Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
N/A
18 Years
80 Years
18 Years
80 Years
Open (Enrolling)
Both
Pancreatic Neoplasms, Biliary Tract Neoplasms
Both
Pancreatic Neoplasms, Biliary Tract Neoplasms
Trial Information
Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
pancreatic fistula
Outcome Description:
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
Outcome 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
Safety Issue:
Yes
Authority:
China: Ethics Committee
Study ID:
ZEH-LL-CX-004-02
NCT ID:
NCT01695447
Start Date:
January 2012
Completion Date:
December 2014
Related Keywords:
- Pancreatic Neoplasms
- Biliary Tract Neoplasms
- Biliary Tract Neoplasms
- Neoplasms
- Pancreatic Neoplasms
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