Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

NCT ID: NCT03767959

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 960 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2021-07-31

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.

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.

Conditions

Pancreaticoduodenectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chen's U-Suture

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

Group Type: EXPERIMENTAL

Chen's U-Suture

Intervention Type: PROCEDURE

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

Classic pancreatic duct to mucosa

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

Group Type: ACTIVE_COMPARATOR

Classic pancreatic duct to mucosa

Intervention Type: PROCEDURE

A Classical anastomosis technique for Pancreaticojejunostomy

Interventions

Chen's U-Suture

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

Intervention Type: PROCEDURE

Classic pancreatic duct to mucosa

A Classical anastomosis technique for Pancreaticojejunostomy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chen Xiaoping

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaoping

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaoping Chen

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoping Chen

Role: CONTACT

chenxp@163.com

86-027-83663400

Facility Contacts

Xiaoping Chen

Role: primary

chenxp@163.com

Other Identifiers

C201811

Identifier Type: -

Identifier Source: org_study_id