Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-28 @ 6:29 AM
Study NCT ID:
NCT03599492
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2018-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis', 'timeFrame': '14 Weeks', 'description': 'Due to small sample size, Wilcoxon rank-sum test will be used to compare the continuous variable of gut transit times. A p-value of \\<0.05 will be considered statistically significant.'}, {'measure': 'Post TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis', 'timeFrame': '14 Weeks', 'description': 'Due to small sample size, Wilcoxon rank-sum test will be used to compare the continuous variable of gut transit times. A p-value of \\<0.05 will be considered statistically significant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut Microflora', 'Transjugular Intraheptic Portosystemic Shunting'], 'conditions': ['Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The effect of portal hypertension on gastrointestinal motility, and how reversal or improvement in portal hypertension may alter gastrointestinal motility, remains unclear and further research is needed. Additionally, patients with cirrhosis have altered gut microflora, particularly rich in lactobacilli, including enterococci and bifidobacteria. Transjugular Intraheptic Portosystemic Shunting (TIPS) is a procedure performed by interventional radiologists, in which a connection is made between the portal and venous circulations, allowing high pressure portal blood to more easily enter the systemic circulation and bypass the liver; thus effectively decreased portal pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '10 patients recruited from NYU Langone Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with either radiographic or biopsy proven decompensated cirrhosis (as determined by ascites, variceal hemorrhage, encephalopathy or jaundice).\n* Patients undergoing an elective TIPS for any standard of care established indication (examples: worsening ascites, recurrent variceal bleeding).\n\nExclusion Criteria:\n\n* Pregnant women.\n* Patients unwilling or unable to provide informed consent.\n* Patients undergoing an emergent TIPS for acute or subacute variceal hemorrhage.\n* Patients with diabetes, significant cardiovascular, renal or other chronic disease which has been known to affect intestinal motility.\n* Previously diagnosed gastroparesis or other GI dysmotility disorder.\n* Patients currently taking narcotics, antibiotics excluding rifaximin, prokinetic medications or lactulose.\n* Patients with a history of gastric bezoar.\n* Patients with a history of multiple intestinal surgeries or GI surgery within the past 3 months.\n* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.\n* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.\n* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.\n* Patients with a history of diverticulitis.\n* Patients with swallowing disorders and increased risk of aspiration (such as prior history of aspiration).\n* Patient with Celiac disease.\n* Patients with implanted or portable electro-mechanical medical devices.'}, 'identificationModule': {'nctId': 'NCT03599492', 'briefTitle': 'The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota', 'orgStudyIdInfo': {'id': '16-01360'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cirrhosis Patients', 'description': '10 Patients with body mass index (BMI) etiology of cirrhosis', 'interventionNames': ['Diagnostic Test: SMART Pill Pre-TIPS', 'Diagnostic Test: SMART Pill Post TIPS']}], 'interventions': [{'name': 'SMART Pill Pre-TIPS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies', 'armGroupLabels': ['Cirrhosis Patients']}, {'name': 'SMART Pill Post TIPS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies', 'armGroupLabels': ['Cirrhosis Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bedros Taslakian, MD, EBIR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}