Cholecystectomy, LaparoscopicCOFFEENCT07001423
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
A study testing Laparoscopic cholecystectomy in people with Cholecystectomy, Laparoscopic and Choledocholithiasis, run by Helsinki University Central Hospital at 12 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Choledocholithiasis, Cholelithiasis
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 12 sitesFinland
- Study dates
- 9 Oct 2025to 31 Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Acute Cholecystitis
- Biliary Pancreatitis
- Severe or moderately severe post-ERCP pancreatitis
- Chronic pancreatitis
- Bile duct pathology
- Widespread malignancy
- Unable to give consent
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Finland12 sites, 12 recruiting
- Recruiting
Helsinki University Hospital, Jorvi
Espoo
Hanna Malmi, MD, PhD, +358505123553, hanna.malmi@hus.fi
- Not yet recruiting
Kanta-Häme Central Hospital
Hämeenlinna
- Recruiting
Helsinki University Hospital, Meilahti
Helsinki
Päivi Siironen, MD, PhD, +358504271343, paivi.siironen@hus.fi
- Not yet recruiting
Pohjois-Karjala Central Hospital
Joensuu
- Not yet recruiting
Keski-Suomi Central Hospital
Jyväskylä
- Not yet recruiting
Kymenlaakso Central Hospital
Kotka
- Not yet recruiting
Kuopio University Hospital
Kuopio
- Not yet recruiting
Päijät-Häme Central Hospital
Lahti
- Not yet recruiting
Oulu University Hospital
Oulu
- Not yet recruiting
Tampere University Hospital
Tampere
- Not yet recruiting
Turku University Hospital
Turku
- Not yet recruiting
Vaasa Central Hospital
Vaasa
About this study
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.
Read the detailed description
Elderly patients with common bile duct stones are asked to participate this randomized trial after successful endoscopic removal of common bile duct stones. The hypothesis of the study is that wait-and-see policy is non-inferior to laparoscopic cholecystectomy. Four hundred patients are randomized 1:1 to either laparoscopic cholecystectomy group or wait-and see group. Cholecystectomy is done on the same admission or within two weeks after randomization. One interim analysis is planned for the trial after 100 randomized patients to assess safety. The trial is terminated if there is a statistically significant difference in primary outcome with p<0.001 (chi-square test) between the study arms.
- Being tested
- Laparoscopic cholecystectomy
- Medical subject headings
- Choledocholithiasis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone
| Study group | Role | What they receive |
|---|---|---|
| Cholecystectomy | Active comparator | Laparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones. Receives: Procedure: Laparoscopic cholecystectomy |
| Wait-and-see | No intervention | After endoscopic removal of common bile duct stones, patients are managed non-operatively. During the follow-up cholecystectomy will be available on demand. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From randomization to 1 year
Secondary outcomes (8)
Number of good days
Number of days alive and out of hospital
Measured: From randomization to 1 year
EQ VAS value
Quality of life is measured using EuroQOL EQ-5D-5L instrument, EQ VAS values are compared. 0 represents the worst health a person can imagine and 100 represents the the best health a person can imagine. EQ-5D-5L dimension responses are reported as a descriptive data
Measured: at 30 days, 180 days and 365 days after randomization
Survival
Survival is measured using Kaplan-Meier analysis
Measured: From randomization to 1 year
Number of patients with major complications
Number of patients with major complications defined as infectious, cardiovascular, and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher)
Measured: From randomization to 1 year
Number of patients with recurrent biliary event
Number of patients with recurrent biliary event (cholecystitis, pancreatitis, cholangitis, or symptomatic bile duct stones)
Measured: From randomization to 1 year
Composite outcome of death or occurrence of major complications or recurrent biliary event requiring hospitalization
The same as primary outcome, but after 2 years follow-up
Measured: From randomization to 2 years
Number of patients with uncomplicated biliary pain or post cholecystectomy pain
Uncomplicated biliary pain/ post cholecystectomy pain. Specific 5 criteria of biliary pain include : 1. severe pain attacks, 2. lasting 15 to 30 minutes or longer, 3. location in epigastrium or right upper quadrant, 4. pain radiating to the back, 5. a positive pain response to simple analgesics
Measured: At 30, 180 and 365 days after randomization
Healthcare costs
Healthcare costs related to bile stones; including laboratory tests, imaging (ultra sound, computer tomography, magnetic resonance imaging), procedures (Endoscopic Retrograde Cholangio Pancreatography (ERCP), laparoscopic cholecystectomy), emergency visits and hospital days.
Measured: From randomization to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start9 Oct 2025
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panu Mentula, Helsinki University Central Hospital
- Investigators
- Panu Mentula, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001423
- Sponsor's protocol ID
- 8971
- Acronym
- COFFEE
- Status last verified
- Oct 2025
- First submitted
- 23 May 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36524923Costi 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.
PubMed 17111279Boerma 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.
PubMed 12241833Bass 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.
PubMed 33813631
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
- ClinicalTrials.gov ID
- NCT07001423
- Acronym / sponsor ID
- COFFEE / 8971
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Elderly patients with common bile duct stones are asked to participate this randomized trial after successful endoscopic removal of common bile duct stones. The hypothesis of the study is that wait-and-see policy is non-inferior to laparoscopic cholecystectomy. Four hundred patients are randomized 1:1 to either laparoscopic cholecystectomy group or wait-and see group. Cholecystectomy is done on the same admission or within two weeks after randomization. One interim analysis is planned for the trial after 100 randomized patients to assess safety. The trial is terminated if there is a statistically significant difference in primary outcome with p<0.001 (chi-square test) between the study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomyLaparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones. |
| Wait-and-see | No intervention | –After endoscopic removal of common bile duct stones, patients are managed non-operatively. During the follow-up cholecystectomy will be available on demand. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Acute Cholecystitis
- Biliary Pancreatitis
- Severe or moderately severe post-ERCP pancreatitis
- Chronic pancreatitis
- Bile duct pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone | Procedure or surgery | Cholecystectomy |
Primary outcome
Number of participants with composite outcome of death, major complication or recurrent biliary event
Time frame: From randomization to 1 year
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)
8 secondary outcomes
Number of good days
Time frame: From randomization to 1 year
EQ VAS value
Time frame: at 30 days, 180 days and 365 days after randomization
Survival
Time frame: From randomization to 1 year
Number of patients with major complications
Time frame: From randomization to 1 year
Number of patients with recurrent biliary event
Time frame: From randomization to 1 year
Composite outcome of death or occurrence of major complications or recurrent biliary event requiring hospitalization
Time frame: From randomization to 2 years
Number of patients with uncomplicated biliary pain or post cholecystectomy pain
Time frame: At 30, 180 and 365 days after randomization
Healthcare costs
Time frame: From randomization to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 36524923Kivivuori 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.
- Background: PubMed 17111279Costi 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.
- Background: PubMed 12241833Boerma 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.
- Background: PubMed 33813631Bass 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Panu Mentula, MD, PhD principal investigator
Helsinki University Central Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy in people with Cholecystectomy, Laparoscopic and Choledocholithiasis, run by Helsinki University Central Hospital at 12 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panu Mentula, MD, PhD (+358504270183, panu.mentula@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with composite outcome of death, major complication or recurrent biliary event (time frame: From randomization to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001423, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.