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

Study Overview
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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.

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

Conditions
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Head and Neck Neoplasms, Pharyngectomy, Reconstructive Surgical Procedures

Intervention / Treatment
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* Procedure: Gastric Pull Up
* Procedure: Free Flap Surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Time | Time from first incision to the end of surgical closure as documented on the nursing record. | Initial Surgery | 
| Operative blood loss | 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 | Requirement for transfusion, measured in units of blood. | During initial surgery and within the first 72 hours. | 
| Flap Donor Site Morbidity (RFFF) ) | 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) | 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 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 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. | Whether patients are still feeding tube dependent for nutrition at 1 year follow up. | Documented at 1 year follow up visit. | 
| Voice Function | 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 | 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 | 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 | 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 | 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 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 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 from the date of the surgery until a patient shows sign of disease progression | Patients will be monitored for 5 years post-operatively |