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Cholecystectomy vs EUS-guided GBD With Stone Removal

NCT06038201 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-03-29

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

LAMS placement for cholecystostomy

The EUS-guided cholecystostomy entails placing a 10 mm x 10 mm or 10mm x 15mm Electrocautery-Enhanced LAMS for direct cholecystoscopy with a transnasal gastroscope. Then, the cholecystostomy will be performed with an echoendoscope, assisted by fluoroscopy to allow the puncturing of the gallbladder form either the duodenal bulb (cholecysto-duodenoscopy) or the gastric antrum (cholecysto-gastrostomy). Subsequently, from the most optimal anatomic point it will be tutored with a 10mmx10mm or 10mm x 15mm LAMS to create anastomosis between the structures. Then, the stone clearance will be performed by endoscopy (basket catheters) or by cholangioscopy (mechanical lithotripsy with or without basket catheters).

PROCEDURE

Laparoscopic cholecystectomy

A laparoscopic biliary exploration along with an elective laparoscopic cholecystectomy will be performed by experienced laparoscopic surgeons (over 100 laparoscopic procedures yearly) by three or four-trocar technique with transection of the cystic duct and artery.

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos Robles-Medranda, MD, FASGE · Instituto Ecuatoriano de Enfermedades Digestivas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2024-10-02
Completion
2024-11-02

Countries

  • Ecuador

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06038201 on ClinicalTrials.gov