Multidetector Computed Tomography (MDCT) Evaluation of Obstructive Jaundice: A Cross-sectional Study From a Tertiary Hospital of Nepal

Sponsor

Shree Birendra Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05919303

Collaborator

BP Koirala Institute of Health Sciences (Other)

Enrollment

Location

12.1

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obstuctive Jaundice Radiological Correlation of Obstructive Jaundice	Radiation: CT Scan

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Multidetector Computed Tomography (MDCT) Evaluation of Obstructive Jaundice: A Cross-sectional Study From a Tertiary Hospital of Nepal

Actual Study Start Date :

Oct 8, 2019

Actual Primary Completion Date :

Oct 7, 2020

Actual Study Completion Date :

Oct 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patient presenting with obstructive jaundice referred for CT evaluation	Radiation: CT Scan CT scan study of abdomen

Arm

Intervention/Treatment

Patient presenting with obstructive jaundice referred for CT evaluation

Radiation: CT Scan

CT scan study of abdomen

Outcome Measures

Primary Outcome Measures

Evaluate the diagnostic statistics of MDCT and its features in the assessment of obstructive jaundice in reference to surgical or histopathological diagnosis. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any patient referred for CT scan with findings suggestive of obstructive jaundice with pertinent Histopathological and post-surgical findings .

Exclusion Criteria:

Patients with contraindications for contrast-enhanced CT, those with non-obstructive cases of jaundice, and patients experiencing recurrent malignancy causing obstructive jaundice.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BP Koirala Institute of Health Sciences	Dharān Bāzār	Koshi	Nepal

Sponsors and Collaborators

Shree Birendra Hospital
BP Koirala Institute of Health Sciences

Investigators

Principal Investigator: Asim Mahat, MD, Nepalese Army Institute of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asim Mahat, Doctor, Shree Birendra Hospital

ClinicalTrials.gov Identifier:

NCT05919303

Other Study ID Numbers:

Acd/291/075/076-IRC

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Jaundice

Jaundice, Obstructive

Study Results

No Results Posted as of Jun 26, 2023