Dataset Information

One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Although various pancreaticojejunal duct-to-mucosa anastomosis methods have been developed to reduce the postoperative risks of pancreaticoduodenectomy, pancreatic fistula remains the most serious complication with a high incident rate. The aim of this study is to compare the safety and effectiveness of one-layer and two-layer duct-to-mucosa pancreaticojejunostomy in patients undergoing pancreaticoduodenectomy.

Methods/design

In this study, adult patients who sign consent forms will be recruited and scheduled for elective pancreaticoduodenectomy. One hundred and fourteen patients will be included and randomized before pancreaticojejunal reconstruction and after resection of the lesion from the pancreatic or periampullary region. The primary efficacy endpoint is the incident rate of postoperative pancreatic fistula. Statistical analysis will be based on the intention-to-treat population. Patients will be followed up for 3 months by monitoring for complications and other adverse events.

Discussion

This prospective, single-center, randomized, single-blinded, two-group parallel trial is designed to compare one-layer with two-layer duct-to-mucosa anastomosis for pancreaticojejunal anastomosis during elective pancreaticoduodenectomy.

Trial registration

Clinical Trials.gov: NCT02511951 . Registered on 29 July 2015.

SUBMITTER: Pan SB

PROVIDER: S-EPMC4988010 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial.

Pan Shu-Bo SB Geng Wei W Zhou Da-Chen DC Chen Jiang-Ming JM Zhao Hong-Chuan HC Liu Fu-Bao FB Xie Sheng-Xue SX Hou Hui H Zhao Yi-Jun YJ Xie Kun K Wang Guo-Bin GB Geng Xiao-Ping XP

Trials 20160817 1

<h4>Background</h4>Although various pancreaticojejunal duct-to-mucosa anastomosis methods have been developed to reduce the postoperative risks of pancreaticoduodenectomy, pancreatic fistula remains the most serious complication with a high incident rate. The aim of this study is to compare the safety and effectiveness of one-layer and two-layer duct-to-mucosa pancreaticojejunostomy in patients undergoing pancreaticoduodenectomy.<h4>Methods/design</h4>In this study, adult patients who sign conse ...[more]

PMID: 27530630

Similar Datasets

Project description:BackgroundPostoperative pancreatic fistula (POPF) is often associated with significant morbidity and mortality after the Whipple operation. Patient-related factors associated with POPF include soft pancreatic texture and a small main pancreatic duct (MPD). The traditional duct-to-mucosa anastomosis was modified to be easily performed. The aim of the study was to evaluate the simplified pancreaticojejunostomy (PJ) method in the prevention of POPF after minimally invasive pancreaticoduodenectomy (PD).MethodsNinety-eight patients who underwent laparoscopic pancreaticoduodenectomy (LPD) and robotic pancreaticoduodenectomy (RPD) with a simplified PJ procedure containing only two duct-to-mucosa sutures and four penetrating-sutures to anastomose the pancreatic parenchyma and jejunal seromuscular layer in our center were retrospectively studied. Demographics and clinical short-term safety were assessed.ResultsAll LPD and RPD procedures were successfully performed. The median time of PJ was 17 min, and the median blood loss was 60 mL, with only one patient requiring transfusion. Four patients (4.1%) suffered from clinically relevant POPF (CR-POPF), including four grade B cases and no grade C cases. For patients with an MPD diameter of 3 mm or less, POPF was noted in two (4%) of the fifty patients, with all cases being grade B. Of the patients with a soft pancreas, only two (4.5%) patients suffered from grade B POPF. One patient (1.0%) experienced a 90-day mortality. Neither the main pancreatic diameter nor pancreatic texture had an impact on postoperative outcomes.ConclusionsOur technique is a simple, safe and efficient alternative to prevent POPF after LPD and RPD. This method is suitable for almost all pancreatic conditions, including cases with a small main pancreatic duct and soft pancreas, and has the potential to become the preferred procedure in low-volume pancreatic surgery centers. Our modified duct-to-mucosa PJ, which contains only two duct-to-mucosa sutures and four penetrating-sutures to anastomose the pancreatic parenchyma and jejunal seromuscular layer, is ideal for small MPD and soft pancreas when performing minimally invasive PD and has a low rate of POPF. PJ pancreaticojejunostomy, MPD main pancreatic diameter, PD pancreaticoduodenectomy, POPF postoperative pancreatic fistula.

Dataset Information

One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets