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

NCT03174353 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2022-06-16

Study results available
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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.

Conditions

  • Pancreatic Leak
  • Pancreatic Fistula
  • Pancreaticoduodenal; Fistula
  • Pancreatectomy; Hyperglycemia

Interventions

DRUG

Lanreotide Prefilled Syringe

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.

Sponsors & Collaborators

Principal Investigators

  • Venu G Pillarisetty, MD · University of Washington

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-20
Primary Completion
2021-02-01
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03174353 on ClinicalTrials.gov