CompletedNot Applicable

Effectiveness and Safety of Single-session Endoscopic Stone Extraction

China64 participantsStarted 2024-04-15

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Success rate of complete stone removal

Timeframe: during the operation

ERCP-related complication rate

Timeframe: from the operation to 1 month after the operation

Trial details

NCT IDNCT06349954

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Choledocholithiasis With Acute Cholangitis trials