Clinico-demographic Profile Of The Patient With Pancreaticobiliary Malignancy Undergoing ERCP In A Tertiary Care Center Of Nepal

Study Overview

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

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.

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Cholangiocarcinoma
Bile Duct Carcinoma
Endoscopic Retrograde Cholangio-Pancreatography
Pancreatic Neoplasms

PROCEDURE: ERCP

KUSMS-IRC (39/23)

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-03-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-20
First Submitted that Met QC Criteria 2025-03-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-21
First Posted (ACTUAL) 2025-03-21	Results First Posted N/A	Last Verified 2025-03

Study Plan

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

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Measurement of risk factors in patients with Pancreaticobiliary Malignancy	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	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	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.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Publications

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

General Publications

Makar M, Zhao E, Tyberg A. Personalized Approach to the Role of Endoscopic Ultrasound in the Diagnosis and Management of Pancreaticobiliary Malignancies. J Pers Med. 2021 Mar 4;11(3):180. doi: 10.3390/jpm11030180.
England RE, Martin DF. Endoscopic and percutaneous intervention in malignant obstructive jaundice. Cardiovasc Intervent Radiol. 1996 Nov-Dec;19(6):381-7. doi: 10.1007/BF02577624.
Mumtaz K, Hamid S, Jafri W. Endoscopic retrograde cholangiopancreaticography with or without stenting in patients with pancreaticobiliary malignancy, prior to surgery. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD006001. doi: 10.1002/14651858.CD006001.pub2.

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