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Cholecystectomy vs EUS-guided GBD With Stone Removal

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ClinicalTrials.gov Identifier: NCT06038201
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : March 29, 2024
Sponsor:
Information provided by (Responsible Party):
Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cholelithiasis Procedure: LAMS placement for cholecystostomy Procedure: Laparoscopic cholecystectomy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A controlled, non-inferiority prospective trial
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Cholelithiasis Management: Elective Laparoscopic Cholecystectomy vs EUS-guided Gallbladder Cholecystostomy for Gallstones Clearance
Actual Study Start Date : October 25, 2023
Estimated Primary Completion Date : October 2, 2024
Estimated Study Completion Date : November 2, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Arms and Interventions
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Arm Intervention/treatment
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.
 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).
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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 Outcome Measures :
  1. 30-day major complications assessment [ Time Frame: up to 30 days ]
    To assess the safety of the procedures the investigators will consider the 30-day major complication rate

  2. Re-intervention rate [ Time Frame: 12-month follow-up ]
    Number of patients that requires a re-intervention after an endoscopic or surgical procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06038201


Contacts
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Contact: Carlos Robles-Medranda, MD, FASGE +59342109180 carlosoakm@yahoo.es

Locations
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Ecuador
Instituto Ecuatoriano de Enfermedades Digestivas Recruiting
Guayaquil, Guayas, Ecuador, 090505
Contact: Carlos Robles-Medranda, MD, FASGE    +59342109180    carlosoakm@yahoo.es   
Principal Investigator: Carlos Robles-Medranda, MD         
Sub-Investigator: Hannah Pitanga-Lukashok, MD         
Sub-Investigator: Juan Alcivar-Vasquez, MD         
Sub-Investigator: Maria Egas-Izquierdo, MD         
Sub-Investigator: Miguel Puga-Tejada, MD         
Sub-Investigator: Jorge Baquerizo-Burgos, MD         
Sub-Investigator: Domenica Cunto, MD         
Sub-Investigator: Martha Arevalo-Mora, MD         
Sub-Investigator: Raquel Del Valle, MD         
Sub-Investigator: Daniel Calle-Loffredo, MD         
Sponsors and Collaborators
Instituto Ecuatoriano de Enfermedades Digestivas
Investigators
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Principal Investigator: Carlos Robles-Medranda, MD, FASGE Instituto Ecuatoriano de Enfermedades Digestivas
More Information
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Publications:

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Responsible Party: Carlos Robles-Medranda, Head of Endoscopy Division, Instituto Ecuatoriano de Enfermedades Digestivas
ClinicalTrials.gov Identifier: NCT06038201    
Other Study ID Numbers: IECED-10022023
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas:
Cholelithiasis
biliary
cholecystostomy
 laparoscopic
cholecystectomy
gallstones
Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
 Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical