Efficacy and Safety of Single-session Endoscopic Stone Extraction
1 other identifier
observational
563
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedJuly 17, 2024
March 1, 2024
4 months
March 11, 2024
July 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Success rate of complete stone removal
Segmental angiography was performed by balloon closure to determine the presence or absence of negative stone shadow
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.
from the operation to 1 month after the operation
Secondary Outcomes (2)
Length of stay
perioperatively
Hospital expenses
perioperatively
Study Arms (2)
two-session treatment group
two-session ERCP
single-session treatment group
single-session ERCP
Interventions
early endoscopic drainage followed by endoscopic stone extraction
Eligibility Criteria
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.
You may qualify if:
- Age ≥18 years old
- Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of acute cholangitis
- Imaging examination confirmed the presence of choledocholithiasis
- Patients received endoscopic single-session stone extraction or two-session treatment involving stone removal after drainage
You may not qualify if:
- Common bile duct with benign or malignant stenosis
- Changes in the anatomical structure of the stomach or duodenum
- Patients complicated with severe acute pancreatitis
- Patients who underwent endoscopic intervention before admission
- Patients received percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions besides endoscopic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fujing Lv, M.D.
Beijing Friendship Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2024
First Posted
March 25, 2024
Study Start
January 1, 2024
Primary Completion
May 1, 2024
Study Completion
July 1, 2024
Last Updated
July 17, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share