Somatostatin Prevent Post-operation Pancreatic Fistula in Intermediate Risk Patients After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center, Randomized, Controlled Study: Somatostatin Prevent Post-operation Pancreatic Fistula (POPF) in Intermediate Risk Patients After Pancreaticoduodenectomy

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Drug: Somatostatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 year Patients underwent pancreaticoduodenectomy Fistula Risk Score recommended by ISGPS is intermediate risk Inform consent obtained Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stilamin group<br>Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin in addition to postoperative conventional treatment. | Drug: Somatostatin<br>* Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin (Stilamin®) of 250μg/h, beginning within 3 hours (Visit 1) after the operation and lasting for 120 hours (each subject will receive the Stilamin of 30mg in total), and other postoperative conventional treatment protocol remain unchanged.<br>* Other names: Stilamin;|
| No Intervention: Control group<br>Patients in the control group will receive the postoperative conventional treatment, without addition of any new medicines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative pancreatic fistula | 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. | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Somatostatin, Pancreatic Fistula, Intermediate Risk, Pancreaticoduodenectomy