Cholecystectomy vs EUS-guided GBD With Stone Removal

NCT06038201 | Recruiting

• 1 other identifier: IECED-10022023
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiasis

Keywords

Cholelithiasis; biliary; cholecystostomy; laparoscopic; cholecystectomy; gallstones

Outcome Measures

Primary Outcomes (4)

• Technical success after surgical and endoscopic intervention

  Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.

  Up to 6 hours

• Resolution of biliary symptoms

  Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.

  up to 12 months

• Adverse events after the surgical procedures

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

  up to 14 days

• Adverse events after the endoscopic procedures

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

  Up to 14 days

Secondary Outcomes (2)

• 30-day major complications assessment

  up to 30 days

• Re-intervention rate

  12-month follow-up

Study Arms (2)

EUS-GBD with stone clearance

EXPERIMENTAL

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

Elective laparoscopic cholecystectomy

ACTIVE COMPARATOR

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

Interventions

LAMS placement for cholecystostomy PROCEDURE

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).

EUS-GBD with stone clearance

Laparoscopic cholecystectomy PROCEDURE

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.

Elective laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas

Guayaquil, Guayas, 090505, Ecuador

RECRUITING

Related Publications (5)

• Kamarajah SK, Karri S, Bundred JR, Evans RPT, Lin A, Kew T, Ekeozor C, Powell SL, Singh P, Griffiths EA. Perioperative outcomes after laparoscopic cholecystectomy in elderly patients: a systematic review and meta-analysis. Surg Endosc. 2020 Nov;34(11):4727-4740. doi: 10.1007/s00464-020-07805-z. Epub 2020 Jul 13.

  PMID: 32661706 BACKGROUND

• Radlinski MJ, Strand DS, Shami VM. Evolution of interventional endoscopic ultrasound. Gastroenterol Rep (Oxf). 2023 Jun 30;11:goad038. doi: 10.1093/gastro/goad038. eCollection 2023.

  PMID: 37398926 BACKGROUND

• Radunovic M, Lazovic R, Popovic N, Magdelinic M, Bulajic M, Radunovic L, Vukovic M, Radunovic M. Complications of Laparoscopic Cholecystectomy: Our Experience from a Retrospective Analysis. Open Access Maced J Med Sci. 2016 Dec 15;4(4):641-646. doi: 10.3889/oamjms.2016.128. Epub 2016 Nov 9.

  PMID: 28028405 BACKGROUND

• Du QC, Wang YY, Hu CL, Zhou Y. Reconsideration of indications for choledochoscopic gallbladder-preserving surgery and preventive measures for postoperative recurrence of gallstones. Wideochir Inne Tech Maloinwazyjne. 2020 Mar;15(1):87-96. doi: 10.5114/wiitm.2019.88647. Epub 2019 Oct 17.

  PMID: 32117490 BACKGROUND

• Flynn DJ, Memel Z, Hernandez-Barco Y, Visrodia KH, Casey BW, Krishnan K. Outcomes of EUS-guided transluminal gallbladder drainage in patients without cholecystitis. Endosc Ultrasound. 2021 Sep-Oct;10(5):381-386. doi: 10.4103/EUS-D-21-00040.

  PMID: 34677160 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Gallstones

Interventions

Cholecystostomy; Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Cholecystectomy; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Carlos Robles-Medranda, MD, FASGE

  Instituto Ecuatoriano de Enfermedades Digestivas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Robles-Medranda, MD, FASGE

CONTACT

+59342109180; carlosoakm@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopy Division

Model Details: A controlled, non-inferiority prospective trial

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 14, 2023
• Study Start: October 25, 2023
• Primary Completion: October 2, 2024
• Study Completion: November 2, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)