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Elective Endoscopic Gallbladder Treatment: Pilot Study (SLATAN)

Primary Purpose

Cholecystolithiasis, Cholecystitis, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
elective endoscopic gallbladder treatment
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystolithiasis focused on measuring Eus guided gallbladder drainage

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Age ≥75 years Benign gallbladder diseases with an indication to perform cholecystectomy high surgical risk (ASA score ≥3) Signed written informed consent Exclusion criteria Patients unwilling to undergo follow-up assessments Age <75 years Low surgical risk (ASA score <3) Patients with suspected gangrene or perforation of the gallbladder Ongoing acute cholecystitis Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and/or duodenum Abnormal coagulation (INR > 1.5 and/or platelets < 50.000/mm3) Contraindication to perform endoscopy Inability to give informed consent

Sites / Locations

  • Fondazione Policlinico Universitario Agostino GemelliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic ultrasound-guided gallbladder treatment

Arm Description

Endoscoipc gallbladder drainage under EUS guide using lumen apposing metal stents (LAMS) followed when needed by endoscopic lithotripsy.

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs) after EUS-guided gallbladder treatment
AEs will be classified as procedural when they occur during the procedure; post-procedural when they will occur up to 14 days after the procedure; late when they will occur more than 14 days after the procedure. Minor AEs will be those that need no therapy and have no sequelae (A) or have minor therapy or consequence, including overnight admission (B). Major events include those that require major therapy or hospitalization (24- 48 hours) (C); major therapy, need unplanned increase in level of care, or hospitalization >48 hours (D); or result in permanent adverse sequelae (E) and death (F).

Secondary Outcome Measures

Rate of Technical success
Number of patients achieving successful placement of the LAMS stent between the gastric/duodenal cavity and the gallbladder

Full Information

First Posted
February 1, 2023
Last Updated
February 1, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05723224
Brief Title
Elective Endoscopic Gallbladder Treatment: Pilot Study
Acronym
SLATAN
Official Title
Elective Endoscopic Gallbladder Treatment in Elderly Patients With Benign Gallbladder Diseases at High Surgical Risk: a Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
June 14, 2023 (Anticipated)
Study Completion Date
December 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

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

5. Study Description

Brief Summary
Laparoscopic cholecystectomy (LC) represents the gold standard for treatment of elective and acute of gallbladder diseases, such as acute cholecystitis (AC). However, in elderly patients or in those with severe comorbidities, urgent LC can be associated with increase morbidity (up to 41%) and mortality (up to 19%). In these patients, placement of a percutaneous gallbladder drainage catheter (PT-GBD) or colecistostomy can be utilized to drain the gallbladder until infection is resolved, as a bridge to subsequent surgery or as definitive treatment. PT-GBD, however, is associated with major adverse events (AEs): intra-hepatic hemorrhage, pneumothorax, biliary peritonitis, bile leak from the site of drainage, AC recurrency, self-removal of the drainage by the patient e/o for spontaneous migration. Recently, to overcome PT-GBD limitations, EUS-guided gallbladder drainage (EUS-GBD) has been introduced as an alternative minimally invasive therapeutic intervention for treatment of patients with high surgical risk who present with AC. The procedure has high technical and clinical success rates and favorable safety profile, with low risk of recurrent AC. EUS-GBD, followed, when needed, by intra-cholecystic endoscopic interventions has been utilized even in relatively young patients as recently reported with successful intra-cholecystic giant stones clearance through the LAMS using previously described endoscopic lithotripsy in patients who rejected surgery and desired gallbladder preservation. A second category of patients who might benefit from EEGBT are elderly individuals with major comorbidities posing them at high surgical risk, who suffer from previous episodes of cholecystitis, recurrent colic episodes due to gallbladder stones, or with biliary acute pancreatitis due to stones migration. Based on all the above considerations, we have designed a prospective, pilot study to evaluate the safety and efficacy of elective EEGBT performed using LAMS stent with electrocautery-enhanced delivery system, followed by intra-cholecystic endoscopic interventions when needed in elderly patients with benign gallbladder diseases at high surgical risk, in whom an indication to perform cholecystectomy was indicated.
Detailed Description
Laparoscopic cholecystectomy (LC) represents the gold standard for treatment of elective and acute of gallbladder diseases, such as acute cholecystitis (AC). However, in elderly patients or in those with severe comorbidities, urgent LC can be associated with increase morbidity (up to 41%) and mortality (up to 19%). In these patients, placement of a percutaneous gallbladder drainage catheter (PT-GBD) or colecistostomy can be utilized to drain the gallbladder until infection is resolved, as a bridge to subsequent surgery or as definitive treatment.4 PT-GBD, however, is associated with major adverse events (AEs), such as intra-hepatic hemorrhage, pneumothorax, biliary peritonitis and pneumonia that occur in about 6.2% of patients. Moreover, PT-GBD has several disadvantages including risk of bile leak from the site of drainage, AC recurrency, self-removal of the drainage by the patient e/o for spontaneous migration (0-25%), with the need for a repeat procedure to reposition the drainage catheter. Finally, percutaneous drainage causes discomfort for the patient, it is often associated with localized pain at the placement site, and can be felt as a cosmetic disfigurement. Recently, to overcome PT-GBD limitations, EUS-guided gallbladder drainage (EUS-GBD) has been introduced as an alternative minimally invasive therapeutic intervention for treatment of patients with high surgical risk who present with AC. This procedure has been strongly facilitated by the introduction of lumen-apposing metal stents (LAMSs), allowing adherence of the mobile gallbladder with the gastric/duodenal lumen and formation of a permanent fistulous tract through which therapeutic maneuvers are feasible, rendered EUS-GBD highly safe. The procedure has high technical and clinical success rates and favorable safety profile, with low risk of recurrent AC. Several retrospective studies and meta-analyses favored EUS-GBD over PTGBD. However, recently updated Tokyo guidelines still prefer PT-GBD as a primary treatment for high surgical risk AC patients, leaving EUS-GBD as a valid option only for experienced endosonographers working in high volume centers. approach has been utilized even in relatively EUS-GBD, followed, when needed, by intra-cholecystic endoscopic interventions has been utilized even in young patients as recently reported in a very provocative case series,that demonstrated successful intra-cholecystic giant stones clearance through the LAMS using previously described endoscopic laser lithotripsy in five patients with a mean age of 50 years, who rejected surgery and desired gallbladder preservation. After removal of LAMS, the fistula was closed with clips or spontaneously, with no gallstone recurrence in any patient after a mean 8-month follow-up. A second category of patients who might benefit from EEGBT are elderly individuals with cardiac, respiratory and other major comorbidities posing them at high surgical risk, who suffer from previous episodes of cholecystitis, recurrent colic episodes due to gallbladder stones, or with biliary acute pancreatitis due to stones migration. Based on all the above considerations, we have designed a prospective, pilot study to evaluate the safety (i.e., adverse events rate) and efficacy (i.e., clinical success rate) of elective EEGBT performed using LAMS stent with electrocautery-enhanced delivery system, followed by intra-cholecystic endoscopic interventions when needed in elderly patients with benign gallbladder diseases at high surgical risk, in whom an indication to perform cholecystectomy was indicated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis, Cholecystitis, Chronic
Keywords
Eus guided gallbladder drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic ultrasound-guided gallbladder treatment
Arm Type
Experimental
Arm Description
Endoscoipc gallbladder drainage under EUS guide using lumen apposing metal stents (LAMS) followed when needed by endoscopic lithotripsy.
Intervention Type
Procedure
Intervention Name(s)
elective endoscopic gallbladder treatment
Intervention Description
Access to the gallbladder will be performed from the stomach or duodenum using LAMS with electrocautery-enhanced delivery system such as Hot Axios, Boston Scientifics device or Hot Spaxus, Taewoong at the discretion of the endoscopist. A stent of 10 mm in diameter will be used if the largest gallstone will be smaller than 10 mm in size while greater diameter (≥15 mm stent) will be used if the largest gallstone will be larger than 10mm. Colecystoscopy lithotripsy will be performed, when needed, using mechanical lithotripsy and/or laser lithotripsy at the discretion of the endoscopist. First cholecystoscopy will be done 2 weeks after the index procedure
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs) after EUS-guided gallbladder treatment
Description
AEs will be classified as procedural when they occur during the procedure; post-procedural when they will occur up to 14 days after the procedure; late when they will occur more than 14 days after the procedure. Minor AEs will be those that need no therapy and have no sequelae (A) or have minor therapy or consequence, including overnight admission (B). Major events include those that require major therapy or hospitalization (24- 48 hours) (C); major therapy, need unplanned increase in level of care, or hospitalization >48 hours (D); or result in permanent adverse sequelae (E) and death (F).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of Technical success
Description
Number of patients achieving successful placement of the LAMS stent between the gastric/duodenal cavity and the gallbladder
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Age ≥75 years Benign gallbladder diseases with an indication to perform cholecystectomy high surgical risk (ASA score ≥3) Signed written informed consent Exclusion criteria Patients unwilling to undergo follow-up assessments Age <75 years Low surgical risk (ASA score <3) Patients with suspected gangrene or perforation of the gallbladder Ongoing acute cholecystitis Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and/or duodenum Abnormal coagulation (INR > 1.5 and/or platelets < 50.000/mm3) Contraindication to perform endoscopy Inability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Larghi
Phone
+390630156580
Email
alberto.larghi@yahoo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Larghi
Organizational Affiliation
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Larghi
Phone
+390630156580
Email
alberto.larghi@yahoo.it

12. IPD Sharing Statement

Learn more about this trial

Elective Endoscopic Gallbladder Treatment: Pilot Study

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