Clinical trial NCT06888401: Clinico-demographic Profile of the Patient With Pancreaticobiliary Malignancy Undergoing ERCP in a Tertiary Care Center of Nepal
Official title: Clinico-demographic Profile of the Patient With Pancreaticobiliary Malignancy Undergoing ERCP in a Tertiary Care Center of Nepal: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangiocarcinoma
Bile Duct Carcinoma
Endoscopic Retrograde Cholangio-Pancreatography
Pancreatic Neoplasms
Keywords: Bile duct
Cholangiocarcinoma
Endoscopic Retrograde Cholangiopancreatography
Nepal
Pancreatic Neoplasm
Lead sponsor: Kathmandu University School of Medical Sciences
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 597
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of risk factors in patients with Pancreaticobiliary Malignancy
timeFrame: 6 years from January 2017 to January 2023.
measure: Measurement of clinical patterns in patients with Pancreaticobiliary Malignancy
timeFrame: 6 years from January 2017 to January 2023.
measure: Measurement of treatment modalities in patients with Pancreaticobiliary Malignancy
timeFrame: 6 years from January 2017 to January 2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Dhulikhel
country: Nepal
facility: Kathmandu University School of Medical Sciences
state: Bagmati
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.