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Octreotide VS Placebo in Prevention of Salivary Fistulae After Post Radiation Salvage Surgery

NCT02437825 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-09-12

No results posted yet for this study

Summary

Salivary fistulae have been the bane of surgical salvage in the era of primary chemoradiation for head and neck (H\&N) cancers. The "blame"of prior chemoradiation tissue damage encouraged compensatory surgical techniques that focused on the insertion of non-irradiated tissue into the field. This study emphasizes a paradigm shift in the understanding and treatment of pharyngocutaneous fistulae. The detrimental effects of salivary enzymes on tissue healing and surgical anastomoses are addressed and novel treatment strategy is outlined.

Conditions

  • Fistula; Salivary Duct or Gland

Interventions

DRUG

octreotide

Octreotide has been in clinical use for thirty years and approved for use in Israel in acromegaly and functional gastroenteropancreatic tumours. It is currently being used extensively in surgical patients to prevent pancreatic fistulae1, and in lymphorrhea (both lymphatic malformations and leaks from the thoracic duct)

OTHER

placebo

placebo ( saline) act as comperator in this study.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • jeffrey weinberger, MD · hadassah MO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Israel

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 NCT02437825 on ClinicalTrials.gov