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In this randomized trial involving patients with necrotizing pancreatitis, a less invasive step-up approach (percutaneous drainage followed, if necessary, by minimally invasive retroperitoneal necrosectomy) was associated with fewer complications than open necrosectomy. In patients with necrotizing pancreatitis, a less invasive step-up approach (percutaneous drainage followed, if necessary, by minimally invasive retroperitoneal necrosectomy) was associated with fewer complications than open necrosectomy. Acute pancreatitis is the third most common gastrointestinal disorder requiring hospitalization in the United States, with annual costs exceeding $2 billion. 1 , 2 Necrotizing pancreatitis, which is associated with an 8 to 39% rate of death, develops in approximately 20% of patients. 3 The major cause of death, next to early organ failure, is secondary infection of pancreatic or peripancreatic necrotic tissue, leading to sepsis and multiple organ failure. 4 Secondary infection of necrotic tissue in patients with necrotizing pancreatitis is virtually always an indication for intervention. 3 , 5 – 7 The traditional approach to the treatment of necrotizing pancreatitis with secondary infection of necrotic . . .

A multicenter, randomized trial of patients with infected necrotizing pancreatitis evaluated immediate drainage within 24 hours after infected necrosis was diagnosed as compared with postponed drainage. Immediate drainage was not superior to postponed drainage in reducing complications. Patients assigned to immediate drainage underwent a greater number of invasive procedures.

Background:As with endoscopic transmural drainage of peripancreatic fluid collections, the same transluminal access can be expanded to introduce an endoscope through the gastrointestinal wall into the retroperitoneum and remove infected pancreatic necroses under direct visual control. This study reports the first large series with long-term follow-up.Methods:Data for all patients undergoing transluminal endoscopic removal of (peri)pancreatic necroses between 1999 and 2005 in six different centres were collected retrospectively, and the patients were followed up prospectively until 2008. The initial patient and treatment outcome data were recorded, as were long-term results.Results:Ninety-three patients (63 men, 30 women; mean age 57 years) underwent a mean of six interventions starting at a mean of 43 days after an attack of severe acute pancreatitis. After establishment of transluminal access to the necrotic cavity and subsequent endoscopic necrosectomy, initial clinical success was obtained in 80% of the patients, with a 26% complication and a 7.5% mortality rate at 30 days. After a mean follow-up period of 43 months, 84% of the initially successfully treated patients had sustained clinical improvement, with 10% receiving further endoscopic and 4% receiving surgical treatment for recurrent cavities; 16% suffered recurrent pancreatitis.Conclusions:Direct transluminal endoscopic removal of pancreatic necroses is associated with good long-term maintenance of the high initial efficacy; complications can occur, with an associated mortality of around 7.5%. Further studies are necessary in order to optimise endotherapy and define its role in relation to surgery in the clinical management of such patients.

BackgroundProphylactic somatostatin to reduce the incidence of clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy remains controversial. We assessed the preventive efficacy of somatostatin on clinically relevant postoperative pancreatic fistula in intermediate-risk patients who underwent pancreaticoduodenectomy at pancreatic centres in China.MethodsIn this multicentre, prospective, randomised controlled trial, we used the updated postoperative pancreatic fistula classification criteria and cases were confirmed by an independent data monitoring committee to improve comparability between centres. The primary endpoint was the rate of clinically relevant postoperative pancreatic fistula within 30 days after pancreaticoduodenectomy.ResultsEligible patients (randomised, n = 205; final analysis, n = 199) were randomised to receive postoperative intravenous somatostatin (250 μg/h over 120 h; n = 99) or conventional therapy (n = 100). The primary endpoint was significantly lower in the somatostatin vs control group (n = 13 vs n = 25; 13% vs 25%, P = 0.032). There were no significant differences for biochemical leak (P = 0.289), biliary fistula (P = 0.986), abdominal infection (P = 0.829), chylous fistula (P = 0.748), late postoperative haemorrhage (P = 0.237), mean length of hospital stay (P = 0.512), medical costs (P = 0.917), reoperation rate (P > 0.99), or 30 days’ readmission rate (P = 0.361). The somatostatin group had a higher rate of delayed gastric emptying vs control (n = 33 vs n = 21; 33% vs 21%, P = 0.050).ConclusionsProphylactic somatostatin treatment reduced clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy.Trial registrationNCT03349424.

BackgroundThe pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy.MethodsPatients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay.ResultsOverall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2–20.0, p = 0.032).ConclusionThe present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.

Intraoperative fluid balance significantly affects patients' outcomes. Goal-directed fluid therapy (GDFT) has reduced the incidence of major postoperative complications by 20% for 30 days after open abdominal surgery. Little is known about GDFT during laparoscopic surgery. We investigated whether GDFT affects the postoperative outcomes in laparoscopic hepatobiliary or pancreatic surgery compared with conventional fluid management. This interventional comparative study with a historical control group was performed in the tertiary care center. Patients were allocated to one of two groups. The GDFT (n = 147) was recruited prospectively and the conventional group (n = 228) retrospectively. In the GDFT group, fluid management was guided by the stroke volume (SV) and cardiac index (CI), whereas it had been performed based on vital signs in the conventional group. Propensity score (PS) matching was performed to reduce selection bias (n = 147 in each group). Postoperative complications were evaluated as primary outcome measures. The amount of crystalloid used during surgery was less in the GDFT group than in the conventional group (5.1 ± 1.1 vs 6.3 ± 1.8 ml/kg/h, respectively; P <0.001), whereas the amount of colloid was comparable between the two groups. The overall proportion of patients who experienced any adverse events was 57.8% in the GDFT group and 70.1% in the conventional group (P = 0.038), of which the occurrence of pleural effusion was significantly lower in the GDFT group than in the conventional group (9.5% vs. 19.7%; P = 0.024). During the postoperative period, the proportion of patients admitted to the intensive care unit (ICU) was lower in the GDFT group than that in the conventional group after PS matching (4.1% vs 10.2%; P = 0.049). GDFT based on SV and CI resulted in a lower net fluid balance than conventional fluid therapy. The overall complication rate in laparoscopic hepatobiliary or pancreatic surgery decreased after GDFT, and the frequency of pleural effusion was the most affected.

Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023

Subgroup analysis aims to identify subgroups (usually defined by baseline/demographic characteristics), who would (or not) benefit from an intervention under specific conditions. Often performed post hoc (not pre-specified in the protocol), subgroup analyses are prone to elevated type I error due to multiple testing, inadequate power, and inappropriate statistical interpretation. Aside from the well-known Bonferroni correction, subgroup treatment interaction tests can provide useful information to support the hypothesis. Using data from a previously published randomized trial where a p value of 0.015 was found for the comparison between standard and Hemopatch® groups in (the subgroup of) 135 patients who had hand-sewn pancreatic stump closure we first sought to determine whether there was interaction between the number and proportion of the dependent event of interest (POPF) among the subgroup population (patients with hand-sewn stump closure and use of Hemopatch®), Next, we calculated the relative excess risk due to interaction (RERI) and the “attributable proportion” (AP). The p value of the interaction was p  = 0.034, the RERI was − 0.77 ( p  = 0.0204) (the probability of POPF was 0.77 because of the interaction), the RERI was 13% (patients are 13% less likely to sustain POPF because of the interaction), and the AP was − 0.616 (61.6% of patients who did not develop POPF did so because of the interaction). Although no causality can be implied, Hemopatch® may potentially decrease the POPF after distal pancreatectomy when the stump is closed hand-sewn. The hypothesis generated by our subgroup analysis requires confirmation by a specific, randomized trial, including only patients undergoing hand-sewn closure of the pancreatic stump after distal pancreatectomy. Trial registration: INS-621000-0760.

Pancreas divisum is the most common anatomical variation of pancreatic ductal system affecting 5–10% of population. Therapy includes different endoscopic and surgical procedures. The aim of this article was to summarize actual evidence of different treatment. A Medline search was performed to identify all studies, investigating endoscopic or surgical therapy of Pancreas divisum. An individual data simulation model was applied to compare endoscopic and surgical studies. 56 observational studies (31 endoscopic and 25 surgical studies) were included in analyses. Surgery was significantly superior to endoscopic treatment in terms of success rate (72% vs. 62.3), complication rate (23.8% vs. 31.3%) and re-intervention rate (14.4% vs. 28.3%). Surgery may be superior to endoscopy in terms of treatment success and complications. There is no study comparing these two therapies. Consequently, a randomized trial is needed to clarify if endoscopy or surgery is superior in the therapy of pancreas divisum. •Surgery seems still superior to endoscopic treatment, especially in terms of success rate, complication rate and re-intervention rate.•There is no study comparing endoscopic and surgical therapy of pancreas divisum. Thus, a randomized trial is needed to clarify which type of therapy is superior.

Surgery remains a challenge for young learners. Perhaps the most difficult of all surgeries are those done on the liver, biliary tree and pancreas. These organs are difficult to expose, difficult to operate and the patients are often difficult to recover. There are significant consequences for any missteps on what is a narrow pathway to a successful outcome.The skills needed to master surgery on these organs are hard to acquire. The volume of information presented to students is enormous and complex to parse. HPB textbooks contain a large amount of information from various authors but are often poorly coordinated. Surgical manuals contain significant anatomic details and descriptions but have difficulty transferring key concepts. Experienced surgeons are often oblivious to their skills and communicate poorly to their students regarding the things they do or understand that make them wise. This book tries to capture this wisdom.The topics in this book are most applicable to hepatobiliary and pancreatic surgeons but really extend to all general surgeons. Anyone who operates in the abdomen must have a basic understanding of these dominant organs, general surgery trainees and staff are an additional focus of this book. The skills needed for a modern surgeon to succeed are much broader than the scalpel tip. Section I, \"HPB Surgical Craft\", imparts important lessons on the laws of human interactions and cognitive aspects of surgery. Sections on the anatomy and operations on the liver, pancreas and bile ducts are presented. The expanded gallbladder section and pancreatitis chapters are of particular importance to general surgery residents. This book has been written in a readable and entertaining style, with many fun historical and contemporary quotes dotted throughout.The Wise Scalpel is an attempt to impart knowledge and understanding to students and practicing surgeons at all levels. The book focuses on tips, traps and underlying truths about the diseases of these organs and their surgical treatment. While this book will not supplant the struggle needed to move from novice to expert surgeon, hopefully it will quicken the process and help avoid some of the dangers and frustrations along the way.