Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03767959
• Other study ID #: C201811
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: July 2021

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: Xiaoping Chen
• Phone: 86-027-83663400
• Email: chenxp[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

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
• Classic pancreatic duct to mucosa
A Classical anastomosis technique for Pancreaticojejunostomy

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chen Xiaoping

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pancreatic Fistula(POPF)	POPF will be strictly classified according to IGSPF criteria	Within 30 days after surgery
Secondary	Duration of operation	The time of operation count by minute.	Intraoperative
Secondary	Grade of POPF	The grade of POPF will be strictly classified according to IGSPF criteria	Within 30 days after surgery
Secondary	Morbidity	The incidence of operative complications within 90 days after surgery.	Within 90 days after surgery
Secondary	Mortality	The death occurred within 30 days after surgery	Within 30 days after surgery
Secondary	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)
Secondary	Reoperation rate	The incidence of reoperation within 1 year after surgery.	Within one year after surgery
Secondary	Postoperative pancreatic function	Postoperative pancreatic function such as blood glucose, blood diastasum diastace, urine amylase, etc.	Within one year after surgery
Secondary	Postoperative incidence of chronic pancreatic diseases	The incidence of chronic pancreatic diseases, the chronic pancreatic diseases include chronic pancreatitis.	Within one year after surgery