Clinical trial NCT03171558: Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects
Official title: Gastric Pull up Versus Free Flaps Reconstruction (Anterolateral Thigh and Radial Forearm Free Flap) for Laryngo-pharyngeal Defects: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Neoplasms
Pharyngectomy
Reconstructive Surgical Procedures
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Type and number of postoperative complications
timeFrame: Within 90 days of surgery occurring on the same or separate admission.
Secondary outcomes:
measure: Surgical Time
timeFrame: Initial Surgery
measure: Operative blood loss
timeFrame: Initial surgery
measure: Operative Parameters
timeFrame: During initial surgery and within the first 72 hours.
measure: Flap Donor Site Morbidity (RFFF) )
timeFrame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
measure: Flap Donor Site Morbidity (ALT)
timeFrame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
measure: Time to return to swallowing
timeFrame: 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)
measure: Time to return of FULL oral diet
timeFrame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
measure: Requirement for feeding tube at 1 year after surgery.
timeFrame: Documented at 1 year follow up visit.
measure: Voice Function
timeFrame: 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)
measure: Dysphagia
timeFrame: 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)
measure: Dumping Symptoms
timeFrame: 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)
measure: Quality of Life
timeFrame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
measure: Margin status of the resected specimen as reported by pathology
timeFrame: At the time of surgery
measure: Time to progression
timeFrame: Patients will be monitored for 5 years post-operatively
measure: Disease Free Survival
timeFrame: Patients will be monitored for 5 years post-operatively
measure: Progression-free survival
timeFrame: Patients will be monitored for 5 years post-operatively
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Prisman Eitan, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: