Clinical trial NCT06327126: Efficacy and Safety of Single-session Endoscopic Stone Extraction
Official title: Efficacy and Safety of Single-session Endoscopic Stone Extraction for Treating Acute Cholangitis Accompanied With Choledocholithiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis With Acute Cholangitis
Keywords: Choledocholithiasis
Acute Cholangitis
Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 563
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate of complete stone removal
timeFrame: during the operation
measure: ERCP-related complication rate
timeFrame: from the operation to 1 month after the operation
Secondary outcomes:
measure: Length of stay
timeFrame: perioperatively
measure: Hospital expenses
timeFrame: perioperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Fujing Lv, M.D.
role: PRINCIPAL_INVESTIGATOR
References: