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

Not Applicable

• Conditions: Reconstructive Surgical Procedures; Head and Neck Neoplasms; Pharyngectomy
• Interventions: Procedure: Gastric Pull Up; Procedure: Free Flap Surgery

• Registration Number: NCT03171558
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-22
• Study Start: 2017-03-16
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Study First Posted: 2017-05-31
• Last Update Posted: 2017-05-31
• Primary Completion: 2022-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastric Pull Up	Gastric Pull Up	Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect.
Free Flap	Free Flap Surgery	Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect.

Primary Outcome Measures

Name	Time	Method
Type and number of postoperative complications	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)

Secondary Outcome Measures

Name	Time	Method
Operative Parameters	During initial surgery and within the first 72 hours.	Requirement for transfusion, measured in units of blood.
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)	M.D. Anderson Dysphagia Inventory for assessment of dysphagia
Dumping Symptoms	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
Time to progression	Patients will be monitored for 5 years post-operatively	time from the date of the surgery until local, regional, or metastatic disease is detected
Requirement for feeding tube at 1 year after surgery.	Documented at 1 year follow up visit.	Whether patients are still feeding tube dependent for nutrition at 1 year follow up.
Surgical Time	Initial Surgery	Time from first incision to the end of surgical closure as documented on the nursing record.
Operative blood loss	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)
Margin status of the resected specimen as reported by pathology	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.
Disease Free Survival	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
Progression-free survival	Patients will be monitored for 5 years post-operatively	Time from the date of the surgery until a patient shows sign of disease progression
Voice Function	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
Flap Donor Site Morbidity (RFFF) )	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)
Flap Donor Site Morbidity (ALT)	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)
Time to return to swallowing	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.
Time to return of FULL oral diet	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.
Quality of Life	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

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada