Cholecystectomy vs EUS-guided GBD With Stone Removal

Instituto Ecuatoriano de Enfermedades Digestivas

Status: Enrolling

Conditions: Cholelithiasis

Treatments: Procedure: LAMS placement for cholecystostomy; Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06038201

IECED-10022023

Details and patient eligibility

About

In this new era of less invasive procedures, the indications for endoscopic ultrasound (EUS)-guided gallbladder drainage (GBD) are rapidly expanding. Nowadays, the standard treatment for uncomplicated cholelithiasis (symptomatic patients not requiring hospital admission or non-surgically managed during one or more hospital admissions) is elective laparoscopic cholecystectomy.

To avoid the complications, difficulties and disadvantages of cholecystectomy, the investigators proposed a single-center study to determine the safety and effectiveness of EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston Scientific, Marlborough, MA, EEUU) with stone removal in patients with cholelithiasis, in comparison with the gold standard treatment, the elective laparoscopic cholecystectomy.

Full description

Currently, elective laparoscopic cholecystectomy (LC), is the preferred management for cholelithiasis in patients with history of gallstones-related adverse events, increased risk for gallbladder cancer, or recurrent typical biliary colic. Although elective LC is a commonly performed surgery, the incidence of serious adverse events is around 2.6%. Also, post-cholecystectomy syndrome, alkaline reflux gastritis and bile duct injury are chronic and feared adverse events secondary to gallbladder removal. To avoid them, a more conservative approach need to be address. The preservation of the gallbladder permits the conservation of its physiological functions, preventing LC adverse events, with potential less recovery time.

In this scenario, the endoscopic ultrasound (EUS) with lumen-apposing metal stent (LAMS)-assisted cholecystostomy for gallstones clearance has gained popularity due its trend toward an improved safety profile. The increased on advanced endoscopy experience along with the development of new stents, tools, and delivery systems, had placed the EUS-guided cholecystostomy as a plausible alternative to elective LC for acute cholecystitis, high-risk surgical patients, or patients with a concomitant bile duct neoplasia. In those contexts, EUS-guided cholecystostomy has demonstrated similar or even less hospitalization length of stays, adverse events, readmissions and reinterventions in comparison with elective LC or percutaneous drainage, respectively. Thus, the feasibility of EUS-guided cholecystostomy for cholelithiasis deserves to be explored.

This study pursues to compare between the effectiveness and safety of EUS-guided cholecystostomy and the elective laparoscopic cholecystectomy through an interventional, two group assignment, controlled trial.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults >18 years old and <89 years old
• Adult symptomatic patients with gallstones documented by US
• Subject is a suitable candidate for an elective laparoscopic cholecystectomy or an EUS-guided GBD
• Patients or authorized representative give informed consent for endoscopic or surgical approach

Exclusion criteria

• Patients with hepato-pancreato-biliary diseases other than gallstones (tumors, obstructions, inflammation)
• Patients with acute cholecystitis, cholangitis or choledocholithiasis.
• Patients with gallbladder polyps, family history of gallbladder cancer, or any other high-risk factor for gallbladder cancer
• Patient unable to give informed consent or refuse to participate.
• Prior biliary intervention
• Pregnancy or nursing
• Any other medical condition that contraindicates surgical or endoscopic procedures

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

EUS-GBD with stone clearance

Experimental group

Description:

Patients \>18-year-old with a diagnosis of gallstones by abdominal ultrasound, will be randomly allocated to EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston Scientific, Marlborough, MA, EEUU) with stone clearance.

Treatment:

Procedure: LAMS placement for cholecystostomy

Elective laparoscopic cholecystectomy

Active Comparator group

Description:

Patients \>18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration.

Treatment:

Procedure: Laparoscopic cholecystectomy