Efficacy and Safety of Single-session Endoscopic Stone Extraction

Efficacy and Safety of Single-session Endoscopic Stone Extraction for Treating Acute Cholangitis Accompanied With Choledocholithiasis

This is a retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction.

Study Overview

• Status: Recruiting
• 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 retrospective analysis, approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital were studied. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Wei Jiang, Ph.D; Phone Number: 18663186116; Email: jfw899w@outlook.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Wei Jiang; Phone Number: 18663186116; Email: jfw899w@outlook.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed with acute cholangitis associated with choledocholithiasis underwent single-session stone extraction or two-session treatment involving stone removal after drainage at Beijing Friendship Hospital.

Description

Inclusion Criteria:

1. Age ≥18 years old
2. Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of acute cholangitis
3. Imaging examination confirmed the presence of choledocholithiasis
4. Patients received endoscopic single-session stone extraction or two-session treatment involving stone removal after drainage

Exclusion Criteria:

1. Common bile duct with benign or malignant stenosis
2. Changes in the anatomical structure of the stomach or duodenum
3. Patients complicated with severe acute pancreatitis
4. Patients who underwent endoscopic intervention before admission
5. Patients received percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions besides endoscopic treatment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
two-session treatment group; two-session ERCP	Procedure: two-session ERCP; early endoscopic drainage followed by endoscopic stone extraction
single-session treatment group; single-session ERCP	Procedure: single-session ERCP; directly 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): January 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: March 1, 2024

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; Common Bile Duct Diseases; Cholelithiasis; Cholangitis; Choledocholithiasis
• Other Study ID Numbers: BFHHZS20240001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No