Somatostatin Prevent Post-operation Pancreatic Fistula in Intermediate Risk Patients After Pancreaticoduodenectomy
- Registration Number
- NCT03349424
- Lead Sponsor
- Peking Union Medical College Hospital
- 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 treatment group will be continuous intravenous infusion with the somatostatin (Stilamin®) in addition to conventional treatments (including infection prevention, nutrition support and acid suppression therapy, etc.).The pancreatic fistula incidence will be monitored within 30 days after operation.
- 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 the inclusion and exclusion criteria after PD and subjects meeting the standard are assigned randomly to the treatment group or control group. Apart from conventional treatments (including infection prevention, nutrition support and acid suppression therapy, etc.), the treatment group will be continuous intravenous infusion with the somatostatin (Stilamin®) of 250μg/h for 120h (total dose of 6mg/day x 5 days=30mg), beginning within 3 hours after the operation; the control group will accept conventional treatments other than the Stilamin.
The pancreatic fistula incidence, biochemical leak incidence, morbidity and number of other complications related to the pancreatectomy, length of stay in hospital, hospitalization cost, re-admission rate and re-operation rate will be monitored within 30 days after operation. Subjects will be visited for 5 times from the start to the end of the study.
Statistical Methods:Number of patients who had pancreatic fistula after surgery will be analyzed using Chi-square test.Secondary endpoints: Continuous variates will be described as mean± SD; attempted to be analyzed using analysis of variance. Categorical variates will be described as rate; attempted to be analyzed using Chi-square test.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
- Age ≥ 18 year
- Patients underwent pancreaticoduodenectomy
- Fistula Risk Score recommended by ISGPS is intermediate risk
- Inform consent obtained
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stilamin group Somatostatin Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin in addition to postoperative conventional treatment.
- Primary Outcome Measures
Name Time Method Incidence of post-operative pancreatic fistula 30 days after operation A clinically relevant postoperative pancreatic fistula is now defined as a drain output of any measurable volume of fluid with an amylase level \>3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China