NCT05919303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 16, 2023

Last Update Submit

June 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

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

    one year

Study Arms (1)

Patient presenting with obstructive jaundice referred for CT evaluation

Radiation: CT Scan

Interventions

CT ScanRADIATION

CT scan study of abdomen

Patient presenting with obstructive jaundice referred for CT evaluation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BP Koirala Institute of Health Sciences

Dharān, Koshi, Nepal

Location

Study Officials

  • Asim Mahat, MD

    Nepalese Army Institute of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 16, 2023

First Posted

June 26, 2023

Study Start

October 8, 2019

Primary Completion

October 7, 2020

Study Completion

October 10, 2020

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations