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NCT Number: NCT06900790

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

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.

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Key information

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Frey surgery

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Yifan Deng

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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