NCT07125014

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

August 9, 2025

Last Update Submit

August 9, 2025

Conditions

Keywords

Endoscopic retrograde cholangiopancreatographyERCP complicationsPancreatitis risk factors

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 24 hours after ERCP and during hospitalization

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing ERCP at the Department of Gastroenterology, Lady Reading Hospital, Peshawar, between January 2023 and December 2023.

You may qualify if:

  • Known chronic pancreatitis
  • Pancreatic malignancy
  • Pre-existing acute pancreatitis
  • Incomplete procedural or laboratory records

You may not qualify if:

  • Known chronic pancreatitis
  • Pancreatic malignancy
  • Pre-existing acute pancreatitis
  • Incomplete procedural or laboratory records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LRH/MTI

Peshawar, KPK, Pakistan

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 9, 2025

First Posted

August 15, 2025

Study Start

January 1, 2023

Primary Completion

December 14, 2023

Study Completion

December 31, 2023

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations