NCT05271994: DC LAMS

Fesibility of EUS-guided Gallbladder Drainage With a New-type of Electrocautery LAMS in the Treatment of Malignant Distal Biliary Obstruction

Status unknown Last updated 1 April 2022

What this trial tests

trial testing endoscopic biliary drainage in Distal Malignant Biliary Obstruction in 30 participants. Status unknown.

Timeline

1 February 2022

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Istituto Clinico Humanitas Mater Domini
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 February 2022
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across Italy

Drugs / interventions tested

• endoscopic biliary drainage

Conditions studied

• Distal Malignant Biliary Obstruction — all drugs for Distal Malignant Biliary Obstruction →

Sponsor

Istituto Clinico Humanitas Mater Domini

Who can join

18 and older, any sex, with Distal Malignant Biliary Obstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 (i.e., 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 stays 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 LAMS 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 98.2 %, clinical success of 96.4 %, and low rate of complications 7 % (duodenal perforations, bleeding and transient cholangitis) \[6\]. A systematic review and meta-analyses showed clinical and technical success rates of 87% and 95% respectively \[7\]. Currently, the EUS-BD is indicated as a rescue therapy for jaundice palliation after ERCP failure. Actually, only a retrospective series is published in literature about the gallbladder (GB) drainage in patients with malignant biliary obstruction (MBO), demonstrating the feasibility of gallbladder drainage to relieve malignant distal bile duct obstruction in patients with failed ERCP. No data are actually reported, especially in a prospective way, about the GB drainage as first intention in patients with MBO.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.