ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

Not Applicable

Not yet recruiting

• Conditions: Cholecystectomy, Laparoscopic; Choledocholithiasis; Cholelithiasis

• Registration Number: NCT07001423
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Status Verified: 2025-06
• Study First Posted: 2025-06-03
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10
• Study Start: 2025-09-01
• Primary Completion: 2031-08-31
• Study Completion: 2032-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with composite outcome of death, major complication or recurrent biliary event	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)

Secondary Outcome Measures

Name	Time	Method
Number of patients with recurrent biliary event	From randomization to 1 year	Number of patients with recurrent biliary event (cholecystitis, pancreatitis, cholangitis, or symptomatic bile duct stones)
Number of patients with uncomplicated biliary pain or post cholecystectomy pain	At 30, 180 and 365 days after randomization	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
Healthcare costs	From randomization to 1 year	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.
Number of good days	From randomization to 1 year	Number of days alive and out of hospital
EQ VAS value	at 30 days, 180 days and 365 days after randomization	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
Survival	From randomization to 1 year	Survival is measured using Kaplan-Meier analysis
Number of patients with major complications	From randomization to 1 year	Number of patients with major complications defined as infectious, cardiovascular, and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher)
Composite outcome of death or occurrence of major complications or recurrent biliary event requiring hospitalization	From randomization to 2 years	The same as primary outcome, but after 2 years follow-up

Trial Locations

Locations (12)

Helsinki University Hospital, Jorvi; 🇫🇮 Espoo, Finland

Helsinki University Hospital, Meilahti; 🇫🇮 Helsinki, Finland

Kanta-Häme Central Hospital; 🇫🇮 Hämeenlinna, 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

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