Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

Evaluation of Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for malignant neoplasms located in the peri-ampullary region, and is increasingly being used for the treatment of cancer through the resection of the premalignant precursors for invasive carcinomas.Postoperative pancreatic fistula (POPF) is one of the most common complications associated with substantial clinical implications following PD, which significantly affects mortality rate, length of hospital stay, and overall hospital costs. Therefore, the prevention of POPF has always been a high priority for our group as well as other international surgical groups. In 1995, investigators' group established the Chen's U-stitch approach, which was a new technique of end-to-end invaginated pancreaticojejunostomy with transpancreatic transverse U-sutures after PD, and the preliminary results were quite encouraging at that time. Thus, investigators intend to conduct a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of the new technique.

Study Overview

• Status: Unknown
• Conditions: Pancreaticoduodenectomy
• Intervention / Treatment: Procedure: Chen's U-Suture; Procedure: Classic pancreatic duct to mucosa

Detailed Description

This is a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of Chen's U-Suture technique for pancreaticojejunostomy following pancreaticoduodenectomy. Investigators plan to enroll 960 patients in this study and eligible patients will be randomly divided into two groups. One group will use Chen's U-Suture technique and other group will use classic duct-to-mucosa technique. All patients will be followed up for 3 month after surgery, and primary outcome is POPF, other outcome such as duration of operation, grade of POPF, morbidity, mortality, length of hospital stay, reoperation rate, postoperative pancreatic function and postoperative incidence of chronic pancreatic diseases.

• Study Type: Interventional
• Enrollment (Anticipated): 960
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoping Chen; Phone Number: 86-027-83663400; Email: chenxp@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xiaoping Chen; Email: chenxp@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, 18 to 75 years of age, inclusive.
2. Patients have a diagnosis of benign and malignant diseases of the pancreatic head and periampullary region and requiring pancreaticoduodenectomy.
3. Patients have not been treated with any anticancer medications and immunotherapy prior to surgery
4. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.
2. Patients scheduled to undergo pancreatogastrostomy.
3. Patients whose pancreatic duct cannot be located.
4. Patients with history of previous pancreatic surgery, server acute or chronic disease or surgical contraindication.
5. Patients with HIV-infectious or other AIDS-related disease.
6. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chen's U-Suture; Patients in this group will treated by Chen's U-suture technique in pancreaticojejunostomy.	Procedure: Chen's U-Suture; Chen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures
ACTIVE_COMPARATOR: Classic pancreatic duct to mucosa; Patients in this group will treated by classic pancreatic duct to mucosa technique in pancreaticojejunostomy.	Procedure: Classic pancreatic duct to mucosa; A Classical anastomosis technique for Pancreaticojejunostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pancreatic Fistula(POPF)	POPF will be strictly classified according to IGSPF criteria	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of operation	The time of operation count by minute.	Intraoperative
Grade of POPF	The grade of POPF will be strictly classified according to IGSPF criteria	Within 30 days after surgery
Morbidity	The incidence of operative complications within 90 days after surgery.	Within 90 days after surgery
Mortality	The death occurred within 30 days after surgery	Within 30 days after surgery
Length of hospital stay after surgery	Days between surgery and hospital discharge	From first day after surgery to release from hospital (anticipate 5 days minimally)
Reoperation rate	The incidence of reoperation within 1 year after surgery.	Within one year after surgery
Postoperative pancreatic function	Postoperative pancreatic function such as blood glucose, blood diastasum diastace, urine amylase, etc.	Within one year after surgery
Postoperative incidence of chronic pancreatic diseases	The incidence of chronic pancreatic diseases, the chronic pancreatic diseases include chronic pancreatitis.	Within one year after surgery

Collaborators and Investigators

• Sponsor: Chen Xiaoping

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2019
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (ACTUAL): December 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: C201811

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No