Clinical trial NCT06349954: Effectiveness and Safety of Single-session Endoscopic Stone Extraction
Official title: Effectiveness and Safety of Single-session Endoscopic Stone Extraction for Acute Cholangitis Associated With Choledocholithiasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Choledocholithiasis With Acute Cholangitis
Keywords: Acute Cholangitis
Endoscopic Retrograde Cholangiopancreatography
Choledocholithiasis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will be randomly allocated into single-session group or two-session group.
Primary purpose: TREATMENT

Brief summary: This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session 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 prospective study, approximately 64 patients with acute cholangitis accompanied with choledocholithiasis will be involved. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.

Eligibility criteria: Inclusion Criteria:

* 1. Age ≥18 years old and ≤90 years old
* 2. Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of Grade I or Grade II acute cholangitis
* 3. Imaging examination confirmed the presence of choledocholithiasis

Exclusion Criteria:

* 1. Common bile duct with benign or malignant stenosis
* 2. Changes in the anatomical structure of the stomach or duodenum
* 3. Patients with common biliary duct or pancreatic duct stent
* 4. Patients complicated with acute pancreatitis
* 5. Patients who underwent endoscopic intervention, percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions before admission
* 6. Patients with cardiac failure, respiratory failure or consciousness disorder can not tolerate endoscopic operation
* 7. Patients who have coagulation dysfunction or are taking anticoagulation and antiplate drugs
* 8. Imaging examination showed that the maximum diameter of choledocholithiasis was more than 1.5cm

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: