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

NCT06888401 | Completed DMC

• 1 other identifier: KUSMS-IRC (39/23)
• Study Type: observational
• Target: 597
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholangiocarcinoma; Bile Duct Carcinoma; Endoscopic Retrograde Cholangio-Pancreatography; Pancreatic Neoplasms

Keywords

Bile duct; Cholangiocarcinoma; Endoscopic Retrograde Cholangiopancreatography; Nepal; Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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.

Interventions

ERCP PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Study Sites (1)

Kathmandu University School of Medical Sciences

Dhulikhel, Bagmati, 45210, Nepal

Location

Related Publications (3)

• 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.

  PMID: 33806458 BACKGROUND

• 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.

  PMID: 8994702 BACKGROUND

• 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.

  PMID: 17636818 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma; Bile Duct Neoplasms; Pancreatic Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 21, 2025
• Study Start: January 1, 2017
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)