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

June 16, 2023 updated by: Asim Mahat, Shree Birendra Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Koshi
      • Dharān Bāzār, Koshi, Nepal
        • BP Koirala Institute of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the diagnostic statistics of MDCT and its features in the assessment of obstructive jaundice in reference to surgical or histopathological diagnosis.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shree Birendra Hospital

Collaborators

BP Koirala Institute of Health Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Actual)

October 7, 2020

Study Completion (Actual)

October 10, 2020

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acd/291/075/076-IRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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