Status:
UNKNOWN
Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy
Lead Sponsor:
Chen Xiaoping
Conditions:
Pancreaticoduodenectomy
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT03767959
Start Date
June 24 2019
End Date
July 1 2021
Last Update
March 4 2020
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030