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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Pull Up | Experimental | Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect. |
|
| Free Flap | Active Comparator | Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Pull Up | Procedure | Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy. |
|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prisman Eitan, MD, FRCSC | Contact | 604-875-4126 | eitan.prisman@gmail.com | |
| Oleksandr Butskiy, MD | Contact | 604-375-7529 | butskiy.alex@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Prisman Eitan, MD, FRCSC | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
Individual participant data will not be shared with other researchers.
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. |
|
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| 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 |