Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

NCT03767959 | Unknown DMC

• 1 other identifier: C201811
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative Pancreatic Fistula(POPF)

  POPF will be strictly classified according to IGSPF criteria

  Within 30 days after surgery

Secondary Outcomes (8)

• Duration of operation

  Intraoperative

• Grade of POPF

  Within 30 days after surgery

• Morbidity

  Within 90 days after surgery

• Mortality

  Within 30 days after surgery

• Length of hospital stay after surgery

  From first day after surgery to release from hospital (anticipate 5 days minimally)

Study Arms (2)

Chen's U-Suture

EXPERIMENTAL

Patients in this group will treated by Chen's U-suture technique in pancreaticojejunostomy.

Procedure: Chen's U-Suture

Classic pancreatic duct to mucosa

ACTIVE COMPARATOR

Patients in this group will treated by classic pancreatic duct to mucosa technique in pancreaticojejunostomy.

Procedure: Classic pancreatic duct to mucosa

Interventions

Chen's U-Suture PROCEDURE

Chen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures

Chen's U-Suture

Classic pancreatic duct to mucosa PROCEDURE

A Classical anastomosis technique for Pancreaticojejunostomy

Classic pancreatic duct to mucosa

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Study Officials

• Xiaoping Chen

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoping Chen

CONTACT

86-027-83663400; chenxp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: December 7, 2018
• Study Start: June 24, 2019
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

CN (1)