Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT03925766
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2019-04-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopy-Assisted Transgastric ERCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D042882', 'term': 'Gallstones'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2019-04-22', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proof the efficacy of laparoscopic assisted transgastric endoscopic retrograde cholangiopancreatography', 'timeFrame': 'April 2019', 'description': 'This technique is a feasible and achievable procedure with low rate of complications for treating patients with altered RYGB anatomy that present biliary tract disorders, allowing an endoscopic treatment and cholecystectomy to be performed in a single setting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biliary disease', 'gallstones', 'obesity'], 'conditions': ['Biliary Obstruction']}, 'descriptionModule': {'briefSummary': 'We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed. The presentation of the case is presented as well a review of the literature.', 'detailedDescription': 'The exclusion of the stomach after Roux-en-Y-Gastric bypass (RYGB) makes access to the biliary tree very challenging for the surgeon or the endoscopist. There are different techniques described to overcome this downside, being laparoscopic assisted trans-gastric endoscopic retrograde cholangiopancreatography (ERCP) approach an outstanding method to access the remnant stomach for reaching the duodenal papilla, with a high rate of success reported. We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed, introducing the duodenoscope through a gastrostomy without the need of an intra-gastric trocar. The patient evolved favorably and was discharged on his second postoperative day without complications.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with altered Roux en Y Gastric Bypass anatomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with altered Roux en Y Gastric Bypass anatomy\n\nExclusion Criteria:\n\n* Patients without Roux en Y Gastric Bypass anatomy'}, 'identificationModule': {'nctId': 'NCT03925766', 'briefTitle': 'Laparoscopy-Assisted Transgastric ERCP', 'organization': {'class': 'OTHER', 'fullName': 'Tecnologico de Monterrey'}, 'officialTitle': 'Laparoscopy-Assisted Transgastric Endoscopic Retrograde Cholangiopancreatography for Choledocholithiasis After Roux-en-Y Gastric Bypass', 'orgStudyIdInfo': {'id': 'LAERCP002'}}, 'contactsLocationsModule': {'locations': [{'zip': '76140', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Escuela Nacional de Medicina, Tecnologico de Monterrey', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tecnologico de Monterrey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}