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

Head and Neck Neoplasms Clinical Trial

— GPU vs ALT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03171558
• Other study ID #: H14-00004
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2017
• Last updated: May 30, 2017
• Start date: March 16, 2017
• Est. completion date: March 2023

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: Prisman Eitan, MD, FRCSC
• Phone: 604-875-4126
• Email: eitan.prisman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2023
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Pharyngectomy
• Reconstructive Surgical Procedures

Intervention

Procedure:
• Gastric Pull Up
Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.
• 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.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical Time	Time from first incision to the end of surgical closure as documented on the nursing record.	Initial Surgery
Secondary	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
Secondary	Operative Parameters	Requirement for transfusion, measured in units of blood.	During initial surgery and within the first 72 hours.
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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