Clinical trial NCT03767959: Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy
Official title: Evaluation of Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreaticoduodenectomy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative Pancreatic Fistula(POPF)
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Duration of operation
timeFrame: Intraoperative
measure: Grade of POPF
timeFrame: Within 30 days after surgery
measure: Morbidity
timeFrame: Within 90 days after surgery
measure: Mortality
timeFrame: Within 30 days after surgery
measure: Length of hospital stay after surgery
timeFrame: From first day after surgery to release from hospital (anticipate 5 days minimally)
measure: Reoperation rate
timeFrame: Within one year after surgery
measure: Postoperative pancreatic function
timeFrame: Within one year after surgery
measure: Postoperative incidence of chronic pancreatic diseases
timeFrame: Within one year after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiaoping Chen
role: PRINCIPAL_INVESTIGATOR
References: