Wait-and-see strategy is justified after ERCP and endoscopic sphincterotomy in elderly patients with common biliary duct stones.
Antti Kivivuori, Laura Mattila, Antti Siiki...
https://pubmed.ncbi.nlm.nih.gov/36524923Actively Recruiting
Phase Not Applicable
Age: 75Years +
All Genders
ID07001423
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Led by Helsinki University Central Hospital · Updated on 2025-10-07
400
Participants Needed
12
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had common bile duct stones successfully removed using endoscopy. The study focuses on patients 75 years and older, including those with additional health issues, to determine if avoiding surgery is as safe as performing cholecystectomy. The main measurement is a combined outcome of death, serious complications, or recurring biliary problems within one year after randomization. Participants are randomly assigned to one of two groups: one will have laparoscopic cholecystectomy within two weeks following stone removal, and the other will be managed without surgery but can have cholecystectomy later if needed. The study includes an interim safety check after the first 100 participants, with a plan to stop early if significant differences arise. Both groups are monitored over time to assess health outcomes and complications. During the study, participants will be followed for at least one year to track outcomes such as survival, complications, biliary events, quality of life, pain, and healthcare costs. Assessments occur at various intervals, including 30, 180, and 365 days after randomization. Researchers will evaluate these factors carefully to understand the benefits and risks of each approach, ensuring participant safety throughout the trial.
CONDITIONS
Brief Title
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Who Can Participate
Age: 75Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Common bile duct stones cleared after Endoscopic Retrograde Cholangio Pancreatography (ERCP)
- Age 80 years or older, or age 75-79 years with a Charlson Comorbidity index of 2 or higher
- Gallbladder still in place
You will not qualify if you...
- Acute cholecystitis
- Biliary pancreatitis
- Severe or moderately severe post-ERCP pancreatitis
- Chronic pancreatitis
- Bile duct pathology
- Widespread malignancy
- Unable to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 weeks after randomization
Participants receive laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stones or are managed with a wait-and-see approach.
1 baseline visit and multiple follow-up visits up to 1 year
Follow-up
Duration - Up to 2 years
Participants are monitored for outcomes including complications, recurrent biliary events, and survival for up to 2 years after randomization.
Visits at 30 days, 180 days, 365 days, and additional assessments up to 2 years
Trial Site Locations
Total: 12 locations
1
Helsinki University Hospital, Jorvi
Espoo, Finland
Actively Recruiting
2
Kanta-Häme Central Hospital
Hämeenlinna, Finland
Not Yet Recruiting
3
Helsinki University Hospital, Meilahti
Helsinki, Finland
Actively Recruiting
4
Pohjois-Karjala Central Hospital
Joensuu, Finland
Not Yet Recruiting
5
Keski-Suomi Central Hospital
Jyväskylä, Finland
Not Yet Recruiting
6
Kymenlaakso Central Hospital
Kotka, Finland
Not Yet Recruiting
7
Kuopio University Hospital
Kuopio, Finland
Not Yet Recruiting
8
Päijät-Häme Central Hospital
Lahti, Finland
Not Yet Recruiting
9
Oulu University Hospital
Oulu, Finland
Not Yet Recruiting
10
Tampere University Hospital
Tampere, Finland
Not Yet Recruiting
11
Turku University Hospital
Turku, Finland
Not Yet Recruiting
12
Vaasa Central Hospital
Vaasa, Finland
Not Yet Recruiting
Loading map...
Research Team
P
Panu Mentula, MD, PhD
P
Päivi Siironen, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Routine laparoscopic cholecystectomy after endoscopic sphincterotomy for choledocholithiasis in octogenarians: is it worth the risk?
R Costi, D DiMauro, A Mazzeo...
https://pubmed.ncbi.nlm.nih.gov/17111279Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial.
Djemila Boerma, Erik A J Rauws, Yolande C A Keulemans...
https://pubmed.ncbi.nlm.nih.gov/12241833Patients over 65 years with Acute Complicated Calculous Biliary Disease are Treated Differently-Results and Insights from the ESTES Snapshot Audit.
Gary A Bass, Amy E Gillis, Yang Cao...
https://pubmed.ncbi.nlm.nih.gov/33813631