CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 114 enrolled
Drug / intervention
Lanreotide Prefilled Syringedrug
Likely dose
Lanreotide Prefilled Syringe 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03174353
NCT03174353Phase 2Completed

A Phase II Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

University of Washington·interventional·Posted Jun 2, 2017·Updated Jun 16, 2022

In Brief

A Phase 2 clinical trial evaluating Lanreotide Prefilled Syringe for Pancreatic Leak and 3 related conditions. Completed, enrolled 114 participants across 1 site.

Detailed Summary

This is a single arm investigator-initiated study designed to test the feasibility and potential efficacy of preoperative lanreotide to reduce the risk of postoperative abscess or pancreatic leak and fistula. All consenting patients undergoing planned elective pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy will be treated with a single deep subcutaneous dose of lanreotide prior to planned resection on the day of surgery. Following this intervention, care will be based on standard treatment protocols. Sixty-day mortality and morbidity will be collected for all patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 2, 2017
Enrollment StartFeb 20, 2018
Primary CompletionFeb 1, 2021
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.1 years ago

Interventions

Lanreotide Prefilled Syringedrug

All patients enrolled in this study will receive SOMATULINE DEPOT 120 mg immediately prior to planned pancreatic resection. The pharmacist will dispense loaded syringes of the study drug. The single preoperative dose will be given in the pre-surgical center at the University of Washington by a trained health care professional. The study drug will be injected via the deep subcutaneous route in the superior external quadrant of the buttock.