Effectiveness and Safety of Single-session Endoscopic Stone Extraction

NCT06349954 | Completed

• 1 other identifier: BFHHZS20240064
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Choledocholithiasis With Acute Cholangitis

Keywords

Acute Cholangitis; Endoscopic Retrograde Cholangiopancreatography; Choledocholithiasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Length of stay

  perioperatively

• Hospital expenses

  perioperatively

Study Arms (2)

single-session treatment group

EXPERIMENTAL

single-session ERCP

Procedure: single-session ERCP

two-session treatment group

EXPERIMENTAL

two-session ERCP

Procedure: two-session ERCP

Interventions

single-session ERCP PROCEDURE

directly endoscopic stone extraction

single-session treatment group

two-session ERCP PROCEDURE

early endoscopic drainage followed by endoscopic stone extraction

two-session treatment group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Study Officials

• Fujing Lv, M.D.

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will be randomly allocated into single-session group or two-session group.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: April 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 15, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-01

Locations

CN (1)