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

NCT03349424 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2020-02-13

No results posted yet for this study

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.

Conditions

  • Pancreatic Fistula

Interventions

DRUG

Somatostatin

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yupei Zhao, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2019-05-24
Completion
2019-05-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349424 on ClinicalTrials.gov