Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05723224
Status:
RECRUITING
Last Update Posted:
2023-02-10
First Post:
2023-02-01
Brief Title:
Elective Endoscopic Gallbladder Treatment Pilot Study
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Elective Endoscopic Gallbladder Treatment in Elderly Patients With Benign Gallbladder Diseases at High Surgical Risk a Prospective Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLATAN
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 eo 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
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 treatment4 PT-GBD however is associated with major adverse events AEs such as intra-hepatic hemorrhage pneumothorax biliary peritonitis and pneumonia that occur in about 62 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 eo 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 gastricduodenal 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 seriesthat 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 ie adverse events rate and efficacy ie 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
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 seriesthat 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 ie adverse events rate and efficacy ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None