Cholelithiasis Management: Elective Laparoscopic Cholecystectomy vs EUS-guided Gallbladder Cholecystostomy for Gallstones Clearance

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ecuador
Instituto Ecuatoriano de Enfermedades Digestivas
RECRUITING
Guayaquil
Contact Information
Primary
Carlos Robles-Medranda, MD, FASGE
carlosoakm@yahoo.es
+59342109180
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2024-11-02
Participants
Target number of participants: 56
Treatments
Experimental: EUS-GBD with stone clearance
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.
Active_comparator: Elective 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.
Sponsors
Leads: Instituto Ecuatoriano de Enfermedades Digestivas

This content was sourced from clinicaltrials.gov

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