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Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects (GPU vs ALT)

Primary Purpose

Head and Neck Neoplasms, Pharyngectomy, Reconstructive Surgical Procedures

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gastric Pull Up
Free Flap Surgery
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gastric Pull Up

Free Flap

Arm Description

Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect.

Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Surgical Time
Time from first incision to the end of surgical closure as documented on the nursing record.
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)
Operative Parameters
Requirement for transfusion, measured in units of blood.
Flap Donor Site Morbidity (RFFF) )
Donor site associated quality of life (Toronto Extremity Salvage Score - Upper Extremity)
Flap Donor Site Morbidity (ALT)
Donor site associated quality of life (Toronto Extremity Salvage Score - Lower Extremity)
Time to return to swallowing
Time from surgery to swallowing liquids.
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.
Requirement for feeding tube at 1 year after surgery.
Whether patients are still feeding tube dependent for nutrition at 1 year follow up.
Voice Function
Measured by Voice Handicap Index -10
Dysphagia
M.D. Anderson Dysphagia Inventory for assessment of dysphagia
Dumping Symptoms
Assessed with the dumping symptom rating scale
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
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.
Time to progression
time from the date of the surgery until local, regional, or metastatic disease is detected
Disease Free Survival
Time from the date of the surgery until a patient experiences a recurrence, a new primary cancer or death
Progression-free survival
Time from the date of the surgery until a patient shows sign of disease progression

Full Information

First Posted
February 22, 2017
Last Updated
May 30, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03171558
Brief Title
Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Pharyngectomy, Reconstructive Surgical Procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastric Pull Up
Arm Type
Experimental
Arm Description
Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect.
Arm Title
Free Flap
Arm Type
Active Comparator
Arm Description
Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect.
Intervention Type
Procedure
Intervention Name(s)
Gastric Pull Up
Intervention Description
Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.
Intervention Type
Procedure
Intervention Name(s)
Free Flap Surgery
Other Intervention Name(s)
Anterolateral thigh free flap and radial forearm free flap
Intervention Description
Using radial forearm free flap or anterolateral thigh free flap to reconstruct the cervical esophagus and pharynx after pharyngectomy and cervical esophagectomy.
Primary Outcome Measure Information:
Title
Type and number of postoperative complications
Description
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)
Time Frame
Within 90 days of surgery occurring on the same or separate admission.
Secondary Outcome Measure Information:
Title
Surgical Time
Description
Time from first incision to the end of surgical closure as documented on the nursing record.
Time Frame
Initial Surgery
Title
Operative blood loss
Description
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)
Time Frame
Initial surgery
Title
Operative Parameters
Description
Requirement for transfusion, measured in units of blood.
Time Frame
During initial surgery and within the first 72 hours.
Title
Flap Donor Site Morbidity (RFFF) )
Description
Donor site associated quality of life (Toronto Extremity Salvage Score - Upper Extremity)
Time Frame
Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Title
Flap Donor Site Morbidity (ALT)
Description
Donor site associated quality of life (Toronto Extremity Salvage Score - Lower Extremity)
Time Frame
Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Title
Time to return to swallowing
Description
Time from surgery to swallowing liquids.
Time Frame
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)
Title
Time to return of FULL oral diet
Description
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.
Time Frame
Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Title
Requirement for feeding tube at 1 year after surgery.
Description
Whether patients are still feeding tube dependent for nutrition at 1 year follow up.
Time Frame
Documented at 1 year follow up visit.
Title
Voice Function
Description
Measured by Voice Handicap Index -10
Time Frame
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)
Title
Dysphagia
Description
M.D. Anderson Dysphagia Inventory for assessment of dysphagia
Time Frame
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)
Title
Dumping Symptoms
Description
Assessed with the dumping symptom rating scale
Time Frame
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)
Title
Quality of Life
Description
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
Time Frame
Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Title
Margin status of the resected specimen as reported by pathology
Description
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.
Time Frame
At the time of surgery
Title
Time to progression
Description
time from the date of the surgery until local, regional, or metastatic disease is detected
Time Frame
Patients will be monitored for 5 years post-operatively
Title
Disease Free Survival
Description
Time from the date of the surgery until a patient experiences a recurrence, a new primary cancer or death
Time Frame
Patients will be monitored for 5 years post-operatively
Title
Progression-free survival
Description
Time from the date of the surgery until a patient shows sign of disease progression
Time Frame
Patients will be monitored for 5 years post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prisman Eitan, MD, FRCSC
Phone
604-875-4126
Email
eitan.prisman@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Oleksandr Butskiy, MD
Phone
604-375-7529
Email
butskiy.alex@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prisman Eitan, MD, FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eitan Prisman, MD
Phone
604.875.4126
Email
eitan.prisman@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers.

Learn more about this trial

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

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