Recruiting

Gastric Pull Up vs. Free Flap

Sponsor:

University of British Columbia

Code:

NCT03171558

Conditions

Head and Neck Neoplasms

Pharyngectomy

Reconstructive Surgical Procedures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gastric Pull Up

Free Flap Surgery

Study Details

Brief 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

Study ID

NCT03171558

Start date

Mar 16, 2017

Status verified date

May, 2017

Completion date

Mar, 2023

Anticipated

Primary completion date

Mar, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willing to provide informed consent, attend follow-up visits and complete questionnaires
  • Have an Eastern Cooperation Oncology Group (ECOG) performance status of 0-2
  • Patients with carcinoma of thyroid, larynx, hypopharynx, or cervical esophagus requiring surgery as a primary treatment modality or after chemoradiation treatment failure
  • Laryngectomy and circumferential pharyngectomy as recommended by the head and neck tumor board

Exclusion Criteria:

  • Serious medical co morbidities or other contraindications to surgery
  • Metastatic disease
  • Pregnant or lactating women
  • Patients whose clinical circumstances are such that one surgical intervention would be recommended over the other: The cancer extends into the the thorax as seen on pre-operative CT scan. In these patients, the GPU reconstruction is preferred.
  • Patients who have liver cirrhosis or multiple previous surgeries on the stomach would not be candidates for the GPU and thus will be excluded from the study

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gastric Pull Up

Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect.

active comparator: Free Flap

Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect.

Interventions

Gastric Pull Up

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

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.

Primary outcome measure

  • Type and number of postoperative complications [ Time Frame: Within 90 days of surgery occurring on the same or separate admission. ]

Central Contacts and Locations

Central contacts

Prisman Eitan, MD, FRCSC

604-875-4126eitan.prisman@gmail.com

Oleksandr Butskiy, MD

604-375-7529butskiy.alex@gmail.com

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Eitan Prisman, MD

604.875.4126eitan.prisman@gmail.com

More Information

Sponsor

University of British Columbia

Last update posted

May 31, 2017

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2017-05-31.