Different Pancreaticojejunostomy After Pancreaticoduodenectomy

July 24, 2022 updated by: Junjie Xiong

A Prospective Randomized Controlled Trial of the Effect of Different Pancreaticojejunostomy After Pancreaticoduodenectomy on Postoperative Pancreatic Fistula Based on the Position of the Pancreatic Duct in Pancreatic Section

The aim of this study was to reduce the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy by using different pancreaticojejunostomy methods according to the position of the pancreatic duct.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatectomy, especially pancreaticoduodenectomy, is the most complicated surgical approach in all abdominal surgeries. Postoperative pancreatic fistula (POPF) is the most serious complication after pancreaticoduodenectomy. Once it occurs, it will affect postoperative recovery, increase abdominal infection, and even lead to postoperative hemorrhage and life-threatening conditions. The quality of pancreaticojejunostomy has an inevitable relationship with postoperative pancreatic fistula. At present, there are many studies based on the risk factors for pancreatic fistula, including the texture of the pancreas, the diameter of the pancreatic duct, the patient's general condition and other factors, but little attention has been given to the position of the pancreatic duct in the residual pancreatic section. At present, the choice of pancreaticojejunostomy is more arbitrary. Although duct-to-mucosa pancreaticojejunostomy has become mainstream, there are still great differences. At present, there is no pancreaticojejunostomy that can completely avoid the occurrence of pancreatic fistula. The investigators found that the anatomical position of the pancreatic duct in pancreatic section was very important in pancreaticoduodenectomy and divided them into the central type and eccentric type. It was initially found that the incidence of pancreatic fistula after an eccentric pancreatic duct was significantly increased. It was confirmed that the anatomical position of the pancreatic duct is related to the occurrence of POPF. On this basis, the investigators proposed that different types of pancreatic ducts using different anastomosis methods, which may reduce the incidence of POPF. The study data come from the Department of Pancreatic Surgery, West China Hospital, Sichuan University, and the sample size is estimated from the number of patients admitted to the Department of Pancreatic Surgery in the past two years according to the POPF rate. The participants were randomly divided into the experimental group and the control group. The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was <0.401, it was divided into the N2 group (eccentric pancreatic duct). The "central pancreatic duct" group was given "1+1 mode" pancreaticojejunostomy; the "eccentric pancreatic duct" group was given "1+1² mode" pancreaticojejunostomy. The patients in the control group were given "traditional pancreaticojejunostomy". The preoperative basic conditions and postoperative clinically relevant pancreatic fistula and other complications were compared between the two groups. This is expected to be confirmed by the investigators basing on the different types of pancreatic ducts, and the corresponding pancreaticojejunostomy can reduce the incidence of postoperative pancreatic fistula in patients undergoing pancreaticoduodenectomy. The primary outcome was the rate of POPF, and the secondary outcomes included postoperative hemorrhage, postoperative biliary fistula, delayed gastric emptying and so on. Preoperative baseline characteristic data were collected, including age, sex, BMI, ASA, preoperative serum protein level, preoperative blood total bilirubin level, and so on. The postoperative complications and recovery data were collected.

Study Type

Interventional

Enrollment (Anticipated)

924

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Bole Tian
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lang Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of benign or malignant peri-ampullary diseases
  • The participants have age more than18 years
  • The participants have adequate organ function to tolerate surgery

Exclusion Criteria:

*The participants undergoing other organ surgery at the same time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was <0.401, it was divided into the N2 group (eccentric pancreatic duct). The "central pancreatic duct" group was given "1+1 mode" pancreaticojejunostomy; the "eccentric pancreatic duct" group was given "1+1² mode" pancreaticojejunostomy.
Procedure: pancreaticojejunostomy
The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was <0.401, it was divided into the N2 group (eccentric pancreatic duct). The "central pancreatic duct" group was given "1+1 mode" pancreaticojejunostomy; the "eccentric pancreatic duct" group was given "1+1² mode" pancreaticojejunostomy.
Active Comparator: Control group
The patients in the control group were given "traditional pancreaticojejunostomy"
Procedure: pancreaticojejunostomy
The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was <0.401, it was divided into the N2 group (eccentric pancreatic duct). The "central pancreatic duct" group was given "1+1 mode" pancreaticojejunostomy; the "eccentric pancreatic duct" group was given "1+1² mode" pancreaticojejunostomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pancreatic fistula(POPF) as assessed by 2016 ISGPS definition
Time Frame: Within 30 days
2016 ISGPS definition(POPF):A drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.
Within 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hemorrhage as assessed by ISGPS definition
Time Frame: Within 30 days
Postoperative hemorrhage(ISGPS definition):definition of PPH is based on three parameters: time of onset, location, and severity of hemorrhage: (1)Onset is either early (≤24 hours after end of the index operation) or late (>24 hours); (2) Location is either intraluminal (eg,pancreatic surface, anastomoses, gastric/duodenal ulcer/erosion, or hemobilia) or extraluminal (eg, arterial or venous vessel, operating field, external suture or staple line, or pseudoaneurysm); (3) Severity of bleeding may be mild or severe.
Within 30 days
Delayed gastric emptying as assessed by ISGPS definition
Time Frame: Within 30 days
Delayed gastric emptying(ISGPS definition):Delayed gastric emptying represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A, B, and C) were defined based on the impact on the clinical course and on postoperative management.
Within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Junjie Xiong

Investigators

  • Study Chair: Bole Tian, MD, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 24, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022(148)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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