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临床试验/NCT06900790
NCT06900790尚未招募不适用

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

Yifan Deng0 个研究点目标入组 60 人开始时间: 2025年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
stone clearance

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

stone clearance

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Yifan Deng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yifan Deng

M.Med

West China Second University Hospital

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