NCT03171558UnknownNot Applicable
Gastric Pull up Versus Free Flaps Reconstruction (Anterolateral Thigh and Radial Forearm Free Flap) for Laryngo-pharyngeal Defects: A Prospective Randomized Trial
University of British Columbia2 sites in 1 country20 target enrollmentStarted: March 16, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Type and number of postoperative complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Type and number of postoperative complications
Time Frame: 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 Outcomes
- Operative Parameters(During initial surgery and within the first 72 hours.)
- 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(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))
- Time to progression(Patients will be monitored for 5 years post-operatively)
- Requirement for feeding tube at 1 year after surgery.(Documented at 1 year follow up visit.)
- Surgical Time(Initial Surgery)
- Operative blood loss(Initial surgery)
- Margin status of the resected specimen as reported by pathology(At the time of surgery)
- Disease Free Survival(Patients will be monitored for 5 years post-operatively)
- Progression-free survival(Patients will be monitored for 5 years post-operatively)
- 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))
- Flap Donor Site Morbidity (RFFF) )(Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total))
- Flap Donor Site Morbidity (ALT)(Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total))
- 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 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))
- Quality of Life(Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total))
Investigators
Eitan Prisman
Principal Investigator
University of British Columbia
Study Sites (2)
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