A Single-Center Retrospective Cohort Study Evaluating the Management and Outcomes of Pediatric Pancreatic Duct Stones Using Endoscopic and Surgical Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- stone clearance
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 2 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yifan Deng
M.Med
West China Second University Hospital