An observational study in Choledocholithiasis With Acute Cholangitis, sponsored by Beijing Friendship Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Beijing Friendship Hospital · Observational
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.
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.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 563 is above the median of 200 across 31 observational studies indexed under Choledocholithiasis.
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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.
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Exclusion Criteria:
two-session ERCP
Procedure: two-session ERCP
single-session ERCP
Procedure: single-session ERCP
early endoscopic drainage followed by endoscopic stone extraction
directly 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
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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