Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- pancreatic fistula
Study Overview
Brief Summary
The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
- •18 to 80 y/o
- •Operation-tolerated
- •Informed consent
Exclusion Criteria
- •History of gastrointestinal operation
- •Pancreaticoduodenectomy is given up during operation
- •Pancreatic duct is difficult to locate
- •Patients require to exit from the study anytime
Outcomes
Primary Outcomes
pancreatic fistula
Time Frame: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
Secondary Outcomes
- Mortality(From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days)
- Morbidity(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
- Reoperation(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
- Hospital stay(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
Investigators
TingBo Liang
The Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
Zhejiang University