MedTrace Logo

Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects

NCT03171558 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-05-31

No results posted yet for this study

Summary

This study will compare the gastric pull up (GPU) with the free flap \[(specifically, anterolateral thigh (ALT) and radial forearm free flap (RFFF)\] techniques used in the reconstruction of alimentary tracts in patients who require laryngectomy and circumferential pharyngectomy for carcinoma resection. These two interventions will be compared by block randomizing 20 patients based on history of failed chemoradiation to undergo either ALT or RFFF. The primary outcome will be the type and number of postoperative complications. The secondary outcomes will include swallowing function, speech, and quality of life measures along with cancer specific endpoints.

Conditions

  • Head and Neck Neoplasms
  • Pharyngectomy
  • Reconstructive Surgical Procedures

Interventions

PROCEDURE

Gastric Pull Up

Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.

PROCEDURE

Free Flap Surgery

Using radial forearm free flap or anterolateral thigh free flap to reconstruct the cervical esophagus and pharynx after pharyngectomy and cervical esophagectomy.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Prisman Eitan, MD, FRCSC · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2022-03-31
Completion
2023-03-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT03171558 on ClinicalTrials.gov