Actively Recruiting
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
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to compare safety and efficacy of laparoscopic cholecystectomy versus wait-and-see policy after endoscopic removal of common bile duct stones in elderly. The primary endpoint is a composite outcome: Death or major postoperative complications or recurrent biliary disease within 1 year after randomization.
CONDITIONS
Official Title
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Who Can Participate
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 present (in situ)
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
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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
Research Team
P
Panu Mentula, MD, PhD
CONTACT
P
Päivi Siironen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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