Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05272007
Status:
RECRUITING
Last Update Posted:
2022-04-01
First Post:
2022-02-28
Brief Title:
Endoscopic Ultrasonography EUS Guided Gallbladder Drainage With Two Months Stent Removal for Acute Cholecystitis a Prospective Study
Sponsor:
Istituto Clinico Humanitas Mater Domini
Organization:
Istituto Clinico Humanitas Mater Domini
Study Overview
Official Title:
Endoscopic Ultrasonography EUS Guided Gallbladder Drainage With Two Months Stent Removal for Acute Cholecystitis a Prospective Study
Status:
RECRUITING
Status Verified Date:
2022-03
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:
AC LAMS
Brief Summary:
Acute cholecystitis AC is defined as an acute inflammatory disease of the gallbladder consequently to the presence of sludge or stones AC accounts for 3-10 of all cases of abdominal pain Cholecystolithiasis accounts for 90-95 of all causes of acute cholecystitis while acalculous cholecystitis accounts for the remaining 5-10 of the cases Laparoscopic cholecystectomy is actually the gold standard treatment for acute cholecystitis AC although it is always not suitable for patients who are poor candidates for surgery In 2001 Giovannini et al described the first EUS-guided biliary drainage EUS-BD through a transduodenal access with a needle knife Subsequently EUS-BD has considerably evolved thanks to the development of dedicated devices such as lumen apposing metal stents LAMS specifically designed for endoscopic ultrasound procedures LAMS are made up of braided nitinol that is fully covered with silicone to prevent tissue ingrowth with wide flanges on both ends to provide anchorage
Recently LAMS have been incorporated into a delivery system with an electrocautery mounted on the tip which allows the device to be used directly to penetrate the target structure without the need to utilize a 19G needle a guidewire and a cystotome for prior dilation Different are actually the indication of the LAMS for different disease and its use has been described for drainage of peri-pancreatic fluid collections common bile duct CBD gallbladder and for creation of gastro-jejuno anastomosis
Recently endoscopic gallbladder GB drainage was found to be a potentially revolutionary alternative for cholecystectomy for the control of symptoms definitive treatment or bridging therapy until surgery is possible
Before the advent of LAMS the standard of care of acute cholecystitis AC was the percutaneous drainage PTC and after the advent of these new stents different series showed the higher technical and clinical success of the EUS-gallbladder drainage EUS-GB for acute cholecystitis with a lower recurrence rate than PTC The superiority of this technique was assessed in terms of technical and clinical success AEs and AC recurrence if compared to the endoscopic drainage This could be explained with the use of larger caliber stents allowing an effective drainage with low risk of stent occlusion Finally a recent study with a long-term follow-up showed as the outcomes of EUS-GBD for AC were comparable with LC with acceptable rates of recurrent acute cholecystitis
Recently LAMS have been incorporated into a delivery system with an electrocautery mounted on the tip which allows the device to be used directly to penetrate the target structure without the need to utilize a 19G needle a guidewire and a cystotome for prior dilation Different are actually the indication of the LAMS for different disease and its use has been described for drainage of peri-pancreatic fluid collections common bile duct CBD gallbladder and for creation of gastro-jejuno anastomosis
Recently endoscopic gallbladder GB drainage was found to be a potentially revolutionary alternative for cholecystectomy for the control of symptoms definitive treatment or bridging therapy until surgery is possible
Before the advent of LAMS the standard of care of acute cholecystitis AC was the percutaneous drainage PTC and after the advent of these new stents different series showed the higher technical and clinical success of the EUS-gallbladder drainage EUS-GB for acute cholecystitis with a lower recurrence rate than PTC The superiority of this technique was assessed in terms of technical and clinical success AEs and AC recurrence if compared to the endoscopic drainage This could be explained with the use of larger caliber stents allowing an effective drainage with low risk of stent occlusion Finally a recent study with a long-term follow-up showed as the outcomes of EUS-GBD for AC were comparable with LC with acceptable rates of recurrent acute cholecystitis
Detailed Description:
None
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