Elective Endoscopic Gallbladder Treatment: Pilot Study

NCT05723224 | Unknown

• 1 other identifier: 4569
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystolithiasis; Cholecystitis, Chronic

Keywords

Eus guided gallbladder drainage

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (1)

• Rate of Technical success

  1 year

Study Arms (1)

Endoscopic ultrasound-guided gallbladder treatment

EXPERIMENTAL

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

Procedure: elective endoscopic gallbladder treatment

Interventions

elective endoscopic gallbladder treatment PROCEDURE

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

Endoscopic ultrasound-guided gallbladder treatment

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥75 years
• Benign gallbladder diseases with an indication to perform cholecystectomy
• high surgical risk (ASA score ≥3)
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Cholecystolithiasis; Cholecystitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Alberto Larghi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Larghi

CONTACT

+390630156580; alberto.larghi@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: June 14, 2022
• Primary Completion: June 14, 2023
• Study Completion: December 24, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-01

Locations

IT (1)