Cholecystectomy vs EUS-guided GBD With Stone Removal
- Conditions
- Cholelithiasis
- Interventions
- Procedure: Laparoscopic cholecystectomyProcedure: LAMS placement for cholecystostomy
- Registration Number
- NCT06038201
- Lead Sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elective laparoscopic cholecystectomy Laparoscopic cholecystectomy Patients \>18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration. EUS-GBD with stone clearance LAMS placement for cholecystostomy 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.
- Primary Outcome Measures
Name Time Method Technical success after surgical and endoscopic intervention Up to 6 hours Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.
Adverse events after the surgical procedures up to 14 days The post-surgical adverse events will be assessed by the Clavien-Dindo classification
Resolution of biliary symptoms up to 12 months Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.
Adverse events after the endoscopic procedures Up to 14 days The post-endoscopic adverse events will be assessed by the Adverse Events Gastrointestinal Endoscopy (AGREE) Classification
- Secondary Outcome Measures
Name Time Method Re-intervention rate 12-month follow-up Number of patients that requires a re-intervention after an endoscopic or surgical procedure
30-day major complications assessment up to 30 days To assess the safety of the procedures the investigators will consider the 30-day major complication rate
Trial Locations
- Locations (1)
Instituto Ecuatoriano de Enfermedades Digestivas
🇪🇨Guayaquil, Guayas, Ecuador