Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

Not Applicable

• Conditions: Pancreaticoduodenectomy
• Interventions: Procedure: Chen's U-Suture; Procedure: Classic pancreatic duct to mucosa

• Registration Number: NCT03767959
• Lead Sponsor: Chen Xiaoping

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.

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2019-06-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 960

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chen's U-Suture	Chen's U-Suture	Patients in this group will treated by Chen's U-suture technique in pancreaticojejunostomy.
Classic pancreatic duct to mucosa	Classic pancreatic duct to mucosa	Patients in this group will treated by classic pancreatic duct to mucosa technique in pancreaticojejunostomy.

Primary Outcome Measures

Name	Time	Method
Postoperative Pancreatic Fistula(POPF)	Within 30 days after surgery	POPF will be strictly classified according to IGSPF criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China