de la cirugía ambulatoria (consulta no planificada, hospitalización no planificada y reoperación no planificada).RESULTADOS:Entre enero de 2016 y junio de 2018, 236 pacientes (la población general; edad media ± desviación estándar: 54 ± 17; 120 hombres (51%)) se sometieron al cierre electivo del estoma. Cincuenta de estos pacientes (21%) cumplieron todos los criterios de inclusión y constituyeron la población por protocolo. La tasa de éxito de la cirugía ambulatoria fue del 17% (40 de 236 pacientes) en la población general y del 80% (40 de 50 pacientes) en la población por protocolo. En la población por protocolo, la tasa de morbilidad general fue del 30% y la tasa de morbilidad mayor fue del 6%. De los 40 pacientes con cirugía ambulatoria exitosa, la tasa de consultas no planificadas y la tasa de hospitalización no planificada fueron ambas del 32.5%. No hubo reoperaciones no planificadas.LIMITACIONES:Este fue un estudio de un solo centro.CONCLUSIÓN:En pacientes seleccionados, la cirugía ambulatoria para el cierre electivo de estoma es factible y tiene tasas aceptables de complicaciones y reingreso. Por lo tanto, se puede ofrecer legítimamente el cierre electivo ambulatorio de estoma a pacientes seleccionados. Consulte Video Resumen en http://links.lww.com/DCR/B583.

Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high-risk Stage II and III colon cancers? Three years' follow-up results of the PRODIGE 22 phase II randomized multicentre trial.

AIM: Neoadjuvant chemotherapy has proven valuable in locally advanced resectable colon cancer (CC) but its effect on oncological outcomes is uncertain. The aim of the present paper was to report 3-year oncological outcomes, representing the secondary endpoints of the PRODIGE 22 trial. METHOD: PRODIGE 22 was a randomized multicentre phase II trial in high-risk T3, T4 and/or N2 CC patients on CT scan. Patients were randomized between 6 months of adjuvant FOLFOX (upfront surgery) or perioperative FOLFOX (four cycles before surgery and eight cycles after; FOLFOX perioperative). In wild-type RAS patients, a third arm testing perioperative FOLFOX-cetuximab was added. The primary endpoint was the tumour regression grade. Secondary endpoints were 3-year overall survival (OS), disease-free survival (DFS), recurrence-free survival (RFS) and time to recurrence (TTR). RESULTS: Overall, 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped for futility. The remaining 104 patients represented our intention-to-treat population. In the perioperative group, 96% received the scheduled four neoadjuvant cycles and all but one had adjuvant FOLFOX for eight cycles. In the control arm, 38 (73%) patients received adjuvant FOLFOX. The median follow-up was 54.3 months. Three-year OS was 90.4% in both arms [hazard ratio (HR) = 0.85], 3-year DFS, RFS and TTR were, respectively, 76.8% and 69.2% (HR=0.94), 73% and 69.2% (HR = 0.86) and 82% and 72% (HR = 0.67) in the perioperative and control arms, respectively. Forest plots did not show any subgroup with significant difference for survival outcomes. No benefit from adding cetuximab was observed. CONCLUSION: Perioperative FOLFOX has no detrimental effect on long-term oncological outcomes and may be an option for some patients with locally advanced CC.