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

May 30, 2017 updated by: Eitan Prisman, University of British Columbia

Gastric Pull up Versus Free Flaps Reconstruction (Anterolateral Thigh and Radial Forearm Free Flap) for Laryngo-pharyngeal Defects: A Prospective Randomized Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastric Pull Up
Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect.
Procedure: Gastric Pull Up
Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.
Active Comparator: Free Flap
Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect.
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.
Other Names:
  • Anterolateral thigh free flap and radial forearm free flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type and number of postoperative complications
Time Frame: Within 90 days of surgery occurring on the same or separate admission.
Complications will be divided by: (1) in-hospital mortality (2) reconstruction related complications (anastomotic leak, fistula formation, flap necrosis, flap stenosis or stricture, requirement for surgical revision), and (3) addition in-hospital complications ( bleeding, pulmonary, cardiac, infectious, abdominal, wound concern)
Within 90 days of surgery occurring on the same or separate admission.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Time
Time Frame: Initial Surgery
Time from first incision to the end of surgical closure as documented on the nursing record.
Initial Surgery
Operative blood loss
Time Frame: Initial surgery
Total volume of blood lost and accounted for in suction canisters as documented in nursing charts. (this excludes blood not accounted for in the suction containers)
Initial surgery
Operative Parameters
Time Frame: During initial surgery and within the first 72 hours.
Requirement for transfusion, measured in units of blood.
During initial surgery and within the first 72 hours.
Flap Donor Site Morbidity (RFFF) )
Time Frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Donor site associated quality of life (Toronto Extremity Salvage Score - Upper Extremity)
Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Flap Donor Site Morbidity (ALT)
Time Frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Donor site associated quality of life (Toronto Extremity Salvage Score - Lower Extremity)
Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Time to return to swallowing
Time Frame: If occurs in hospital will be documented by the treating team. Otherwise will be documented based on patient or speech language pathology reporting at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Time from surgery to swallowing liquids.
If occurs in hospital will be documented by the treating team. Otherwise will be documented based on patient or speech language pathology reporting at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Time to return of FULL oral diet
Time Frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Time from surgery to return of diet that is sufficient for patient to maintain nutrition without requiring G-tube or NG feeding. Patient or Speech Language Pathology reported.
Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Requirement for feeding tube at 1 year after surgery.
Time Frame: Documented at 1 year follow up visit.
Whether patients are still feeding tube dependent for nutrition at 1 year follow up.
Documented at 1 year follow up visit.
Voice Function
Time Frame: Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Measured by Voice Handicap Index -10
Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Dysphagia
Time Frame: Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
M.D. Anderson Dysphagia Inventory for assessment of dysphagia
Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Dumping Symptoms
Time Frame: Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Assessed with the dumping symptom rating scale
Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Quality of Life
Time Frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Measure with combined scores of two questionnaires: European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ) - C30 and EORTC QLQ - H&N35
Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Margin status of the resected specimen as reported by pathology
Time Frame: At the time of surgery
Will be classified as positive and negative based on what is reported at Vancouver General Hospital Pathology reports generated at the time of surgery. A measure of clearance in millimeters will also be provided.
At the time of surgery
Time to progression
Time Frame: Patients will be monitored for 5 years post-operatively
time from the date of the surgery until local, regional, or metastatic disease is detected
Patients will be monitored for 5 years post-operatively
Disease Free Survival
Time Frame: Patients will be monitored for 5 years post-operatively
Time from the date of the surgery until a patient experiences a recurrence, a new primary cancer or death
Patients will be monitored for 5 years post-operatively
Progression-free survival
Time Frame: Patients will be monitored for 5 years post-operatively
Time from the date of the surgery until a patient shows sign of disease progression
Patients will be monitored for 5 years post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Prisman Eitan, MD, FRCSC, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2017

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-00004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Neoplasms

Clinical Trials on Gastric Pull Up

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe