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

• Status: Completed
• Trial end date: 2019-05-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Somatostatin

Criteria

Inclusion Criteria:

1. Age ≥ 18 year

2. Patients underwent pancreaticoduodenectomy

3. Fistula Risk Score recommended by ISGPS is intermediate risk

4. Inform consent obtained

Exclusion Criteria:

1. Pervious pancreatic surgery history

2. Received somatostatin or analogues treatment less than 5 half-life periods before surgery

3. Known allergy to somatostatin or mannitol

4. Woman who is pregnant, plan to be pregnant or during lactation period

5. Attended other clinical trials within 30 days

6. All contraindications to somatostatin (Stilamin®)

7. Patients with any serious disease that investigator considers he/she should be excluded