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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06327126
Enrollment
563
Registered
2024-03-25
Start date
2024-01-01
Completion date
2024-07-01
Last updated
2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis With Acute Cholangitis

Keywords

Choledocholithiasis, Acute Cholangitis, Endoscopic Retrograde Cholangiopancreatography

Brief summary

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

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.

Interventions

early endoscopic drainage followed by endoscopic stone extraction

directly endoscopic stone extraction

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate of complete stone removalduring the operationSegmental angiography was performed by balloon closure to determine the presence or absence of negative stone shadow
ERCP-related complication ratefrom the operation to 1 month after the operationThe 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

MeasureTime frameDescription
Length of stayperioperativelyTotal time from admission to discharge.
Hospital expensesperioperativelyTotal expenses from admission to discharge.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026