ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-03

Study Completion Date

2032-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Common Bile Duct Stone Management: What Have we Learned?

NCT02155244

Common Bile Duct Stones

COMPLETED

Elective Endoscopic Gallbladder Treatment: Pilot Study

NCT05723224

Cholecystolithiasis Cholecystitis, Chronic

UNKNOWN NA

Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis

NCT05141916

Biliary Disease Choledocholithiasis

RECRUITING

Early Versus Late Laparoscopic Exploration of Common Bile Duct After Failure of Extraction of Common Bile Duct Stones by ERCP

NCT05823181

Common Bile Duct Calculi

NOT_YET_RECRUITING

Effectiveness and Safety of Single-session Endoscopic Stone Extraction

NCT06349954

Choledocholithiasis With Acute Cholangitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholecystectomy, Laparoscopic Choledocholithiasis Cholelithiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cholecystectomy

Laparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones.

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Panu Mentula

MD, PhD, Head of Emergency Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Panu Mentula, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Helsinki University Hospital, Jorvi

Espoo, , Finland

Site Status RECRUITING