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

NCT06900790 | Not Yet Recruiting DMC

• 1 other identifier: Ethical No. 2024 Review (35)
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Duct Stenting; ERCP; Surgery in Early Childhood; Pediatric Surgery

Keywords

pancreatic duct stones; ERCP; Frey surgery

Outcome Measures

Primary Outcomes (3)

• stone clearance

  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

  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

  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.

Study Arms (2)

ERCP group

Pediatric pancreatic duct stone patients who underwent ERCP to restore pancreatic duct patency.

Procedure: ERCP

Surgery group

Pediatric pancreatic duct stone patients who underwent Frey surgery.

Procedure: ERCP

Interventions

ERCP PROCEDURE

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).

Also known as: Frey surgery

ERCP group; Surgery group

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yifan Deng: lead

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.Med

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: April 23, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03