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Clinical Trials/NCT06038201
NCT06038201UnknownNot Applicable

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

Instituto Ecuatoriano de Enfermedades Digestivas2 sites in 1 country56 target enrollmentStarted: October 25, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
56
Locations
2
Primary Endpoint
Technical success after surgical and endoscopic intervention

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Technical success after surgical and endoscopic intervention

Time Frame: 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

Time Frame: up to 14 days

The post-surgical adverse events will be assessed by the Clavien-Dindo classification

Resolution of biliary symptoms

Time Frame: 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

Time Frame: Up to 14 days

The post-endoscopic adverse events will be assessed by the Adverse Events Gastrointestinal Endoscopy (AGREE) Classification

Secondary Outcomes

  • Re-intervention rate(12-month follow-up)
  • 30-day major complications assessment(up to 30 days)

Investigators

Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carlos Robles-Medranda

Head of Endoscopy Division

Instituto Ecuatoriano de Enfermedades Digestivas

Study Sites (2)

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