Cholecystectomy vs EUS-guided GBD With Stone Removal

Cholelithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038201
• Other study ID #: IECED-10022023
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: November 2, 2024

Study information

• Verified date: March 2024
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: Carlos Robles-Medranda, MD, FASGE
• Phone: +59342109180
• Email: carlosoakm[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: November 2, 2024
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

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).
• 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.

Locations

Country	Name	City	State
Ecuador	Instituto Ecuatoriano de Enfermedades Digestivas	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Resolution of biliary symptoms	Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.	up to 12 months
Primary	Adverse events after the surgical procedures	The post-surgical adverse events will be assessed by the Clavien-Dindo classification	up to 14 days
Primary	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	30-day major complications assessment	To assess the safety of the procedures the investigators will consider the 30-day major complication rate	up to 30 days
Secondary	Re-intervention rate	Number of patients that requires a re-intervention after an endoscopic or surgical procedure	12-month follow-up