Effectiveness and Safety of Single-session Endoscopic Stone Extraction

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

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.

Study Overview

• Status: Completed
• Conditions: Choledocholithiasis With Acute Cholangitis
• Intervention / Treatment: Procedure: two-session ERCP; Procedure: single-session ERCP

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single-session treatment group; single-session ERCP	Procedure: single-session ERCP; directly endoscopic stone extraction
Experimental: two-session treatment group; two-session ERCP	Procedure: two-session ERCP; early endoscopic drainage followed by endoscopic stone extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of complete stone removal	Segmental angiography was performed by balloon closure to determine the presence or absence of negative stone shadow	during the operation
ERCP-related complication rate	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.	from the operation to 1 month after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Total time from admission to discharge.	perioperatively
Hospital expenses	Total expenses from admission to discharge.	perioperatively

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Fujing Lv, M.D., Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Choledocholithiasis; Endoscopic Retrograde Cholangiopancreatography; Acute Cholangitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholelithiasis; Common Bile Duct Diseases; Cholangitis; Choledocholithiasis
• Other Study ID Numbers: BFHHZS20240064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No