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

NCT ID: NCT03171558

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Neoplasms Pharyngectomy Reconstructive Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastric Pull Up

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

Group Type EXPERIMENTAL

Gastric Pull Up

Intervention Type PROCEDURE

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

Free Flap

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

Group Type ACTIVE_COMPARATOR

Free Flap Surgery

Intervention Type PROCEDURE

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

Interventions

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Gastric Pull Up

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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Anterolateral thigh free flap and radial forearm free flap

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Eitan Prisman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prisman Eitan, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Prisman Eitan, MD, FRCSC

Role: CONTACT

Phone: 604-875-4126

Email: [email protected]

Oleksandr Butskiy, MD

Role: CONTACT

Phone: 604-375-7529

Email: [email protected]

Facility Contacts

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Eitan Prisman, MD

Role: primary

Other Identifiers

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H14-00004

Identifier Type: -

Identifier Source: org_study_id