ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
COFFEE
1 other identifier
interventional
400
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 3, 2025
CompletedStudy Start
First participant enrolled
October 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2032
October 7, 2025
October 1, 2025
5.9 years
May 23, 2025
October 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with composite outcome of death, major complication or recurrent biliary event
The primary outcome is a composite outcome including death within 1 year after randomization, the occurrence of major complications within 30 days from surgery and recurrent biliary event requiring hospitalization. within 1 year after randomization. A recurrent biliary event refers to cholecystitis, pancreatitis, cholangitis, or bile duct stones. Major complications were defined as infectious, cardiovascular and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher)
From randomization to 1 year
Secondary Outcomes (8)
Number of good days
From randomization to 1 year
EQ VAS value
at 30 days, 180 days and 365 days after randomization
Survival
From randomization to 1 year
Number of patients with major complications
From randomization to 1 year
Number of patients with recurrent biliary event
From randomization to 1 year
- +3 more secondary outcomes
Study Arms (2)
Cholecystectomy
ACTIVE COMPARATORLaparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones.
Wait-and-see
NO INTERVENTIONAfter endoscopic removal of common bile duct stones, patients are managed non-operatively. During the follow-up cholecystectomy will be available on demand.
Interventions
Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Acute Cholecystitis
- Biliary Pancreatitis
- Severe or moderately severe post-ERCP pancreatitis
- Chronic pancreatitis
- Bile duct pathology
- Widespread malignancy
- Unable to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Helsinki University Hospital, Jorvi
Espoo, Finland
Kanta-Häme Central Hospital
Hämeenlinna, Finland
Helsinki University Hospital, Meilahti
Helsinki, Finland
Pohjois-Karjala Central Hospital
Joensuu, Finland
Keski-Suomi Central Hospital
Jyväskylä, Finland
Kymenlaakso Central Hospital
Kotka, Finland
Kuopio University Hospital
Kuopio, Finland
Päijät-Häme Central Hospital
Lahti, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Vaasa Central Hospital
Vaasa, Finland
Related Publications (4)
Kivivuori A, Mattila L, Siiki A, Laukkarinen J, Rantanen T, Ukkonen M. Wait-and-see strategy is justified after ERCP and endoscopic sphincterotomy in elderly patients with common biliary duct stones. J Trauma Acute Care Surg. 2023 Mar 1;94(3):443-447. doi: 10.1097/TA.0000000000003852. Epub 2022 Dec 14.
PMID: 36524923BACKGROUNDCosti R, DiMauro D, Mazzeo A, Boselli AS, Contini S, Violi V, Roncoroni L, Sarli L. Routine laparoscopic cholecystectomy after endoscopic sphincterotomy for choledocholithiasis in octogenarians: is it worth the risk? Surg Endosc. 2007 Jan;21(1):41-7. doi: 10.1007/s00464-006-0169-2. Epub 2006 Nov 16.
PMID: 17111279BACKGROUNDBoerma D, Rauws EA, Keulemans YC, Janssen IM, Bolwerk CJ, Timmer R, Boerma EJ, Obertop H, Huibregtse K, Gouma DJ. Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial. Lancet. 2002 Sep 7;360(9335):761-5. doi: 10.1016/S0140-6736(02)09896-3.
PMID: 12241833BACKGROUNDBass GA, Gillis AE, Cao Y, Mohseni S; European Society for Trauma and Emergency Surgery (ESTES) Cohort Studies Group. Patients over 65 years with Acute Complicated Calculous Biliary Disease are Treated Differently-Results and Insights from the ESTES Snapshot Audit. World J Surg. 2021 Jul;45(7):2046-2055. doi: 10.1007/s00268-021-06052-0. Epub 2021 Apr 3.
PMID: 33813631BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Panu Mentula, MD, PhD
Helsinki University Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Head of Emergency Surgery
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 3, 2025
Study Start
October 3, 2025
Primary Completion (Estimated)
August 31, 2031
Study Completion (Estimated)
August 31, 2032
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share