ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
Healthy Volunteers: f
View:
• Common bile duct stones cleared after Endoscopic Retrograde Cholangio Pancreatography (ERCP)
• Age \>= 80 years or age 75-79 years with a Charlson Comorbidity index \>=2
• gallbladder in situ
Locations
Other Locations
Finland
Helsinki University Hospital, Jorvi
RECRUITING
Espoo
Kanta-Häme Central Hospital
NOT_YET_RECRUITING
Hämeenlinna
Helsinki University Hospital, Meilahti
RECRUITING
Helsinki
Pohjois-Karjala Central Hospital
NOT_YET_RECRUITING
Joensuu
Keski-Suomi Central Hospital
NOT_YET_RECRUITING
Jyväskylä
Kymenlaakso Central Hospital
NOT_YET_RECRUITING
Kotka
Kuopio University Hospital
NOT_YET_RECRUITING
Kuopio
Päijät-Häme Central Hospital
NOT_YET_RECRUITING
Lahti
Oulu University Hospital
NOT_YET_RECRUITING
Oulu
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Turku University Hospital
NOT_YET_RECRUITING
Turku
Vaasa Central Hospital
NOT_YET_RECRUITING
Vaasa
Contact Information
Primary
Panu Mentula, MD, PhD
panu.mentula@hus.fi
+358504270183
Backup
Päivi Siironen, MD, PhD
paivi.siironen@hus.fi
+358504271343
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2032-08-31
Participants
Target number of participants: 400
Treatments
Active_comparator: Cholecystectomy
Laparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones.
No_intervention: Wait-and-see
After endoscopic removal of common bile duct stones, patients are managed non-operatively. During the follow-up cholecystectomy will be available on demand.
Related Therapeutic Areas
Sponsors
Leads: Helsinki University Central Hospital