Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-29 @ 2:08 AM
Study NCT ID:
NCT02767505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2015-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bypass Equipoise Sleeve Trial (BEST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1752}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '5 years', 'description': 'Non-inferiority for SG is defined as \\< 5% weight difference'}, {'measure': 'Serious adverse events', 'timeFrame': '5 years', 'description': 'Superiority for SG is having 35% less serious (substantial) adverse events compared to RYGB'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'General description of patterns of all adverse events'}, {'measure': 'Weight loss', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Between baseline and 1 and 2 years'}, {'measure': 'Number of patients with arterial cardiovascular events', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Composite of myocardial infarction+ stroke+ other occlusive arterial condition'}, {'measure': 'Number of patients with venous event', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Composite of Deep vein thrombosis+ Pulmonary emboli+ other venous event'}, {'measure': 'Number of patients with diabetes requiring drug treatment', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Development of diabetes measured as numbers of patients having a diabetes diagnosis and oral medication and injection therapy'}, {'measure': 'Number of patients with a psychiatric morbidity', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Number of patients with a psychiatric morbidity'}, {'measure': 'Number of patients with hypertension treatment', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Number of patients with hypertension treatment (any type of Medical treatment)'}, {'measure': 'Number of patients diagnosed with a malignancy', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Number of patients diagnosed with a malignancy'}, {'measure': 'Number of patients with dyslipidemia treatment', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Number of patients with diagnosis of dyslipidemia and on oral lipid lowering treatment'}, {'measure': 'Weight in men and women', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Analyses of the primary outcome weight in men and women'}, {'measure': 'serious adverse events in men and women', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Analyses of the primary outcome serious adverse events in men and women'}, {'measure': 'Weight in patients with BMI >43 vs <43 kg/m2.', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Analyses of the primary outcome weight in patients with BMI \\>43 vs \\<43 kg/m2.'}, {'measure': 'Serious adverse events in patients with BMI >43 vs <43 kg/m2', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Analyses of the primary outcome serious adverse events in patients with BMI \\>43 vs \\<43 kg/m2.'}, {'measure': 'Weight in patients aged 18-25 y, 25-50 y, or >50 y', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Analyses of the primary outcome weight in patients aged 18-25 y, 25-50 y, or \\>50 y'}, {'measure': 'Serious adverse events in patients aged 18-25 y, 25-50 y, or >50 y', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Analyses of the primary outcome serious adverse events in patients aged 18-25 y, 25-50 y, or \\>50 y'}, {'measure': 'Mineral nutritional status', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Serum concentrations of iron depots, zinc, magnesium, selenium and copper'}, {'measure': 'Vitamin nutritional status', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Serum concentrations of vitamins (Vitamin B12, Vitamin D, Vitamin A, thiamin)'}, {'measure': 'Serum concentrations of albumin', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Serum concentrations of Albumin'}, {'measure': 'Changes in quality of Life assessed with EQ-5D', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Assessed with EQ-5D'}, {'measure': 'Changes in quality of Life assessed with Obesity Problems (OP)', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Assessed with Obesity Problems (OP)'}, {'measure': 'Changes in quality of Life assessed with Short Form-36', 'timeFrame': 'Baseline, 1, 2, 5 and 10 years', 'description': 'Assessed with SF-36'}, {'measure': 'Alcohol consumption', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'Assessed by AUDIT'}, {'measure': 'Gastro-esophageal reflux disease', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'Gastro-esophageal reflux disease is defined as present/ not present in at least one of following modalities: Questionnaire DeMeester score, 24h pH manometry and/or gastroscopy'}, {'measure': 'Fracture incidence', 'timeFrame': '2, 5 and 10 years', 'description': 'From clinical data and national registry'}, {'measure': 'Bone density and body composition', 'timeFrame': '10 years', 'description': 'Dual energy X-ray Absorptiometry (DEXA) in at least a subgroup of 500+500'}, {'measure': 'Mortality and cause of death', 'timeFrame': '5, 10, 20 and 30 years', 'description': 'National Cause of Death registry'}, {'measure': 'Health care consumption, In hospital registry', 'timeFrame': '5, 10, 20 and 30 years', 'description': 'Data from In hospital registry (Days in hospital)'}, {'measure': 'Health care consumption,', 'timeFrame': '5, 10, 20 and 30 years', 'description': 'Data from Outpatient registry ( number of visits)'}, {'measure': 'Health care consumption', 'timeFrame': '5, 10, 20 and 30 years', 'description': 'National drug registry (type of drug)'}, {'measure': 'Development of co-morbidities from national registry data', 'timeFrame': '5, 10, 20, 30 years', 'description': 'National stroke registry, National Cardiac registry, National Diabetes Registry, Cancer registry'}, {'measure': 'Formal cost effective analysis', 'timeFrame': '5, 10 and 20 years', 'description': 'Cost per quality-adjusted life-year and life-year)'}, {'measure': 'Dietary intake', 'timeFrame': '1 and 10 years', 'description': 'Questionnaire regarding food intake (E14x)'}, {'measure': 'Eating patterns', 'timeFrame': '1 and 10 years', 'description': 'Three Factor Eating Questionnaire (TFEQ)'}, {'measure': 'Gastro-intestinal side effects', 'timeFrame': '1 and 10 years', 'description': 'Questionnaire: Gastro-intestinal Symptom Rating Score (GSRS)'}, {'measure': 'Dumping symptoms', 'timeFrame': '1 and 10 years', 'description': 'Questionnaire: Dumping Symptom Rating Score (DSRS)'}, {'measure': 'Adverse events', 'timeFrame': '30 days postop, 1, 2, 5 and 10 years', 'description': 'Clinical data combined with national registry data'}, {'measure': 'Peri-operative outcome, Complications', 'timeFrame': 'Up to 30 days postop', 'description': 'Complications; Surgical (minor/major) and medical'}, {'measure': 'Peri-operative outcome, surgical time', 'timeFrame': 'Up to 30 days postop', 'description': 'surgical time (min)'}, {'measure': 'Peri-operative outcome, sick leave', 'timeFrame': 'Up to 30 days postop', 'description': 'sick leave (days)'}, {'measure': 'Peri-operative outcome, length of stay', 'timeFrame': 'Up to 30 days postop', 'description': 'length of stay (days)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Severe Obesity']}, 'referencesModule': {'references': [{'pmid': '38289603', 'type': 'DERIVED', 'citation': 'Hedberg S, Thorell A, Osterberg J, Peltonen M, Andersson E, Naslund E, Hertel JK, Svanevik M, Stenberg E, Neovius M, Naslund I, Wiren M, Ottosson J, Olbers T; BEST Study Group. Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353141. doi: 10.1001/jamanetworkopen.2023.53141.'}, {'pmid': '31279778', 'type': 'DERIVED', 'citation': 'Hedberg S, Olbers T, Peltonen M, Osterberg J, Wiren M, Ottosson J, Thorell A; BEST study group. BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy. Contemp Clin Trials. 2019 Sep;84:105809. doi: 10.1016/j.cct.2019.07.001. Epub 2019 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'This is nationwide registry-based randomised clinical multicenter trial in which patients will be randomised to gastric bypass (RYGB) or sleeve gastrectomy (SG). The co-primary endpoint are weight control over 5 years and the amount of severe adverse events. Additionally the investigators have predefined a number of secondary endpoints, and the trial has a sufficient number of patients to allow comparisons across subgroups.', 'detailedDescription': 'Follow-up of the patients will use the routines respectively for regular follow-up on the Scandinavian Obesity Surgery Registry (SOReg) after 6v, 1 year, 2 years, and after 5 years.\n\nIn order to evaluate if SG has advantages compared to the previous standard, the investigators want to examine whether SG operations are equivalent (non-inferiority) for weight loss and weight stability five years after surgery in comparison to RYGB, and if SG is associated with fewer long-term complications (superiority). The primary outcome measure emanates from assessment of long term weight management and the frequency of serious complications.\n\nThe unforeseen global Covid-19 pandemic resulted in that almost all elective benign surgery in Scandinavia was cancelled from March 2020. Thus, the pandemic had severe consequences on the recruitment to the BEST trial during 2020-2021.\n\nDuring autumn of 2021 the BEST steering committee decided to perform an additional analysis of the power for primary endpoints.\n\nAdditional information (Courcoulas et al, JAMA Surg 2020 March; Howard et al, JAMA Surg 2021 Dec) revealed that the risk of any of the predefined substantial adverse events after bariatric surgery is higher than previously anticipated in the revised power calculation, i.e. \\>25% instead of 13%. These figures were confirmed in an analysis of real-world data from the bariatric national quality register SOReg in Sweden which registered all patients undergoing sleeve or bypass in Sweden since 2007.\n\nAn independent statistician performed the analysis based on information above, but also on 2-year data in BEST. In conclusion, it was stated:\n\nTwo post hoc power analyses were conducted based on the data from February 2022:\n\n1. Weight reduction. In the protocol the following is stated "This sample size will also have \\>95% power to evaluate non-inferiority of 5% weight loss difference over 5 years between the two groups, assuming 15 kg standard deviation in weight loss over follow-up with two-sided 2.5% significance level.". The post hoc power calculation is based on the two-year follow up data where an average weight loss for all patients (both groups, N=1031) of 29.3 kg was attained with a Sd=21.6. Given a loss to follow up of 20% from 2 year follow up to the 5-year follow up the sample size is assumed to be (1031\\*0.80)/2=413 patients per group. With a non-inferiority level of 5 kg weight loss the power is found to be 90% if n=393 per group, and 95% if n=486 per group (https://www.sealedenvelope.com/power/continuous-noninferior/).\n2. Substantial adverse events. This post hoc power calculation is for a superiority test where the rate is assumed to be 25% for the gastric bypass at 5 years and sleeve would have a 35% lower level, i e 25%\\*0.65=16.25%. Given a sample of n=413 per group the post hoc power will then be 87.5%.\n\nTaking information above into account and in the interest of not prolonging inclusion period unnecessarily the trial steering committee took a decision to stop inclusion in BEST during spring 2022 (final date 31st of March). At termination of inclusion the number of participants that had been included and operated in BEST were 1752. The trial Data Safety and Monitoring Committee reviewed and supported the decision before termination of recruitment to the BEST trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 35-50 kg/m2\n* Ability to understand and decide on the merits of the study participation\n* Accepted for bariatric surgery\n* Must understand the information, and be able to make a decisions about participation in the study\n\nExclusion Criteria:\n\n* Previous bariatric surgery, anti reflux surgery or other gastric surgery\n* Moderate to severe reflux disease, Barretts oesophagus or known hiatus hernia \\>4 cm\n* Unstable mental illness or other known contraindication to bariatric surgery.\n* Planned significant surgery at the same time\n* Inflammatory bowel disease\n* ongoing drug or substance abuse\n* not appropriate to randomise the patient, according to surgeon'}, 'identificationModule': {'nctId': 'NCT02767505', 'acronym': 'BEST', 'briefTitle': 'Bypass Equipoise Sleeve Trial (BEST)', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Bypass Equipoise Sleeve Trial (BEST); A Randomised Controlled Multicenter Trial Comparing Gastric Bypass and Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': '478-15, version 5 2020-03-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleeve gastrectomy', 'description': 'Laparoscopic sleeve gastrectomy', 'interventionNames': ['Other: Sleeve gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gastric bypass', 'description': 'Laparoscopic Roux-en-Y gastric bypass', 'interventionNames': ['Other: gastric bypass']}], 'interventions': [{'name': 'gastric bypass', 'type': 'OTHER', 'description': 'Type of surgery: gastric bypass', 'armGroupLabels': ['Gastric bypass']}, {'name': 'Sleeve gastrectomy', 'type': 'OTHER', 'description': 'Typ of surgery: sleeve gastrectomy', 'armGroupLabels': ['Sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tønsberg', 'country': 'Norway', 'facility': 'Sentralsykehuset Vestfold', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}, {'city': 'Falun', 'country': 'Sweden', 'facility': 'Falu Hospital', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'city': 'Gävle', 'country': 'Sweden', 'facility': 'Gävle Hospital', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'zip': '416 50', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Östra Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '392 85', 'city': 'Kalmar', 'country': 'Sweden', 'facility': 'Kalmar County Hospital', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}, {'zip': '701 85', 'city': 'Lindesberg', 'country': 'Sweden', 'facility': 'Lindesbergs Hospital', 'geoPoint': {'lat': 59.59202, 'lon': 15.2304}}, {'zip': 'S-58183', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Ljungby', 'country': 'Sweden', 'facility': 'Ljungby Hospital', 'geoPoint': {'lat': 56.83324, 'lon': 13.94082}}, {'city': 'Lycksele', 'country': 'Sweden', 'facility': 'Lycksele Hospital', 'geoPoint': {'lat': 64.59537, 'lon': 18.67351}}, {'city': 'Mora', 'country': 'Sweden', 'facility': 'Mora Hospital', 'geoPoint': {'lat': 61.00704, 'lon': 14.54316}}, {'city': 'Norrköping', 'country': 'Sweden', 'facility': 'Vrinnevi Hospital, Norrköping', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}, {'zip': '701 85', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Skåne', 'country': 'Sweden', 'facility': 'GB Obesitas', 'geoPoint': {'lat': 59.48333, 'lon': 13.33333}}, {'zip': '541 85', 'city': 'Skövde', 'country': 'Sweden', 'facility': 'Skaraborgs Hospital', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': '152 86', 'city': 'Södertälje', 'country': 'Sweden', 'facility': 'Södertälje Hospital', 'geoPoint': {'lat': 59.19554, 'lon': 17.62525}}, {'zip': '116 91', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Ersta Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '182 88', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Capio S:t Görans Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Stockholm South General Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Torsby', 'country': 'Sweden', 'facility': 'Torsby Hospital', 'geoPoint': {'lat': 60.13527, 'lon': 13.0082}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Torsten Olbers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linköping University, Dept of BKV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ersta Hospital, Sweden', 'class': 'OTHER'}, {'name': 'Region Örebro County', 'class': 'OTHER'}, {'name': 'Kalmar County Hospital', 'class': 'OTHER'}, {'name': 'Lindesbergs Hospital', 'class': 'UNKNOWN'}, {'name': 'Danderyd Hospital', 'class': 'OTHER'}, {'name': 'Skaraborg Hospital', 'class': 'OTHER_GOV'}, {'name': 'Sodertalje Hospital', 'class': 'OTHER'}, {'name': 'Östra Hospital', 'class': 'OTHER'}, {'name': 'Mora Hospital', 'class': 'UNKNOWN'}, {'name': 'Torsby Hospital', 'class': 'UNKNOWN'}, {'name': 'Stockholm South General Hospital', 'class': 'OTHER'}, {'name': 'Gävle Hospital', 'class': 'OTHER'}, {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, {'name': 'Lycksele Hospital', 'class': 'UNKNOWN'}, {'name': 'Falu Hospital', 'class': 'OTHER'}, {'name': 'Vrinnevi Hospital, Norrköping', 'class': 'UNKNOWN'}, {'name': 'Capio S:t Görans Hospital', 'class': 'UNKNOWN'}, {'name': 'Ljungby Hospital', 'class': 'UNKNOWN'}, {'name': 'Sykehuset i Vestfold HF', 'class': 'OTHER'}, {'name': 'Gjövik Hospital, Norway', 'class': 'UNKNOWN'}, {'name': 'GB Obesitas Skane', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}