Clinical trial NCT07001423: ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Official title: ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Choledocholithiasis
Cholelithiasis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 400
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Acute Cholecystitis
* Biliary Pancreatitis
* Severe or moderately severe post-ERCP pancreatitis
* Chronic pancreatitis
* Bile duct pathology
* Widespread malignancy
* Unable to give consent

Primary outcomes:
measure: Number of participants with composite outcome of death, major complication or recurrent biliary event
timeFrame: From randomization to 1 year
Secondary outcomes:
measure: Number of good days
timeFrame: From randomization to 1 year
measure: EQ VAS value
timeFrame: at 30 days, 180 days and 365 days after randomization
measure: Survival
timeFrame: From randomization to 1 year
measure: Number of patients with major complications
timeFrame: From randomization to 1 year
measure: Number of patients with recurrent biliary event
timeFrame: From randomization to 1 year
measure: Composite outcome of death or occurrence of major complications or recurrent biliary event requiring hospitalization
timeFrame: From randomization to 2 years
measure: Number of patients with uncomplicated biliary pain or post cholecystectomy pain
timeFrame: At 30, 180 and 365 days after randomization
measure: Healthcare costs
timeFrame: From randomization to 1 year
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Hospital, Jorvi
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Meilahti
city: Hämeenlinna
country: Finland
facility: Kanta-Häme Central Hospital
city: Joensuu
country: Finland
facility: Pohjois-Karjala Central Hospital
city: Jyväskylä
country: Finland
facility: Keski-Suomi Central Hospital
city: Kotka
country: Finland
facility: Kymenlaakso Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Panu Mentula, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Costi 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.
citation: Boerma 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.
citation: Bass 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.