Effectiveness and Safety of Single-session Endoscopic Stone Extraction

Not Applicable

Recruiting

• Conditions: Choledocholithiasis With Acute Cholangitis
• Interventions: Procedure: single-session ERCP; Procedure: two-session ERCP

• Registration Number: NCT06349954
• Lead Sponsor: Beijing Friendship Hospital

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Study Start: 2024-04-15
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single-session treatment group	single-session ERCP	single-session ERCP
two-session treatment group	two-session ERCP	two-session ERCP

Primary Outcome Measures

Name	Time	Method
Success rate of complete stone removal	during the operation	Segmental angiography was performed by balloon closure to determine the presence or absence of negative stone shadow
ERCP-related complication rate	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 Outcome Measures

Name	Time	Method
Length of stay	perioperatively	Total time from admission to discharge.
Hospital expenses	perioperatively	Total expenses from admission to discharge.

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China