Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-05 @ 10:10 PM
Study NCT ID:
NCT03171558
Status:
UNKNOWN
Last Update Posted:
2017-05-31
First Post:
2017-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type and number of postoperative complications', 'timeFrame': 'Within 90 days of surgery occurring on the same or separate admission.', '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)'}], 'secondaryOutcomes': [{'measure': 'Surgical Time', 'timeFrame': 'Initial Surgery', 'description': 'Time from first incision to the end of surgical closure as documented on the nursing record.'}, {'measure': 'Operative blood loss', 'timeFrame': 'Initial surgery', '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)'}, {'measure': 'Operative Parameters', 'timeFrame': 'During initial surgery and within the first 72 hours.', 'description': 'Requirement for transfusion, measured in units of blood.'}, {'measure': 'Flap Donor Site Morbidity (RFFF) )', 'timeFrame': 'Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)', 'description': 'Donor site associated quality of life (Toronto Extremity Salvage Score - Upper Extremity)'}, {'measure': 'Flap Donor Site Morbidity (ALT)', 'timeFrame': 'Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)', 'description': 'Donor site associated quality of life (Toronto Extremity Salvage Score - Lower Extremity)'}, {'measure': 'Time to return to swallowing', 'timeFrame': '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)', 'description': 'Time from surgery to swallowing liquids.'}, {'measure': 'Time to return of FULL oral diet', 'timeFrame': 'Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)', '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.'}, {'measure': 'Requirement for feeding tube at 1 year after surgery.', 'timeFrame': 'Documented at 1 year follow up visit.', 'description': 'Whether patients are still feeding tube dependent for nutrition at 1 year follow up.'}, {'measure': 'Voice Function', 'timeFrame': '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)', 'description': 'Measured by Voice Handicap Index -10'}, {'measure': 'Dysphagia', 'timeFrame': '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)', 'description': 'M.D. Anderson Dysphagia Inventory for assessment of dysphagia'}, {'measure': 'Dumping Symptoms', 'timeFrame': '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)', 'description': 'Assessed with the dumping symptom rating scale'}, {'measure': 'Quality of Life', 'timeFrame': 'Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)', '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'}, {'measure': 'Margin status of the resected specimen as reported by pathology', 'timeFrame': 'At the time of surgery', '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.'}, {'measure': 'Time to progression', 'timeFrame': 'Patients will be monitored for 5 years post-operatively', 'description': 'time from the date of the surgery until local, regional, or metastatic disease is detected'}, {'measure': 'Disease Free Survival', 'timeFrame': 'Patients will be monitored for 5 years post-operatively', 'description': 'Time from the date of the surgery until a patient experiences a recurrence, a new primary cancer or death'}, {'measure': 'Progression-free survival', 'timeFrame': 'Patients will be monitored for 5 years post-operatively', 'description': 'Time from the date of the surgery until a patient shows sign of disease progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms', 'Pharyngectomy', 'Reconstructive Surgical Procedures']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to provide informed consent, attend follow-up visits and complete questionnaires\n* Have an Eastern Cooperation Oncology Group (ECOG) performance status of 0-2\n* Patients with carcinoma of thyroid, larynx, hypopharynx, or cervical esophagus requiring surgery as a primary treatment modality or after chemoradiation treatment failure\n* Laryngectomy and circumferential pharyngectomy as recommended by the head and neck tumor board\n\nExclusion Criteria:\n\n* Serious medical co morbidities or other contraindications to surgery\n* Metastatic disease\n* Pregnant or lactating women\n* 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.\n* 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'}, 'identificationModule': {'nctId': 'NCT03171558', 'acronym': 'GPU vs ALT', 'briefTitle': 'Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Gastric Pull up Versus Free Flaps Reconstruction (Anterolateral Thigh and Radial Forearm Free Flap) for Laryngo-pharyngeal Defects: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'H14-00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gastric Pull Up', 'description': 'Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect.', 'interventionNames': ['Procedure: Gastric Pull Up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Free Flap', 'description': 'Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect.', 'interventionNames': ['Procedure: Free Flap Surgery']}], 'interventions': [{'name': 'Gastric Pull Up', 'type': 'PROCEDURE', 'description': 'Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.', 'armGroupLabels': ['Gastric Pull Up']}, {'name': 'Free Flap Surgery', 'type': 'PROCEDURE', 'otherNames': ['Anterolateral thigh free flap and radial forearm free flap'], 'description': 'Using radial forearm free flap or anterolateral thigh free flap to reconstruct the cervical esophagus and pharynx after pharyngectomy and cervical esophagectomy.', 'armGroupLabels': ['Free Flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Eitan Prisman, MD', 'role': 'CONTACT', 'email': 'eitan.prisman@gmail.com', 'phone': '604.875.4126'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Prisman Eitan, MD, FRCSC', 'role': 'CONTACT', 'email': 'eitan.prisman@gmail.com', 'phone': '604-875-4126'}, {'name': 'Oleksandr Butskiy, MD', 'role': 'CONTACT', 'email': 'butskiy.alex@gmail.com', 'phone': '604-375-7529'}], 'overallOfficials': [{'name': 'Prisman Eitan, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eitan Prisman', 'investigatorAffiliation': 'University of British Columbia'}}}}