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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 4

Conditions: Pancreatic Fistula

Treatments: Drug: Somatostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03349424

MS200115_0006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

Stilamin group

Experimental group

Description:

Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin in addition to postoperative conventional treatment.

Treatment:

Drug: Somatostatin

Control group

No Intervention group

Description:

Patients in the control group will receive the postoperative conventional treatment, without addition of any new medicines.