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Postoperative pancreatic fistula is a common complication of pancreatic surgery. In this trial, patients undergoing pancreatic resection who received pasireotide, a somatostatin analogue, had a decreased occurrence of postoperative pancreatic fistula, leak, or abscess. Although mortality after pancreatectomy has decreased to approximately 2% at high-volume centers, the operative morbidity after these procedures has remained between 30% and 50%. 1 , 2 Postoperative pancreatic fistula, leak, and abscess are complications that result from leakage of pancreatic exocrine secretions at the anastomosis or closure of the pancreatic remnant. Postoperative pancreatic fistula is the most common major complication after pancreatectomy, with reported rates between 10% and 28%. Studies suggest that patients in whom postoperative pancreatic fistula develops have a risk of death that is approximately doubled. 3 , 4 Because of the magnitude of this problem, numerous studies have investigated methods . . .

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.

BackgroundOutcomes of pancreaticojejunostomy without pancreatic duct during open pancreaticoduodenectomy (OPD) are unknown and controversial, and corresponding reports in laparoscopic surgery are lacking.MethodsPatients were evaluated at West China Hospital, and standard laparoscopic pancreaticoduodenectomy (LPD) was planned. A prospective randomized trial was conducted, in which the patients were randomly assigned to the no-stent and internal-stent groups in a single-center trial. The primary outcomes were the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) and 90-day mortality. Preliminary results were reported.ResultsFrom November 2019 to March 2021, we enrolled 90 patients (41 in the no-stent group and 49 in the internal-stent group) in the study. All baseline parameters of both groups, including age, sex ratio, pancreatic duct diameter, and intraoperative blood loss, were comparable between the two groups except for pathological diagnosis and the texture of remnants. Twenty-seven (65.9%) and 19 (38.8%) patients in the no-stent and internal-stent groups, respectively, had soft pancreatic remnants (P = 0.010). The total incidence of CR-POPF was 5.6% and included two patients (4.9%) in the no-stent group and three patients (6.1%) in the internal-stent group (P = 1.000). Only one patient in the internal-stent group died of heart failure within 90 days after the operation. No significant difference in other postoperative complications was observed between the groups except for biochemical fistula [no-stent group vs. internal-stent group = 31.7% vs. 12.2%, (P = 0.024)].ConclusionsIn a high-volume LPD center, duct-to-mucosa pancreaticojejunostomy without pancreatic duct stent is safe and reliable. In addition, duct-to-mucosa pancreaticojejunostomy without pancreatic duct stent was more challenge. We recommend using the stent during anastomosis and pulling it out after the procedure.

Postoperative pancreatic fistula is the leading cause of death and morbidity after pancreaticoduodenectomy. However, the best reconstruction method to reduce occurrence of fistula is debated. We did a multicentre, randomised superiority trial to compare the outcomes of different reconstructive techniques in patients undergoing pancreaticoduodenectomy for pancreatic or periampullary tumours. Patients aged 18–85 years with confirmed or suspected neoplasms of the pancreas, distal bile duct, ampulla vateri, duodenum, or periampullary tumours were eligible for inclusion. An internet-based platform was used to randomly assign patients to either pancreaticojejunostomy or pancreaticogastrostomy as reconstruction after pancreaticoduodenectomy, using permuted blocks with six patients per block. Within each centre the randomisation was stratified on the pancreatic duct diameter (≤3 mm vs >3 mm) measured at the time of surgery. The primary endpoint was the occurrence of clinical postoperative pancreatic fistula (grade B or C) as defined by the International Study Group on Pancreatic Fistula. The study was not masked and analyses were done by intention to treat. Patient follow-up was closed 2 months after discharge from the hospital. This study is registered with ClinicalTrials.gov, number NCT00830778. Between June, 2009, and August, 2012, we randomly allocated 167 patients to receive pancreaticojejunostomy and 162 to receive pancreaticogastrostomy. 33 (19·8%) patients in the pancreaticojejunostomy group and 13 (8·0%) in the pancreaticogastrostomy group had clinical postoperative pancreatic fistula (OR 2·86, 95% CI 1·38–6·17; p=0·002). The overall incidence of postoperative complications did not differ significantly between the groups (99 in the pancreaticojejunostomy group vs 100 in the pancreaticogastrostomy group), although more events in the pancreaticojejunostomy group were of grade ≥3a than in the pancreaticogastrostomy group (39 vs 35). In patients undergoing pancreaticoduodenectomy for pancreatic head or periampullary tumours, pancreaticogastrostomy is more efficient than pancreaticojejunostomy in reducing the incidence of postoperative pancreatic fistula. Funding Johnson & Johnson Medical Devices, Belgium.

Purpose Radical gastrectomy with D2 lymphadenectomy can trigger a high incidence of postoperative pancreatic fistula (POPF), which produces a poor clinical prognosis. We sought to evaluate the effect of somatostatin analogs (SSA) on POPF and clinical prognosis after radical gastrectomy. Methods A total of 123 patients with a high risk of POPF after radical gastrectomy (drainage fluid amylase concentration on a postoperative day [POD] 1 > 3 times the upper limit of normal serum amylase value) were randomly divided into the SSA group ( n  = 61) and the control group ( n  = 62). The former received continuous intravenous SSA (0.3 mg/8 h) for 3 days from POD1, and the latter normal saline. The primary outcome was the incidence of POPF. Results The incidence of POPFs in the SSA group was significantly lower than that in the control group (3.3% vs. 14.5%, P  = 0.029). The incidence of short-term postoperative complications was significantly lower in the SSA group than in the control group (9.8% vs. 24.2%, P  = 0.034). The median white blood cell counts, neutrophil counts, and the percentage of neutrophils on POD4 were significantly lower in the SSA group than in the control group (all P  < 0.05). The SSA group had a shorter mean time to the first liquid diet (87.33 ± 17.92 h vs. 93.97 ± 17.29 h, P  = 0.039). And the SSA group had less median daily drainage volume (96.33 mL vs. 119.67 mL, P  = 0.025) and shorter drainage duration (7.0 days vs. 10.0 days, P  = 0.013). Conclusion Postoperative treatment with a somatostatin analog reduced the incidence of POPF and short-term complications after radical gastrectomy. (TRN: ChiCTR2200056201, Reg. Date: 2022/2/1).

The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53–1·33; p=0·56). One patient died within the first 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. German Federal Ministry of Education and Research.

The aim of this study is to evaluate the effectiveness of TachoSil sponge on distal pancreatectomy remnant stump in reducing the rate and severity of postoperative pancreatic fistula (POPF). All consecutive patients requiring distal pancreatectomy were randomized in 45 centers. The principal end point was onset of “clinically relevant” POPF. Univariate and multivariate analyses were searched for predictive factors. Of the 270 patients randomized (134 with TachoSil; 136 without), 150 (55.6%) patients sustained a POPF [74 clinically relevant and 76 clinically silent (27.4% and 28.1%), respectively]: no statistically significant difference was found between patients sustaining clinically relevant POPF [41 (30.6%) with vs 33 (24.3%) without TachoSil (P = .276)], or overall POPF [73 (54.5%) with vs 77 (56.6%) without TachoSil, (P = .807)], but there were more clinically relevant POPF after hand-sewn (32.3%) versus mechanical closure (19.8%) (P = .025) and, in case of splenic preservation, after splenic vessel ligation (15/32, 46.9%) versus vascular preservation (17/72, 23.6%) (P = .024). Hand-sewn pancreatic remnant closure (P = .023) and splenic vessel ligation in splenic preservation (P = .035) were independent predictive factors for the onset of clinically relevant POPF. TachoSil sponge reinforcement of the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF. •Several procedures have been proposed to reduce the rate and/or severity of POPF.•This multicenter controlled randomized trial evaluated the usefulness of TachoSil sponge on remnant stump in reducing the rate and severity of POPF.•TachoSil sponge on the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF.•Hand-sewn pancreatic remnant closure and splenic vessel ligation in splenic preservation were independent predictive factors for the onset of clinically patent POPF.•Negative studies must be published to avoid publication and reporting bias before drawing methodologically sound conclusions as to the usefulness or futility of therapeutic decisions.

Prophylactic abdominal drainage is current standard practice after distal pancreatectomy (DP), with the aim to divert pancreatic fluid in case of a postoperative pancreatic fistula (POPF) aimed to prevent further complications as bleeding. Whereas POPF after pancreatoduodenectomy, by definition, involves infection due to anastomotic dehiscence, a POPF after DP is essentially sterile since the bowel is not opened and no anastomoses are created. Routine drainage after DP could potentially be omitted and this could even be beneficial because of the hypothetical prevention of drain-induced infections (Fisher, Surgery 52:205-22, 2018). Abdominal drainage, moreover, should only be performed if it provides additional safety or comfort to the patient. In clinical practice, drains cause clear discomfort. One multicenter randomized controlled trial confirmed the safety of omitting abdominal drainage but did not stratify patients according to their risk of POPF and did not describe a standardized strategy for pancreatic transection. Therefore, a large pragmatic multicenter randomized controlled trial is required, with prespecified POPF risk groups and a homogeneous method of stump closure. The objective of the PANDORINA trial is to evaluate the non-inferiority of omitting routine intra-abdominal drainage after DP on postoperative morbidity (Clavien-Dindo score ≥ 3), and, secondarily, POPF grade B/C. Binational multicenter randomized controlled non-inferiority trial, stratifying patients to high and low risk for POPF grade B/C and incorporating a standardized strategy for pancreatic transection. Two groups of 141 patients (282 in total) undergoing elective DP (either open or minimally invasive, with or without splenectomy). Primary outcome is postoperative rate of morbidity (Clavien-Dindo score ≥ 3), and the most relevant secondary outcome is grade B/C POPF. Other secondary outcomes include surgical reintervention, percutaneous catheter drainage, endoscopic catheter drainage, abdominal collections (not requiring drainage), wound infection, delayed gastric emptying, postpancreatectomy hemorrhage as defined by the international study group for pancreatic surgery (ISGPS) (Wente et al., Surgery 142:20-5, 2007), length of stay (LOS), readmission within 90 days, in-hospital mortality, and 90-day mortality. PANDORINA is the first binational, multicenter, randomized controlled non-inferiority trial with the primary objective to evaluate the hypothesis that omitting prophylactic abdominal drainage after DP does not worsen the risk of postoperative severe complications (Wente etal., Surgery 142:20-5, 2007; Bassi et al., Surgery 161:584-91, 2017). Most of the published studies on drain placement after pancreatectomy focus on both pancreatoduodenectomy and DP, but these two entities present are associated with different complications and therefore deserve separate evaluation (McMillan et al., Surgery 159:1013-22, 2016; Pratt et al., J Gastrointest Surg 10:1264-78, 2006). The PANDORINA trial is innovative since it takes the preoperative risk on POPF into account based on the D-FRS and it warrants homogenous stump closing by using the same graded compression technique and same stapling device (de Pastena et al., Ann Surg 2022; Asbun and Stauffer, Surg Endosc 25:2643-9, 2011).

Background Pancreaticoduodenectomy is a highly difficult and invasive type of gastrointestinal surgery. Prevention of postoperative pancreatic fistula is important, and this may be possible by the stapler method. Methods STRAP-PD is a single center randomized controlled trial. We compare a method of transecting the pancreatic parenchyma in pancreaticoduodenectomy using a surgical stapler device with a conventional transecting method using energy devices (e.g., scalpel, ultrasonic coagulator and incision devices). Patients with soft pancreas who are scheduled to undergo pancreaticoduodenectomy are randomized to arm A (conventional method) or arm B (stapler method). We aim to examine the safety and usefulness of dissection by the automatic suture device, with attention to the rate of pancreatic fistula ISGPF grade B or C and to postoperative complications. This is a single-center randomized study, which began in September 2023 at Wakayama Medical University Hospital. Discussion Pancreatic parenchymal transection is typically performed either by direct incision using a scalpel or by employing energy devices such as ultrasonic coagulating cutting devices during pancreaticoduodenectomy. In a prospective pilot study, we conducted pancreatic parenchymal transection in 20 consecutive normal pancreatic cases during pancreaticoduodenectomy, observing postoperative pancreatic fistula grade B in one case (5%). Traditional methods involving scalpel incision or the use of ultrasonic coagulating cutting devices have been historically favored but perceived as technically challenging, and they have been reliant upon the surgeon's skill. Notably, relatively high incidences of postoperative pancreatic fistula among patients with soft pancreas have also been observed. Our proposed stapler method may therefore be a useful method responsible for reducing the development of pancreatic fistula. This method would be as part of minimally-invasive surgery for pancreaticoduodenectomy. It uses an endoscopic linear stapler to cut the pancreatic parenchyma, so it is likely to be more convenient than conventional methods and can be used universally. Trial registration University Hospital Medical Information Network Clinical Trials Registry, UMIN000052089. the Registration Date on 1st September 2023.

Background Complications after pancreatoduodenectomy occur in up to 40% of patients. Postoperative pancreatic fistula (POPF) remains the most common complication after pancreatoduodenectomy and is associated with increased postoperative mortality. The cavitron ultrasonic surgical aspirator (CUSA) is a surgical instrument commonly used in liver and neurosurgery. The CUSA selectively dissects tissue parenchyma, leaving blood vessels and bile ducts undamaged, which are then selectively ligated or clipped. Only a few studies have investigated the relationship between the transection of pancreatic tissue with CUSA and the formation of POPF. The results were inconsistent and were published before the updated ISGPS consensus on the definition of POPF. Methods The PANCUT study is a randomised controlled trial initiated at the Department of Abdominal Surgery, University Medical Centre Ljubljana. The aim of the study is to determine whether precise dissection of the pancreatic tissue with CUSA reduces the incidence of POPF. Patients scheduled for pancreatoduodenectomy will be randomly assigned to either the experimental group, in which the pancreatic tissue will be dissected with CUSA, or the control group, in which pancreas will be conventionally transected with scalpel. A total of 180 patients will be included in the study. The primary endpoint is the formation of POPF. Secondary endpoints include operation time, amount of intraoperative blood loss, postoperative infectious complications, postoperative bleeding, length of hospital stay and mortality. Discussion To our knowledge, the PANCUT study is the first randomized controlled trial to investigate the role of CUSA in the transection of pancreatic tissue during pancreatoduodenectomy. Trial registration ClinicalTrials.gov NCT06135012. Registered on 18 November 2023.