Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy

The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy

Study Overview

• Status: Unknown
• Conditions: Pancreatic Fistula
• Intervention / Treatment: Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy; Procedure: Invagination pancreaticojejunostomy

Detailed Description

Duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy, with comparable incidence rate of pancreatic fistula (PF). We modified the conventional two-layer duct-to-mucosa PJ into one-layer PJ. The aim of this study is to examine if the investigator's modified duct-to-mucosa PJ can reduce PF after PD when compared to invagination PJ.

This trial is a single-center, randomized, controlled, patient- and observer- blinded study, whose primary aim is to assess whether a modified duct-to-mucosa PJ (trial group) is superior to an invagination PJ (control group), in terms of clinically relevant PF and other complications. A total of 380 patients, who are to undergo elective PD, will be recruited and randomized intraoperatively into either of the two groups. The primary efficacy endpoint is the incident rate of clinically relevant PF. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay. Patients will be followed up for 3 months. Statistical analysis will be based on the intention-to-treat population. The duration of the entire trial is estimated to be two years.

• Study Type: Interventional
• Enrollment (Anticipated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jishu Wei, M.D.; Phone Number: 86-25-68136891; Email: weijishu@njmu.edu.cn

Study Locations

• China
  • Nanjing, China, 210029
    • The First Affiliated Hospital of Nanjing Medical University
    • Contact: Yi Miao, PhD; Email: miaoyi@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written Informed consent obtained；
• Both sexes between 18 and 80 years old；
• Patients scheduled to elective open pancreaticoduodenectomy.

Exclusion Criteria:

• Patients with ASA score >=4;
• Patients who had a previous pancreatic operation;
• Patients with an immunodeficiency;
• Patients who underwent an emergency operation;
• Pregnant patients；
• Patients who was found that pancreaticoduodenectomy was not suitable。

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One-layer duct-to-mucosa Group; Modified one-layer duct-to-mucosa pancreaticojejunostomy is used after pancreaticoduodenectomy.	Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy; After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.
Active Comparator: Invagination Group; Invagination pancreaticojejunostomy is used after pancreaticoduodenectomy.	Procedure: Invagination pancreaticojejunostomy; After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinically relevant postoperative pancreatic fistula (POPF)	As defined by International Study Group on Pancreatic Fistula, a clinically relevant postoperative pancreatic fistula is now redefined as 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.	Up to 60 days after Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomosis time	Time from the beginning to the end of the pancreatic reconstruction	intraoperatively
Delayed gastric emptying	The International Study Group for Pancreatic Surgery definition and classification of delayed gastric emptying were applied. Briefly, grade A, unable to tolerate solid oral intake by POD 7 and usually no vomiting; grade B, unable to tolerate solid oral intake by POD 14 with/without vomiting: and grade C, unable to tolerate solid oral intake by POD 21 with/without vomiting.	Up to 60 day after Surgery
post-pancreatectomy hemorrhage (PPH)	The 2017 International Study Group for Pancreatic Surgery definition and classification of PPH were applied.	Up to 60 days after Surgery
Chyle leak	The 2017 International Study Group for Pancreatic Surgery definition and classification of chyle leak were applied.	Up to 60 days after Surgery
Overall Morbidity	Any complications that occur postoperatively. The severity of complications was graded according to the Clavien-Dindo classification.	Up to 60 days after Surgery
Mortality	Patient death that occurs postoperatively	Up to 90 days after Surgery
Reoperation rate	Patients who needs a surgical re-operation for any reasons during the postoperative hosptial stay. Reasons and times of reoperation are recorded.	Up to 90 days after Surgery
Readmission rate	Patients that readmitted into hospital for reasons that related to complications of last pancreatic surgery.	Up to 60 days after Surgery
Duration of postoperative hospital stay	Time from day of operation to day of discharge	Up to 90 days after Surgery

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Study Director: Miao, Prof., Nanjing Medical University

Publications and helpful links

General Publications

• Wei J, Liu X, Wu J, Xu W, Zhou J, Lu Z, Chen J, Guo F, Gao W, Li Q, Jiang K, Dai C, Miao Y. Modified One-layer Duct-to-mucosa Pancreaticojejunostomy Reduces Pancreatic Fistula After Pancreaticoduodenectomy. Int Surg. 2015 Jun 3. doi: 10.9738/INTSURG-D-15-00094.1. Online ahead of print.
• Hai H, Li Z, Zhang Z, Cheng Y, Liu Z, Gong J, Deng Y. Duct-to-mucosa versus other types of pancreaticojejunostomy for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD013462. doi: 10.1002/14651858.CD013462.pub2.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: JSPH-PC-201801

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