Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreaticoduodenectomy

Intervention / Treatment
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* Procedure: Chen's U-Suture
* Procedure: Classic pancreatic duct to mucosa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chen's U-Suture<br>Patients in this group will treated by Chen's U-suture technique in pancreaticojejunostomy. | Procedure: Chen's U-Suture<br>* Chen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures<br>|
| Active Comparator: Classic pancreatic duct to mucosa<br>Patients in this group will treated by classic pancreatic duct to mucosa technique in pancreaticojejunostomy. | Procedure: Classic pancreatic duct to mucosa<br>* A Classical anastomosis technique for Pancreaticojejunostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pancreatic Fistula(POPF) | POPF will be strictly classified according to IGSPF criteria | Within 30 days after surgery | 

Secondary Outcome Measures

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