Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-03-03 @ 12:04 AM
Study NCT ID:
NCT01620632
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}, {'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-05', 'studyFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2012-06-13', 'lastUpdatePostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patients with altered gastric anatomy who need an ERCP', 'timeFrame': 'approximately one week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopy assisted ERCP', 'altered gastric anatomy'], 'conditions': ['Biliary Disease', 'Pancreas Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery.', 'detailedDescription': 'Patients would have had a Roux-en-Y gastric bypass in the past that had altered their gastric anatomy. Now they have developed bilary and/or pancreatic problems that require and ERCP. With their altered gastric anatomy a standard ERCP would not be possible. Thus they are scheduled for a Laparoscopy-assisted ERCP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those patients who have altered gastric anatomy that require a laparoscopy assisted ERCP', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Altered gastric anatomy\n* Scheduled to undergo laparoscopy-assisted ERCP\n\nExclusion Criteria:\n\n* Any contraindications to performing endoscopy\n* Participation in another research protocol that could interfere or influence the outcomes measures of the present study.\n* The subject is unable/unwilling to give informed consent'}, 'identificationModule': {'nctId': 'NCT01620632', 'briefTitle': 'Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Prospective Evaluation of the Clinical Utility of Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatomy', 'orgStudyIdInfo': {'id': 'IRB201600462'}, 'secondaryIdInfos': [{'id': '511-2011', 'type': 'OTHER', 'domain': 'UF IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Altered gastric anatomy', 'description': 'Patients who have an altered gastric who need an ERCP', 'interventionNames': ['Procedure: Laparoscopy assisted ERCP']}], 'interventions': [{'name': 'Laparoscopy assisted ERCP', 'type': 'PROCEDURE', 'otherNames': ['Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'Roux-en-Y gastric bypass surgery', 'Laparoscopy'], 'description': 'Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.', 'armGroupLabels': ['Altered gastric anatomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Peter V Draganov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}