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Completed

NCT Number: NCT06349954

Effectiveness and Safety of Single-session Endoscopic Stone Extraction

This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

About this study

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 prospective study, approximately 64 patients with acute cholangitis accompanied with choledocholithiasis will be involved. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Age ≥18 years old and ≤90 years old
  • 2. Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of Grade I or Grade II acute cholangitis
  • 3. Imaging examination confirmed the presence of choledocholithiasis

Exclusion criteria

  • 1. Common bile duct with benign or malignant stenosis
  • 2. Changes in the anatomical structure of the stomach or duodenum
  • 3. Patients with common biliary duct or pancreatic duct stent
  • 4. Patients complicated with acute pancreatitis
  • 5. Patients who underwent endoscopic intervention, percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions before admission
  • 6. Patients with cardiac failure, respiratory failure or consciousness disorder can not tolerate endoscopic operation
  • 7. Patients who have coagulation dysfunction or are taking anticoagulation and antiplate drugs
  • 8. Imaging examination showed that the maximum diameter of choledocholithiasis was more than 1.5cm

Treatment and study plan

single-session ERCP

Procedure

directly endoscopic stone extraction

two-session ERCP

Procedure

early endoscopic drainage followed by endoscopic stone extraction

Primary outcomes

  1. Success rate of complete stone removal

    Time frame: during the operation

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

  2. ERCP-related complication rate

    Time frame: 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.

Secondary outcomes

  1. Length of stay

    Time frame: perioperatively

    Total time from admission to discharge.

  2. Hospital expenses

    Time frame: perioperatively

    Total expenses from admission to discharge.

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

Effectiveness and Safety of Single-session Endoscopic Stone Extraction for Acute Cholangitis Associated With Choledocholithiasis

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
Jun 24, 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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