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Cholecystectomy vs EUS-guided GBD With Stone Removal

Primary Purpose

Cholelithiasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
LAMS placement for cholecystostomy
Laparoscopic cholecystectomy
Sponsored by
Instituto Ecuatoriano de Enfermedades Digestivas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring Cholelithiasis, biliary, cholecystostomy, laparoscopic, cholecystectomy, gallstones

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Ecuatoriano de Enfermedades Digestivas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EUS-GBD with stone clearance

Elective laparoscopic cholecystectomy

Arm Description

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.

Patients >18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration.

Outcomes

Primary Outcome Measures

Technical success after surgical and endoscopic intervention
Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.
Resolution of biliary symptoms
Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.
Adverse events after the surgical procedures
The post-surgical adverse events will be assessed by the Clavien-Dindo classification
Adverse events after the endoscopic procedures
The post-endoscopic adverse events will be assessed by the Adverse Events Gastrointestinal Endoscopy (AGREE) Classification

Secondary Outcome Measures

30-day major complications assessment
To assess the safety of the procedures the investigators will consider the 30-day major complication rate
Re-intervention rate
Number of patients that requires a re-intervention after an endoscopic or surgical procedure

Full Information

First Posted
August 30, 2023
Last Updated
September 7, 2023
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
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1. Study Identification

Unique Protocol Identification Number
NCT06038201
Brief Title
Cholecystectomy vs EUS-guided GBD With Stone Removal
Official Title
Cholelithiasis Management: Elective Laparoscopic Cholecystectomy vs EUS-guided Gallbladder Cholecystostomy for Gallstones Clearance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
October 2, 2024 (Anticipated)
Study Completion Date
November 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
Cholelithiasis, biliary, cholecystostomy, laparoscopic, cholecystectomy, gallstones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A controlled, non-inferiority prospective trial
Masking
Investigator
Allocation
Non-Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS-GBD with stone clearance
Arm Type
Experimental
Arm Description
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.
Arm Title
Elective laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
Patients >18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration.
Intervention Type
Procedure
Intervention Name(s)
LAMS placement for cholecystostomy
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical success after surgical and endoscopic intervention
Description
Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.
Time Frame
Up to 6 hours
Title
Resolution of biliary symptoms
Description
Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.
Time Frame
up to 12 months
Title
Adverse events after the surgical procedures
Description
The post-surgical adverse events will be assessed by the Clavien-Dindo classification
Time Frame
up to 14 days
Title
Adverse events after the endoscopic procedures
Description
The post-endoscopic adverse events will be assessed by the Adverse Events Gastrointestinal Endoscopy (AGREE) Classification
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
30-day major complications assessment
Description
To assess the safety of the procedures the investigators will consider the 30-day major complication rate
Time Frame
up to 30 days
Title
Re-intervention rate
Description
Number of patients that requires a re-intervention after an endoscopic or surgical procedure
Time Frame
12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Robles-Medranda, MD, FASGE
Phone
+59342109180
Email
carlosoakm@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, MD, FASGE
Organizational Affiliation
Instituto Ecuatoriano de Enfermedades Digestivas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Ecuatoriano de Enfermedades Digestivas
City
Guayaquil
State/Province
Guayas
ZIP/Postal Code
090505
Country
Ecuador

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32661706
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.
Results Reference
background
PubMed Identifier
37398926
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.
Results Reference
background
PubMed Identifier
28028405
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.
Results Reference
background
PubMed Identifier
32117490
Citation
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.
Results Reference
background
PubMed Identifier
34677160
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.
Results Reference
background

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Cholecystectomy vs EUS-guided GBD With Stone Removal

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