Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects (GPU vs ALT)

University of British Columbia

Status: Unknown

Conditions: Pharyngectomy; Reconstructive Surgical Procedures; Head and Neck Neoplasms

Treatments: Procedure: Gastric Pull Up; Procedure: Free Flap Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03171558

H14-00004

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Gastric Pull Up

Experimental group

Description:

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

Treatment:

Procedure: Gastric Pull Up

Free Flap

Active Comparator group

Description:

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

Treatment:

Procedure: Free Flap Surgery