Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04723199
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2021-01-20
Brief Title:
Feasibility of EUS-guided Biliary Drainage With LAMS for the Treatmentof Patients With Distal Malignant Biliary Obstruction
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Feasibility of EUS-guided Biliary Drainage With a New-type of Eletrocautery LAMS for the Treatmentof Patients With Distal Malignant Biliary Obstruction SPAZUS
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
SPAXUS
Brief Summary:
Distal malignant biliary obstruction results from different types of tumors including pancreatic cancer biliary tract cancer BTC gallbladder cancer and metastasis which can lead to obstructive jaundice Endoscopic retrograde cholangiopancreatography ERCP represents the gold standard for jaundice palliation in this setting of patients However surgically altered anatomy ie Whipple intervention Roux-en-Y gastric bypass Billroth II surgery periampullary diverticula gastric outlet obstruction and malignant obstruction of the lumen determine the failure of the procedure in about 5-10 of cases requiring alternative methods of decompression Percutaneous transhepatic biliary drainage PTBD and surgical bypass are well established alternatives in these patients but associated with increased morbidity longer length of hospital stay and higher costs and patient discomfort
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 Hot Axios Boston Scientific Corp 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 This has been described for drainage of peri-pancreatic fluid collections common bile duct CBD gallbladder and for creation of gastro-jejuno anastomosis The biliary drainage procedure performed with the Hot Axios sistem is a one step procedure that requires less or no need for accessory exchange and becomes faster thus potentially decreasing the risk of complications
The procedure has been described as safe and effective with a technical success of 982 clinical success of 964 and low rate of complications 7 duodenal perforations bleeding and transient cholangitis A systematic review and meta-analyses showed clinical and technical success rates of 87 and 95 respectively Currently the EUS-BD is indicated as a rescue therapy for jaundice palliation after ERCP failure
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 Hot Axios Boston Scientific Corp 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 This has been described for drainage of peri-pancreatic fluid collections common bile duct CBD gallbladder and for creation of gastro-jejuno anastomosis The biliary drainage procedure performed with the Hot Axios sistem is a one step procedure that requires less or no need for accessory exchange and becomes faster thus potentially decreasing the risk of complications
The procedure has been described as safe and effective with a technical success of 982 clinical success of 964 and low rate of complications 7 duodenal perforations bleeding and transient cholangitis A systematic review and meta-analyses showed clinical and technical success rates of 87 and 95 respectively Currently the EUS-BD is indicated as a rescue therapy for jaundice palliation after ERCP failure
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