Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-04 @ 3:39 AM
Study NCT ID:
NCT05919303
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidetector Computed Tomography (MDCT) Evaluation of Obstructive Jaundice: A Cross-sectional Study From a Tertiary Hospital of Nepal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the diagnostic statistics of MDCT and its features in the assessment of obstructive jaundice in reference to surgical or histopathological diagnosis.', 'timeFrame': 'one year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstuctive Jaundice', 'Radiological Correlation of Obstructive Jaundice']}, 'descriptionModule': {'briefSummary': 'This study was done to evaluate the diagnostic statistics of MDCT and its features in the assessment of obstructive jaundice in reference to surgical or histopathological diagnosis.', 'detailedDescription': 'We did a cross-sectional study among 30 participants of obstructive jaundice at BP Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal. The sensitivity and the Negative predictive value of MDCT for non-neoplastic cause to detect obstructive jaundice were 100% (95% CI 79.41-100.00) and 100% (95% CI 75.29-100.00), while the specificity and the Positive predictive value for neoplastic cause to detect obstructive jaundice were 100% (95% CI: 79.41-100.00) and 100% (95% CI: 75.29-100.00). Similarly, the accuracy for either non-neoplastic or neoplastic cause was 96.67% (95% CI: 82.78-99.92). The most common cause for obstructive jaundice was choledocholithiasis (33.34%) followed by cholangiocarcinoma (20%), ampullary carcinoma (13.33%) and choledochal cyst (13.33%). The diagnostic accuracy of individual etiology of common causes of obstructive jaundice ranged from 82.78 to 100%. Biliary obstruction was most frequently observed in the periampullary region (83.33%), followed by the proximal common bile duct (6.67%), hilar region (6.67%), and intrahepatic region (3.33%).The MDCT could serve as the initial, cost-effective, easily available, and time-efficient imaging modality for diagnosing various causes of obstructive jaundice. It can differentiate non-neoplastic from neoplastic causes of obstructive jaundice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 All patients exhibiting clinical and biochemical features of obstructive jaundice who were referred for MDCT scan and subsequently received a final diagnosis through histopathology, cytopathology or surgical findings were included as participants in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient referred for CT scan with findings suggestive of obstructive jaundice with pertinent Histopathological and post-surgical findings .\n\nExclusion Criteria:\n\n* Patients with contraindications for contrast-enhanced CT, those with non-obstructive cases of jaundice, and patients experiencing recurrent malignancy causing obstructive jaundice.'}, 'identificationModule': {'nctId': 'NCT05919303', 'briefTitle': 'Multidetector Computed Tomography (MDCT) Evaluation of Obstructive Jaundice: A Cross-sectional Study From a Tertiary Hospital of Nepal', 'organization': {'class': 'OTHER', 'fullName': 'Shree Birendra Hospital'}, 'officialTitle': 'Multidetector Computed Tomography (MDCT) Evaluation of Obstructive Jaundice: A Cross-sectional Study From a Tertiary Hospital of Nepal', 'orgStudyIdInfo': {'id': 'Acd/291/075/076-IRC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient presenting with obstructive jaundice referred for CT evaluation', 'interventionNames': ['Radiation: CT Scan']}], 'interventions': [{'name': 'CT Scan', 'type': 'RADIATION', 'description': 'CT scan study of abdomen', 'armGroupLabels': ['Patient presenting with obstructive jaundice referred for CT evaluation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dharān', 'state': 'Koshi', 'country': 'Nepal', 'facility': 'BP Koirala Institute of Health Sciences', 'geoPoint': {'lat': 26.81436, 'lon': 87.27972}}], 'overallOfficials': [{'name': 'Asim Mahat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nepalese Army Institute of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shree Birendra Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'B.P. Koirala Institute of Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Asim Mahat', 'investigatorAffiliation': 'Shree Birendra Hospital'}}}}