Effectiveness and Safety of Single-session Endoscopic Stone Extraction

NCT ID: NCT06349954

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-01-15

Brief Summary

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.

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.

Conditions

Choledocholithiasis With Acute Cholangitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-session treatment group

single-session ERCP

Group Type: EXPERIMENTAL

single-session ERCP

Intervention Type: PROCEDURE

directly endoscopic stone extraction

two-session treatment group

two-session ERCP

Group Type: EXPERIMENTAL

two-session ERCP

Intervention Type: PROCEDURE

early endoscopic drainage followed by endoscopic stone extraction

Interventions

single-session ERCP

directly endoscopic stone extraction

Intervention Type: PROCEDURE

two-session ERCP

early endoscopic drainage followed by endoscopic stone extraction

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fujing Lv, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BFHHZS20240064

Identifier Type: -

Identifier Source: org_study_id