Clinico-demographic Profile of the Patient With Pancreaticobiliary Malignancy Undergoing ERCP in a Tertiary Care Center of Nepal

March 20, 2025 updated by: Prakash Sapkota, Kathmandu University School of Medical Sciences

Clinico-demographic Profile of the Patient With Pancreaticobiliary Malignancy Undergoing ERCP in a Tertiary Care Center of Nepal: A Cross-sectional Study

Background Pancreaticobiliary malignancy (PBM) is a group of cancers affecting pancreas and bile duct. The diagnosis is often late and with fatal outcomes. Here, investigators study the clinicodemographic profile of the patients with suspected PBM undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) at a tertiary care center in Nepal.

Material and Methods Retrospectively, a descriptive cross-sectional study was conducted at the endoscopy unit of the Internal medicine department of Dhulikhel Hospital-Kathmandu University Hospital (DH-KUH) from Jan 2017 to Jan 2023. Patients over 18 years of age with suspected PBM with complete medical records who underwent ERCP were included in our study. The descriptive and correlation statistics were done.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

597

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
    • Bagmati
      • Dhulikhel, Bagmati, Nepal, 45210
        • Kathmandu University School of Medical 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Total population sampling was performed from the medical records of patients fulfilling the inclusion criteria. All the eligible cases that were listed in the medical record of Dhulikhel Hospital from January 2017 to January 2023 were obtained manually. The tally considered patients undergoing multiple ERCP procedures as a single case.

Description

Inclusion Criteria:

  • above 18years of age.
  • those with confirmed pancreaticobiliary malignancies, diagnosed through histopathology from ERCP, or Endoscopic Ultrasound (EUS), or Computerized tomography (CT) guided biopsy, and who underwent ERCP
  • those with strong suspicions of malignancy confirmed by clinical, CT scan and ERCP findings, and who also underwent ERCP

Exclusion Criteria:

  • those with suspected intrahepatic cholangiocarcinoma, who underwent percutaneous transhepatic cholangiography with biliary drainage
  • Those with incomplete hospital records

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of risk factors in patients with Pancreaticobiliary Malignancy
Time Frame: 6 years from January 2017 to January 2023.
The risk factors will be assessed on the basis of physiological parameters like age, dietary habits, smoking and alcohol habits and comorbities.
6 years from January 2017 to January 2023.
Measurement of clinical patterns in patients with Pancreaticobiliary Malignancy
Time Frame: 6 years from January 2017 to January 2023.
The clinical patterns will be assessed on the basis of data collected from self-structured proforma that was used as research tool for data collection based on literature review. The patient information was obtained from hospital records after informed consent.
6 years from January 2017 to January 2023.
Measurement of treatment modalities in patients with Pancreaticobiliary Malignancy
Time Frame: 6 years from January 2017 to January 2023.
The treatment modalities will be assessed with a self-structured proforma which will include the type of treatment modalities like surgical or medical or combined, and the the choice of stent type and technical success of type of stents.
6 years from January 2017 to January 2023.

Collaborators and Investigators

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

Sponsor

Kathmandu University School of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2017

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUSMS-IRC (39/23)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will be available upon request from the analysis report.

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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