Head and Neck NeoplasmsGPU vs ALTNCT03171558
Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects
A study testing Gastric Pull Up and Free Flap Surgery in people with Head and Neck Neoplasms and Pharyngectomy, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Pharyngectomy, Reconstructive Surgical Procedures
- What is being tested?
- Gastric Pull Up and Free Flap Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2017to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Eitan Prisman, MD, 604.875.4126, eitan.prisman@gmail.com
About this study
Official title: Gastric Pull up Versus Free Flaps Reconstruction (Anterolateral Thigh and Radial Forearm Free Flap) for Laryngo-pharyngeal Defects: A Prospective Randomized Trial
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.
- Being tested
- Gastric Pull Up, Free Flap Surgery
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Pull UpProcedure or surgery
Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.
Free Flap SurgeryProcedure or surgery
Also called Anterolateral thigh free flap and radial forearm free flap
Using radial forearm free flap or anterolateral thigh free flap to reconstruct the cervical esophagus and pharynx after pharyngectomy and cervical esophagectomy.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Pull Up | Experimental | Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect. Receives: Procedure: Gastric Pull Up |
| Free Flap | Active comparator | Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect. Receives: Procedure: Free Flap Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 90 days of surgery occurring on the same or separate admission.
Secondary outcomes (16)
Surgical Time
Time from first incision to the end of surgical closure as documented on the nursing record.
Measured: 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)
Measured: Initial surgery
Operative Parameters
Requirement for transfusion, measured in units of blood.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Documented at 1 year follow up visit.
Voice Function
Measured by Voice Handicap Index -10
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: At the time of surgery
Time to progression
time from the date of the surgery until local, regional, or metastatic disease is detected
Measured: 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
Measured: 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
Measured: Patients will be monitored for 5 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start16 Mar 2017
- Primary completionMar 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eitan Prisman, University of British Columbia
- Investigators
- Prisman Eitan, MD, FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171558
- Sponsor's protocol ID
- H14-00004
- Acronym
- GPU vs ALT
- Status last verified
- May 2017
- First submitted
- 22 Feb 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Pull up Versus Free Flaps Reconstruction (Anterolateral Thigh and Radial Forearm Free Flap) for Laryngo-pharyngeal Defects: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03171558
- Acronym / sponsor ID
- GPU vs ALT / H14-00004
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Pull Up | Experimental | Procedure: Gastric Pull UpPatients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect. |
| Free Flap | Active comparator | Procedure: Free Flap SurgeryPatients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric Pull UpUsing gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy. | Procedure or surgery | Gastric Pull Up |
| Free Flap SurgeryAlso: Anterolateral thigh free flap and radial forearm free flapUsing radial forearm free flap or anterolateral thigh free flap to reconstruct the cervical esophagus and pharynx after pharyngectomy and cervical esophagectomy. | Procedure or surgery | Free Flap |
Primary outcome
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)
16 secondary outcomes
Surgical Time
Time frame: Initial Surgery
Operative blood loss
Time frame: Initial surgery
Operative Parameters
Time frame: During initial surgery and within the first 72 hours.
Flap Donor Site Morbidity (RFFF) )
Time frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Flap Donor Site Morbidity (ALT)
Time frame: 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 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)
Time to return of FULL oral diet
Time frame: 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.
Time frame: Documented at 1 year follow up visit.
Voice Function
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)
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)
Dumping Symptoms
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)
Quality of Life
Time frame: 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
Time frame: At the time of surgery
Time to progression
Time frame: Patients will be monitored for 5 years post-operatively
Disease Free Survival
Time frame: Patients will be monitored for 5 years post-operatively
Progression-free survival
Time frame: Patients will be monitored for 5 years post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prisman Eitan, MD, FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Pull Up and Free Flap Surgery in people with Head and Neck Neoplasms and Pharyngectomy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prisman Eitan, MD, FRCSC (604-875-4126, eitan.prisman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type and number of postoperative complications (time frame: Within 90 days of surgery occurring on the same or separate admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.