Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-17 @ 5:07 AM
Study NCT ID:
NCT01980420
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with postoperative GIQLI score greater than preoperative score', 'timeFrame': '50% excess weight loss (about 6 months post surgery)', 'description': 'Patients with postoperative GIQLI (Gastro-Intestinal Quality of Life Index) score greater than preoperative score'}], 'secondaryOutcomes': [{'measure': 'Quality of life (GIQLI)', 'timeFrame': '50% of excess weight loss (about 6 months post surgery)', 'description': 'Quality of life (Gastro-Intestinal Quality of Life Index)'}, {'measure': 'GERD and dysphagia symptoms (GSAS questionnaire)', 'timeFrame': '50% of excess weight loss (about 6 months post surgery)', 'description': 'GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale'}, {'measure': 'Functional examinations', 'timeFrame': '50% of excess weight loss (about 6 months post surgery)', 'description': 'Include:\n\n* Dynamic MRI\n* High resolution manometry\n* pH impedance\n* upper gastro-intestinal study (UGI)'}, {'measure': 'EndoFLIP® measures', 'timeFrame': 'Intra-operatively', 'description': 'Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure'}, {'measure': 'Surgical video analysis', 'timeFrame': 'within 6 months post surgery', 'description': 'Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome'}, {'measure': 'Per and post-operative complications', 'timeFrame': 'within 6 months post surgery', 'description': 'Complications occuring during surgery and within 6 months of surgery (reach of 50% of excess weight loss)'}, {'measure': 'Cost of exploratory exams', 'timeFrame': '50% excess weight loss (about 6 months post surgery)'}, {'measure': 'Cost of exploratory exams', 'timeFrame': 'Within 2 months prior to surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleeve gastrectomy', 'Oesogastric junction - GEJ', 'Dynamic MRI Imaging'], 'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '32207049', 'type': 'DERIVED', 'citation': 'Quero G, Fiorillo C, Dallemagne B, Mascagni P, Curcic J, Fox M, Perretta S. The Causes of Gastroesophageal Reflux after Laparoscopic Sleeve Gastrectomy: Quantitative Assessment of the Structure and Function of the Esophagogastric Junction by Magnetic Resonance Imaging and High-Resolution Manometry. Obes Surg. 2020 Jun;30(6):2108-2117. doi: 10.1007/s11695-020-04438-y.'}]}, 'descriptionModule': {'briefSummary': 'Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.', 'detailedDescription': 'Effectiveness of sleeve gastrectomy is between gastric banding and gastric bypass. However, a proportion of patients that undergo surgery, report troublesome and persistent dysphagia, pain, new onset or worsening of gastro-esophageal reflux (GER) requiring treatment. Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome. Current investigations based on traditional intra-luminal imaging (endoscopy) and radiology (UGI series) may not provide adequate preoperative assessment of esophago-gastric dynamics. Current practice in the creation of a sleeve gastrectomy involves the use of a bougie or endoscope around which the sleeve is stapled. There is no consensus on the diameter of this bougie and this intraoperative calibration may alter the gastro-esophageal junction (GEJ) anatomy, does not provide real time physiology feedback, and allows only for a rough approximation of the size of the sleeve providing no information about the distensibility and pressure gradient of the newly created gastric tube as it is filled. A more distensible sleeve will have lower intra-gastric pressure, and thus will theoretically be expected to reduce the incidence of side effects. As laparoscopic sleeve gastrectomy is performed with increasing frequency, there is a need for development of tools to assist the surgeon in modeling properly and standardize the gastroplasty. This study will be based on a strict assessment of the anatomical and functional characteristics of the "ideal "gastric sleeve, using existing imaging modalities (endoscopy - CT scan- MRI - HRM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient, male or female over 18 years old\n* Patient scheduled to undergo a sleeve gastrectomy for obesity\n* Patient with surgical indication validated by the obesity multidisciplinary meeting (RCP)\n* Patient able to understand the study and to provide written informed consent\n* Patient registered with the French social security regime\n\nNon-inclusion criteria:\n\n* Patient unable to give written informed consent\n* Patient presenting contra-indication to the conduct of an MRI (claustrophobia, implantable medical devices)\n* Patient presenting risks of allergic reaction to MRI contrast agents (gadolinium)\n* Patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures\n* Patient pregnant or breast-feeding\n* Patient within exclusion period from other clinical trial\n* Patient having forfeited their freedom of an administrative or legal obligation\n* Patient being under guardianship"}, 'identificationModule': {'nctId': 'NCT01980420', 'acronym': 'FFSI', 'briefTitle': 'Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function', 'organization': {'class': 'OTHER', 'fullName': 'IHU Strasbourg'}, 'officialTitle': 'Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function', 'orgStudyIdInfo': {'id': '13-001'}, 'secondaryIdInfos': [{'id': '2013-A00723-42', 'type': 'OTHER', 'domain': 'ANSM France'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sleeve gastrectomy', 'description': 'All patients will undergo sleeve gastrectomy', 'interventionNames': ['Procedure: Laparoscopic sleeve gastrectomy']}], 'interventions': [{'name': 'Laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.', 'armGroupLabels': ['Sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Silvana Perretta, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IHU Strasbourg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}