Status:
COMPLETED
Somatostatin Prevent Post-operation Pancreatic Fistula in Intermediate Risk Patients After Pancreaticoduodenectomy
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Pancreatic Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to assess the preventive effects of somatostatin on post-operation pancreatic fistula in intermediate risk patients after pancreaticoduodenectomy. Patients assigned into the tre...
Detailed Description
This is a multi-center randomized, controlled clinical trial. A total of 200 patients are expected to be recruited. Each trial center recruits subjects based on the sequential principle and inspect th...
Eligibility Criteria
Inclusion
- Age ≥ 18 year
- Patients underwent pancreaticoduodenectomy
- Fistula Risk Score recommended by ISGPS is intermediate risk
- Inform consent obtained
Exclusion
- Pervious pancreatic surgery history
- Received somatostatin or analogues treatment less than 5 half-life periods before surgery
- Known allergy to somatostatin or mannitol
- Woman who is pregnant, plan to be pregnant or during lactation period
- Attended other clinical trials within 30 days
- All contraindications to somatostatin (Stilamin®)
- Patients with any serious disease that investigator considers he/she should be excluded
Key Trial Info
Start Date :
June 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2019
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT03349424
Start Date
June 22 2018
End Date
May 24 2019
Last Update
February 13 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730