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临床试验/NCT06327126
NCT06327126已完成不适用

Efficacy and Safety of Single-session Endoscopic Stone Extraction for Treating Acute Cholangitis Accompanied With Choledocholithiasis

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 563 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
563
试验地点
1
主要终点
Success rate of complete stone removal

研究概览

简要总结

This is a retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction.

详细描述

Acute cholangitis is an acute inflammation caused by obstruction of the bile duct, of which choledocholithiasis is the most common cause. Without timely removal of the obstruction or control of the infection, cholangitis can get worse and even become life-threatening. Therefore, timely and effective treatment is essential for patients with acute cholangitis combined with choledocholithiasis. Endoscopic retrograde cholangiography (ERCP) is used as the first-line treatment for choledocholithiasis-associated acute cholangitis. Previous guidelines recommended two-session endoscopic therapy. Endoscopic biliary drainage as the initial treatment, followed by endoscopic stone extraction after cholangitis improved. In recent years, studies have found that single-session endoscopic stone extraction is safe and effective for patients without serious organ function impairment. Meanwhile, single-session endoscopic lithotomy can avoid the second ERCP intervention, which can relieve the pain of patients, reduce medical costs and shorten the length of hospital stay. However, there is still insufficient evidence on the effectiveness and safety of early single-session ERCP lithotomy. The aim of this study is to evaluate the efficacy and safety of single-session endoscopic stone extraction for acute cholangitis associated with choledocholithiasis, so as to provide reference of clinical treatment.

In a retrospective analysis, approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital were studied. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years old
  • Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of acute cholangitis
  • Imaging examination confirmed the presence of choledocholithiasis
  • Patients received endoscopic single-session stone extraction or two-session treatment involving stone removal after drainage

排除标准

  • Common bile duct with benign or malignant stenosis
  • Changes in the anatomical structure of the stomach or duodenum
  • Patients complicated with severe acute pancreatitis
  • Patients who underwent endoscopic intervention before admission
  • Patients received percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions besides endoscopic treatment

结局指标

主要结局

Success rate of complete stone removal

时间窗: during the operation

Segmental angiography was performed by balloon closure to determine the presence or absence of negative stone shadow

ERCP-related complication rate

时间窗: from the operation to 1 month after the operation

The complications include pancreatitis, hemorrhage, perforation, pneumonia, etc. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination were measured.

次要结局

  • Hospital expenses(perioperatively)
  • Length of stay(perioperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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