Management of Pediatric Pancreatic Calculi At a Single Center: a Retrospective Cohort Study

March 23, 2025 updated by: Yifan Deng

A Single-Center Retrospective Cohort Study Evaluating the Management and Outcomes of Pediatric Pancreatic Duct Stones Using Endoscopic and Surgical Techniques

The goal of this observational study is to evaluate the long-term effects of ERCP and surgery in pediatric patients with pancreatic duct stones. The main objective is to determine the optimal treatment choice(ERCP or surgery) for children with pancreatic duct stones and identify the appropriate timing for surgery in patients who have undergone multiple ERCP procedures, in order to avoid adverse outcomes caused by repeated trauma to the duodenal papilla.

Last updated on January 24, 2025.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents (≤18 years old) diagnosed with pancreatic duct stones between 2015 and 2025 at a single tertiary care center. Data includes patients who underwent ERCP or surgery when the first treatment.

Description

Inclusion Criteria:

  • Patients aged 0 to 18 years
  • Diagnosed with pancreatic duct stones by imaging (e.g., ultrasound, CT, MRCP)
  • Treated and followed at pediatric surgery, west china hospital, between 2014 and 2025
  • Complete clinical data available for review

Exclusion Criteria:

  • Pancreatic duct stones secondary to previous pancreatic or biliary surgery
  • Concurrent severe systemic diseases (e.g., advanced cardiac, renal, or hepatic disease)
  • Incomplete or missing key clinical records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ERCP group
Pediatric pancreatic duct stone patients who underwent ERCP to restore pancreatic duct patency.
Procedure: ERCP
There are two intervention methods for pediatric pancreatic duct stones. One is to remove the pancreatic duct stones through Endoscopic Retrograde Cholangiopancreatography(ERCP), while simultaneously dilating the pancreatic duct and placing a stent to assist in the normal drainage of pancreatic juice. The other is local resection of the pancreatic head combined with longitudinal pancreaticojejunostomy (Frey surgery).
Other Names:
  • Frey surgery
Surgery group
Pediatric pancreatic duct stone patients who underwent Frey surgery.
Procedure: ERCP
There are two intervention methods for pediatric pancreatic duct stones. One is to remove the pancreatic duct stones through Endoscopic Retrograde Cholangiopancreatography(ERCP), while simultaneously dilating the pancreatic duct and placing a stent to assist in the normal drainage of pancreatic juice. The other is local resection of the pancreatic head combined with longitudinal pancreaticojejunostomy (Frey surgery).
Other Names:
  • Frey surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone clearance
Time Frame: From intervention to the end of treatment at 1 week
The stone clearance rate refers to the proportion of patients confirmed by postoperative imaging (MRCP) to have no residual pancreatic duct stones.
From intervention to the end of treatment at 1 week
complication rate
Time Frame: From enrollment to the end of treatment at 2 weeks
The complication rate refers to the incidence of pancreatitis following ERCP and associated procedures, as well as pancreatic fistula, bile leakage, and the necessity for prolonged drainage after the Frey procedure.
From enrollment to the end of treatment at 2 weeks
reintervention rate
Time Frame: From enrollment to the end of treatment at 1 year.
The reintervention rate refers to the proportion of patients who required additional invasive procedures (either ERCP or surgery) after the initial treatment.
From enrollment to the end of treatment at 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yifan Deng

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 23, 2025

Primary Completion (Estimated)

December 23, 2025

Study Completion (Estimated)

December 23, 2025

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ethical No. 2024 Review (35)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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