One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

Phase 3

• Conditions: Pancreatic Fistula
• Interventions: Procedure: pancreaticojejunostomy

• Registration Number: NCT02511951
• Lead Sponsor: The Second Hospital of Anhui Medical University

Brief Summary

The aim of this study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "One-layer duct-to-mucosa pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.

Detailed Description

Pancreaticoduodenectomy is a standard surgical approach for resectable pancreatic tumors and periampullary tumors. It is considered a safe procedure resulting from the continuous improvement in surgical techniques over the years. Although postoperative mortality has obviously decreased, pancreatic fistula is still a major challenge in pancreatic surgery and remains the major cause of postoperative morbidity and mortality after pancreaticoduodenectomy(PD), ranging from 3% to 30%.

Many risks factors have been shown to cause pancreatic fistula(PF) after the operation, including advanced age, prolonged operation time, intraoperative hemorrhage, BMI, soft pancreas, size of the main pancreatic duct and texture of the remnant pancreas. Among them, soft pancreatic texture without a dilated main pancreatic duct is regarded as the most important risk factor in predicting pancreatic fistula.

The serious consequences of pancreatic fistula result from the pancreatic juice becoming activated by the bile and intestinal fluid, which will eventually corrupt the PJ anastomosis and the surrounding normal tissues. The corrosion of the vasculature will lead to lethal hemorrhage, which is the main cause of mortality after pancreaticoduodenectomy. Furthermore, pancreatin, together with the bacteria in the alimentary tract, will lead to intra-abdominal infection and abscess. To reduce the pancreatic fistula rate, several techniques have been described as alternatives to the conventional PJ anastomosis. Duct-to-mucosa sutures, binding pancreaticojejunostomy and end-to-side invaginated fashion are widely used in the current clinical setting. Some non-randomized studies showed that the one-layer duct-to-mucosa method was a relatively safe approach. However, the prospective clinical study found that in comparison with the conventional two-layer duct-to-mucosa did obviously decrease the incidence of pancreatic fistula as well as other operative complications. The postoperative pancreatic fistula (POPF), which determines postoperative mortality, length of hospital stay， is dependent of its definition, and is reported in up to 16% of patients. The purpose of this study is to determine whether the new anastomosis called " one-layer duct-to-mucosa " pancreaticojejunostomy can reduce the POPF rate and downgrade compared with the common accepted duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following International Study Group on Pancreatic Fistula (ISGPF) criteria for pancreatic fistula (PF). The primary endpoint is the POPF rate, and others include overall postoperative complication rate and their severity reoperation rate and hospital stay.

Study Timeline

• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Status Verified: 2015-08
• Study Start: 2015-08
• Last Update Submitted: 2015-08-16
• Last Update Posted: 2015-08-18
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Both male and female, aged 18 to 80;
• Patients scheduled to undergo pancreaticoduodenectomy;
• Provided written informed consent;

Exclusion criteria:

• Patients with severe cardiopulmonary disorder that might prolong the postoperative hospital stay;
• Patients who had a previous pancreatic operation;
• Patients with an immunodeficiency;
• Patients who underwent an emergency operation;
• Pregnant patients.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one-layer duct-to-mucosa anastomosis	pancreaticojejunostomy	one-layer duct-to-mucosa anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
two-layer duct-to-mucosa anastomosis	pancreaticojejunostomy	two-layer duct-to-mucosa anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.

Primary Outcome Measures

Name	Time	Method
postoperative pancreatic fistula(POPF) rate	30 days	drainage of any measurable volume of fluid with an amylase content \>3 times the upper normal serum value on or after postoperative day 3.

Secondary Outcome Measures

Name	Time	Method
Duration of postoperative hospital stay	30 days	Time from day of operation to day of discharge
Morbidity	30 days	the severity of complications was graded according to the Clavien-Dindo classification
Mortality	30 days	operative mortality was defined as any death resulting from a complication during surgery
anastomosis time	1 hour	anastomosis time was calculated from begining to the end of pancreaticojejunostomy
reoperation rate	30 days	The secondary endpoint will be the reoperation rate
Biliary leakage	30	biliary leakage was documented in line with the International Study Group of Liver Surgery(ISGLS) definitions and grading systems
Blood transfusion	2 days	Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively

Trial Locations

Locations (1)

the Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China