Post-ERCP PancreatitisNCT07125014
Frequency and Predictors of Post-ERCP Pancreatitis in a South Asian Tertiary Care Center
An observational study of Post-ERCP Pancreatitis, run by Nangarhar University at 1 site in Pakistan.
Trial summary
This study was conducted at the Department of Gastroenterology, Lady Reading Hospital, Peshawar, Pakistan, from January 2023 to December 2023. It aimed to determine how often patients develop pancreatitis (inflammation of the pancreas) after undergoing a procedure called endoscopic retrograde cholangiopancreatography… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- Observational study
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 31 Dec 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: Adult patients undergoing ERCP at the Department of Gastroenterology, Lady Reading Hospital, Peshawar, between January 2023 and December 2023.
Who may be able to join
- Known chronic pancreatitis
- Pancreatic malignancy
- Pre-existing acute pancreatitis
- Incomplete procedural or laboratory records
Who cannot join
- Known chronic pancreatitis
- Pancreatic malignancy
- Pre-existing acute pancreatitis
- Incomplete procedural or laboratory records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency and Risk Factors of Post-ERCP Pancreatitis: A Single-Center Experience From South Asia
This study was conducted at the Department of Gastroenterology, Lady Reading Hospital, Peshawar, Pakistan, from January 2023 to December 2023. It aimed to determine how often patients develop pancreatitis (inflammation of the pancreas) after undergoing a procedure called endoscopic retrograde cholangiopancreatography (ERCP), and to identify the main factors that increase this risk. We reviewed the medical records of 300 adult patients who had ERCP for various conditions, such as bile duct stones, tumors, and strictures. We assessed patient characteristics, procedure details, and laboratory results to see which factors were linked to post-ERCP pancreatitis. The study found that prolonged cannulation time, injection of contrast into the pancreatic duct, and high levels of C-reactive protein before the procedure were the strongest predictors of this complication. These findings may help doctors identify high-risk patients and take preventive steps to reduce the chances of pancreatitis after ERCP.
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- Observational study
- Keywords
- Endoscopic retrograde cholangiopancreatography, ERCP complications, Pancreatitis risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyProcedure or surgery
This is an observational study with no experimental or therapeutic interventions administered to participants. All data were collected retrospectively from existing hospital records for patients who underwent ERCP between January 2023 and December 2023 at Lady Reading Hospital, Peshawar. No drugs, devices, or procedures were assigned to participants as part of this research.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-ERCP Pancreatitis
The number and proportion of patients developing post-ERCP pancreatitis (PEP), defined as new or worsened abdominal pain with serum amylase or lipase levels ≥3 times the upper limit of normal within 24 hours after ERCP, requiring hospitalization or prolongation of hospital stay.
Measured: Within 24 hours after ERCP and during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Jan 2023
- Primary completion14 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP PancreatitisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nangarhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafiullah Hotak, Nangarhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125014
- Sponsor's protocol ID
- Ref: No.1027/LRH/MTI
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Risk Factors of Post-ERCP Pancreatitis: A Single-Center Experience From South Asia
- ClinicalTrials.gov ID
- NCT07125014
- Acronym / sponsor ID
- Ref: No.1027/LRH/MTI
- Conditions
- Post-ERCP Pancreatitis
- Keywords
- Endoscopic retrograde cholangiopancreatography, ERCP complications, Pancreatitis risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Nangarhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Aug 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.
This study was conducted at the Department of Gastroenterology, Lady Reading Hospital, Peshawar, Pakistan, from January 2023 to December 2023. It aimed to determine how often patients develop pancreatitis (inflammation of the pancreas) after undergoing a procedure called endoscopic retrograde cholangiopancreatography (ERCP), and to identify the main factors that increase this risk. We reviewed the medical records of 300 adult patients who had ERCP for various conditions, such as bile duct stones, tumors, and strictures. We assessed patient characteristics, procedure details, and laboratory results to see which factors were linked to post-ERCP pancreatitis. The study found that prolonged cannulation time, injection of contrast into the pancreatic duct, and high levels of C-reactive protein before the procedure were the strongest predictors of this complication. These findings may help doctors identify high-risk patients and take preventive steps to reduce the chances of pancreatitis after ERCP.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing ERCP at the Department of Gastroenterology, Lady Reading Hospital, Peshawar, between January 2023 and December 2023.
Key inclusion criteria (4 listed)
- Known chronic pancreatitis
- Pancreatic malignancy
- Pre-existing acute pancreatitis
- Incomplete procedural or laboratory records
Key exclusion criteria (4 listed)
- Known chronic pancreatitis
- Pancreatic malignancy
- Pre-existing acute pancreatitis
- Incomplete procedural or laboratory 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 |
|---|---|---|
| Observational studyThis is an observational study with no experimental or therapeutic interventions administered to participants. All data were collected retrospectively from existing hospital records for patients who underwent ERCP between January 2023 and December 2023 at Lady Reading Hospital, Peshawar. No drugs, devices, or procedures were assigned to participants as part of this research. | Procedure or surgery | – |
Primary outcome
Incidence of Post-ERCP Pancreatitis
Time frame: Within 24 hours after ERCP and during hospitalization
The number and proportion of patients developing post-ERCP pancreatitis (PEP), defined as new or worsened abdominal pain with serum amylase or lipase levels ≥3 times the upper limit of normal within 24 hours after ERCP, requiring hospitalization or prolongation of hospital stay.
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 15 Aug 2025.
- Individual participant dataSharing planned: No
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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 Post-ERCP Pancreatitis, run by Nangarhar University at 1 site in Pakistan.
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 4 inclusion and 4 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 15 Aug 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 Pakistan. 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?
Incidence of Post-ERCP Pancreatitis (time frame: Within 24 hours after ERCP and during hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.