CholangiocarcinomaNCT06888401
Clinico-demographic Profile of the Patient With Pancreaticobiliary Malignancy Undergoing ERCP in a Tertiary Care Center of Nepal
An observational study of Cholangiocarcinoma and Bile Duct Carcinoma, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Bile Duct Carcinoma, Endoscopic Retrograde Cholangio-Pancreatography
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 597 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2017to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- those with suspected intrahepatic cholangiocarcinoma, who underwent percutaneous transhepatic cholangiography with biliary drainage
- Those with incomplete hospital records
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Kathmandu University School of Medical Sciences
Dhulikhel, Bagmati, 45210
About this study
Official title: 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.
- Conditions
- Cholangiocarcinoma, Bile Duct Carcinoma, Endoscopic Retrograde Cholangio-Pancreatography, Pancreatic Neoplasms
- Being tested
- ERCP
- Keywords
- Bile duct, Cholangiocarcinoma, Endoscopic Retrograde Cholangiopancreatography, Nepal, Pancreatic Neoplasm
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 years from January 2017 to January 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jan 2017
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prakash Sapkota, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888401
- Sponsor's protocol ID
- KUSMS-IRC (39/23)
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be available upon request from the analysis report.
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.
PubMed 33806458England 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.
PubMed 8994702Mumtaz 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.
PubMed 17636818
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinico-demographic Profile of the Patient With Pancreaticobiliary Malignancy Undergoing ERCP in a Tertiary Care Center of Nepal: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06888401
- Acronym / sponsor ID
- KUSMS-IRC (39/23)
- Conditions
- Cholangiocarcinoma, Bile Duct Carcinoma, Endoscopic Retrograde Cholangio-Pancreatography, Pancreatic Neoplasms
- Keywords
- Bile duct, Cholangiocarcinoma, Endoscopic Retrograde Cholangiopancreatography, Nepal, Pancreatic Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- those with suspected intrahepatic cholangiocarcinoma, who underwent percutaneous transhepatic cholangiography with biliary drainage
- Those with incomplete hospital records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP | Procedure or surgery | – |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 33806458Makar 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.
- Background: PubMed 8994702England 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.
- Background: PubMed 17636818Mumtaz 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.
- Individual participant dataSharing planned: No. Individual participant data will be available upon request from the analysis report.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Bile Duct Carcinoma, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of risk factors in patients with Pancreaticobiliary Malignancy (time frame: 6 years from January 2017 to January 2023.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06888401, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.