Clinical Trials Logo
  1. Home
  2. Biliary Obstruction
  3. NCT04723199

Feasibility of EUS-guided Biliary Drainage With LAMS for the Treatmentof Patients With Distal Malignant Biliary Obstruction — SPAXUS  

Biliary Obstruction Clinical Trial

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)

Clinical Trial 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 (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 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 98.2 %, clinical success of 96.4 %, 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04723199
Study type Observational
Source Istituto Clinico Humanitas
Contact Benedetto Mangiavillano, MD
Phone (+39) 0331 476205 - 381
Email benedetto.mangiavillano@mc.humanitas.it
Status Recruiting
Phase
Start date December 16, 2020
Completion date December 31, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03118973 - Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs N/A
Recruiting NCT05429203 - Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope N/A
Completed NCT03002051 - EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent N/A
Terminated NCT00990366 - Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve N/A
Recruiting NCT04929821 - UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures N/A
Completed NCT03074201 - Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP N/A
Recruiting NCT01524146 - Photodynamic Therapy (PDT) Cholangiocarcinoma Registry N/A
Recruiting NCT01522573 - T-EUS for Gastrointestinal Disorders: A Multicenter Registry N/A
Completed NCT04595058 - LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent N/A
Completed NCT03962478 - Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction N/A
Completed NCT02460432 - Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III) N/A
Active, not recruiting NCT03997994 - DIGEST I Drug Coated Balloon for Biliary Stricture N/A
Completed NCT03870386 - EUS Biliary Drainage vs. ERCP N/A
Not yet recruiting NCT06287112 - Prevention of Acute Cholecystitis With ETGBD N/A
Completed NCT03925766 - Laparoscopy-Assisted Transgastric ERCP
Recruiting NCT00731419 - Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice Phase 4
Not yet recruiting NCT05432661 - clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents
Recruiting NCT06047990 - Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction N/A
Recruiting NCT04857424 - Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction
Completed NCT04319302 - Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.