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

NCT03171558 | Unknown

• 1 other identifier: H14-00004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Type and number of postoperative complications

  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 Outcomes (16)

• Surgical Time

  Initial Surgery

• Operative blood loss

  Initial surgery

• Operative Parameters

  During initial surgery and within the first 72 hours.

• Flap Donor Site Morbidity (RFFF) )

  Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)

• Flap Donor Site Morbidity (ALT)

  Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)

Study Arms (2)

Gastric Pull Up

EXPERIMENTAL

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

Procedure: Gastric Pull Up

Free Flap

ACTIVE COMPARATOR

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

Procedure: Free Flap Surgery

Interventions

Gastric Pull Up PROCEDURE

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

Gastric Pull Up

Free Flap Surgery PROCEDURE

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

Also known as: Anterolateral thigh free flap and radial forearm free flap

Free Flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Prisman Eitan, MD, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prisman Eitan, MD, FRCSC

CONTACT

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

Oleksandr Butskiy, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: May 31, 2017
• Study Start: March 16, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)