Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT05342805
Status:
UNKNOWN
Last Update Posted:
2022-04-28
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early complications (30-day complications): rate of anastomotic leakage', 'timeFrame': '30 days after surgery', 'description': 'Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.'}, {'measure': 'Early complications (30-day complications): rate of anastomotic stricture', 'timeFrame': '30 days after surgery', 'description': 'Comparison of the rate of anastomotic stricture. All complications will be classified according to the Clavien-Dindo classification.'}, {'measure': 'Early complications (30-day complications): rate of bleeding', 'timeFrame': '30 days after surgery', 'description': 'Comparison of the rate of bleeding. All complications will be classified according to the Clavien-Dindo classification.'}, {'measure': 'Early complications (30-day complications): rate of pneumonia', 'timeFrame': '30 days after surgery', 'description': 'Comparison of the rate of pneumonia. All complications will be classified according to the Clavien-Dindo classification.'}, {'measure': 'Early complications (30-day complications): rate of mortality.', 'timeFrame': '30 days after surgery', 'description': 'Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.'}, {'measure': 'Early complications (30-day complications): rate of reoperation.', 'timeFrame': '30 days after surgery', 'description': 'Comparison of the rate of reoperation. All complications will be classified according to the Clavien-Dindo classification.'}, {'measure': 'Early outcomes (30-day post operative): length of hospital stay.', 'timeFrame': '30 days after surgery', 'description': 'Comparison of the length of hospital stay.'}, {'measure': 'Early outcomes (30-day post operative): day of oral intake.', 'timeFrame': '30 days after surgery', 'description': 'Comparison of the day of oral intake.'}], 'secondaryOutcomes': [{'measure': 'Postoperative nutritional status: body weight', 'timeFrame': '6, 12 months and 1 year after surgery', 'description': 'Comparison of body weight at 6, 12 months and every year after surgery'}, {'measure': 'Postoperative nutritional status: serum total protein', 'timeFrame': '6, 12 months and 1 year after surgery', 'description': 'Comparison of serum total protein at 6, 12 months and every year after surgery'}, {'measure': 'Postoperative nutritional status: albumin level', 'timeFrame': '6, 12 months and 1 year after surgery', 'description': 'Comparison of albumin level at 6, 12 months and every year after surgery'}, {'measure': 'Postoperative nutritional status: hemoglobin', 'timeFrame': '6, 12 months and 1 year after surgery', 'description': 'Comparison of hemoglobin at 6, 12 months and every year after surgery'}, {'measure': 'Reflux esophagitis', 'timeFrame': '6, 12 months and 1 year after surgery', 'description': 'Reflux esophagitis will be evaluated using the Los Angeles classification at 6, 12 months and every year after surgery'}, {'measure': 'Residue Gastritis Bile', 'timeFrame': '6, 12 months and 1 year after', 'description': 'RGB (Residue Gastritis Bile) classification will be used to evaluate status of remnant stomach 6 to 12 months after surgery'}, {'measure': "Patients' health-related quality of life", 'timeFrame': '6, 12 months and 1 year after', 'description': "Patients' health-related quality of life will be evaluated using GSRS (Gastrointestinal Symptom Rating Scale) score at 6, 12 months and every year after surgery"}, {'measure': 'Late complications: anastomotic stricture', 'timeFrame': '6, 12 months and 1 year after', 'description': 'Comparison of the rate anastomotic stricture complications during the follow-up period'}, {'measure': 'Late complications: anastomotic ulcer', 'timeFrame': '6, 12 months and 1 year after', 'description': 'Comparison of anastomotic ulcer during the follow-up period'}, {'measure': 'Others late complications', 'timeFrame': '6, 12 months and 1 year after', 'description': 'Comparison of other late complications during the follow-up period'}, {'measure': 'Oncological outcomes: overall survival rate', 'timeFrame': '6, 12 months and 1 year after', 'description': 'Comparison of overall survival rate during the follow-up period'}, {'measure': 'Oncological outcomes: rate of death due to the cancer', 'timeFrame': '6, 12 months and 1 year after', 'description': 'Comparison of rate of death due to the cancer, and death from all causes during the follow-up period'}, {'measure': 'Oncological outcomes: recurrence, metastasis', 'timeFrame': '6, 12 months and 1 year after', 'description': 'Comparison of recurrence, metastasis during the follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subtotal stomach', 'narrow gastric tube', 'anastomosis'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Currently, both the subtotal stomach and narrow gastric tube approaches are widely used for esophagogastric anastomosis after esophagectomy. Some stud- ies have concluded that the subtotal gastric conduit is superior to the wide gastric-tube approach, as it provides better protection of the submucosal vessels and can slightly increase gastric capacity.\n\nFurthermore, blood perfusion significantly decreases after tubular gastric surgery.', 'detailedDescription': 'Stomach is the most common esophageal subtitute after a esophagectomy procedure, because it has a abundant blood supply and the need for only one anastomosis. However, cervical esophago-gastro anastomosis still has a high risk of complications, especially anastomosis leakage (11.9 - 25 % ).\n\nThere are three types of gastric subtitute: whole stomach, subtotal stomach and narrow gastric tube. While whole stomach and subtotal stomach has an advantage in the submucosal vascular network, a narrow tube is excellent elasticity and the ease with which it can be pulled up into the neck without tension, that could affect leakage rate.\n\nOn the other hand, after esophagectomy, nutrition status and quality of life (QoL) had decreased due to effect of adjuvant therapy, lower quantity of food intake, gastro-esophageal reflux and other postoperative syndromes. Several studies had shown the affect of the width of gastric tube to the postoperative nutrition and QoL, however, the results were not homogenous. This study aims to compared two types of gastric subtitute after esophagectomy: subtotal stomach and narrow gastric tube'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologic finding by esophageal endoscopy: confirmed esophageal cancer.\n* Indication for esophagectomy\n* Age: 18 - 80 year old\n* Tumor located at the middle or lower third of the esophagus\n* ASA score: ≤ 3\n* Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)\n\nExclusion Criteria:\n\n* Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed esophageal cancer\n* Pregnant patient\n* Using colon or intesinal conduit'}, 'identificationModule': {'nctId': 'NCT05342805', 'briefTitle': 'Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Ho Chi Minh City (UMC)'}, 'officialTitle': 'Comparison of Subtotal Stomach and Narrow Gastric Tube for Reconstruction After Esophagectomy for Gastric Cancer: a Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': '16/GCN-HDDD 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subtotal stomach', 'description': 'The vessels at the anastomosis of right and left gastric arteries were separated, then the proximal haft of lesser curvature and cardia was resected using linear staplers.', 'interventionNames': ['Procedure: Narrow gastric tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Narrow gastric tube', 'description': 'At the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler.', 'interventionNames': ['Procedure: Narrow gastric tube']}], 'interventions': [{'name': 'Narrow gastric tube', 'type': 'PROCEDURE', 'description': 'At the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler', 'armGroupLabels': ['Narrow gastric tube', 'Subtotal stomach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University Medical Center Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'centralContacts': [{'name': 'Long D Vo, MD, PhD', 'role': 'CONTACT', 'email': 'long.vd@umc.edu.vn', 'phone': '+84. 918 133 915'}], 'overallOfficials': [{'name': 'Long D Vo, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Center, HCMC, VN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Ho Chi Minh City (UMC)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}