Efficacy and Safety of Single-session Endoscopic Stone Extraction

Capital Medical University

Status: Completed

Conditions: Choledocholithiasis With Acute Cholangitis

Treatments: Procedure: single-session ERCP; Procedure: two-session ERCP

Study type: Observational

Funder types: Other

Identifiers

NCT06327126

BFHHZS20240001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 563 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

563 participants in 2 patient groups

two-session treatment group

Description:

two-session ERCP

Treatment:

Procedure: two-session ERCP

single-session treatment group

Description:

single-session ERCP

Treatment:

Procedure: single-session ERCP