NCT03314337CompletedNot Applicable
A Prospective Randomized Controlled Study Comparing Outcomes of Distal Pancreatectomy With or Without Pancreatic Stent
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ruijin Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- all-cause mortality / complications
Study Overview
Brief Summary
The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy with or without pancreatic stent
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing distal pancreatectomy
- •Signed the informed consents
Exclusion Criteria
- •Recurrence patients
- •pre-operative anti-cancer treatment
- •patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
- •AJCC stage IV
- •pre operative oddi'ssphincter incision
- •operation non radical
- •pancreatic stent not at place
Outcomes
Primary Outcomes
all-cause mortality / complications
Time Frame: Hospitalization 30days（duration of hospital stay)
mortality, pancreatic fistula, Biliary fistula，bleeding， etc
Secondary Outcomes
- all-cause mortality / complications(30 days after operation)
Investigators
Weishen WANG
doctor
Ruijin Hospital
Study Sites (1)
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