An interventional study of single-session ERCP and two-session ERCP in Choledocholithiasis With Acute Cholangitis, sponsored by Beijing Friendship Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 64 is below the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Beijing Friendship Hospital is the lead sponsor of 217 studies on the registry; 94 are open to participants now.
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Exclusion Criteria:
single-session ERCP
Procedure: single-session ERCP
two-session ERCP
Procedure: two-session ERCP
directly endoscopic stone extraction
early endoscopic drainage followed by endoscopic stone extraction
Success rate of complete stone removal
Segmental angiography was performed by balloon closure to determine the presence or absence of negative stone shadow
Time frame: during the operation
ERCP-related complication rate
The 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.
Time frame: from the operation to 1 month after the operation
Length of stay
Total time from admission to discharge.
Time frame: perioperatively
Hospital expenses
Total expenses from admission to discharge.
Time frame: perioperatively
Ran from Apr 2024 to primary completion in Dec 2024, 8 months.
Of 41 non-industry interventional studies with no phase under Choledocholithiasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 8 months is below that.
Counting every sponsor, half of 43 studies reached it within 21 months; a quarter within 12 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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