Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-28 @ 10:22 AM
Study NCT ID:
NCT01321203
Status:
COMPLETED
Last Update Posted:
2011-07-19
First Post:
2011-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041781', 'term': 'Jaundice, Obstructive'}], 'ancestors': [{'id': 'D007565', 'term': 'Jaundice'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-16', 'studyFirstSubmitDate': '2011-01-28', 'studyFirstSubmitQcDate': '2011-03-22', 'lastUpdatePostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient comfort post ERCP', 'timeFrame': '1 hour', 'description': 'the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )'}], 'secondaryOutcomes': [{'measure': 'Abdominal distention prior and post ERCP', 'timeFrame': '5 minutes', 'description': 'The abdominal girth was measured prior to patient shifted to ERCP table. The immdiately post ERCP the abdominal girth measured. A fixed point is marked at the umblical regiem to maintain the site of abdominal girth.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['carbon dioxide insufflation'], 'conditions': ['Obstructive Jaundice']}, 'descriptionModule': {'briefSummary': "To assess the safety and efficacy of CO2 insufflations during ERCP\n\n1. Primary objective:\n\n To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.\n2. Secondary objective:\n\nEndoscopist:\n\n* To assess the adequacy of bowel distension for adequate luminal visualization\n* To assess the peristaltic movement during the ERCP\n\nAnesthetist:\n\n* To measure the PCO2 level in patient post procedure.\n* To assess the amount of sedation required during the procedure.\n* To assess saturation and vital signs through out the procedure.\n* To assess requirement of buscopan.", 'detailedDescription': 'mentioned in complete'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population age group 18yrs and above', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive adult patients referred for ERCP to AIG Hyderabad\n\nExclusion Criteria:\n\n* Age \\< 18 years old excluded from the study.\n* Patients with COPD.\n* Patients with poor ejection fractions and decompensated heart failure.\n* Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments.\n* Patients with recent endoscopic procedure within 24 hours.\n* Patient with history of recent surgery within 7 days of duration.\n* Pregnant patients.\n* Patients not keen to give consent for the study.'}, 'identificationModule': {'nctId': 'NCT01321203', 'briefTitle': 'Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).', 'orgStudyIdInfo': {'id': 'AIG-GI2010-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group-A, use of air;'}, {'label': 'Group-B use of CO2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '500082', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Asian Institute Of Gastroenterology India'}], 'overallOfficials': [{'name': 'Saravanan Arjuanan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asian Institute of Gastroenterology, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'DR A. Saravanan Arjunan', 'oldOrganization': 'Asian Institute of Gastroenterology, India'}}}}