Management of Pediatric Pancreatic Calculi At a Single Center: a Retrospective Cohort Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorYifan Deng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
ERCP
Procedure/SurgeryThere 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ERCP group1 intervention
Group B: Surgery group1 intervention
Trial outcomes
Primary outcomes
1
stone clearance
The stone clearance rate refers to the proportion of patients confirmed by postoperative imaging (MRCP) to have no residual pancreatic duct stones.
Time frame
From intervention to the end of treatment at 1 week2
complication rate
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.
Time frame
From enrollment to the end of treatment at 2 weeks3
reintervention rate
The reintervention rate refers to the proportion of patients who required additional invasive procedures (either ERCP or surgery) after the initial treatment.
Time frame
From enrollment to the end of treatment at 1 year.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yifan Deng
Lead sponsor
West China Second University Hospital
Sponsor institution
Source ClinicalTrials.gov
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