Efficacy and Safety of Single-session Endoscopic Stone Extraction

NCT ID: NCT06327126

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

563 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Choledocholithiasis With Acute Cholangitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

two-session treatment group

two-session ERCP

two-session ERCP

Intervention Type PROCEDURE

early endoscopic drainage followed by endoscopic stone extraction

single-session treatment group

single-session ERCP

single-session ERCP

Intervention Type PROCEDURE

directly endoscopic stone extraction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

two-session ERCP

early endoscopic drainage followed by endoscopic stone extraction

Intervention Type PROCEDURE

single-session ERCP

directly endoscopic stone extraction

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fujing Lv, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BFHHZS20240001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.