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Biliary Obstruction clinical trials

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NCT ID: NCT06047990 Recruiting - Biliary Obstruction Clinical Trials

Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

BICRYOB
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.

NCT ID: NCT05886127 Recruiting - Biliary Obstruction Clinical Trials

Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel.

ERCPURA
Start date: August 1, 2022
Phase:
Study type: Observational

The aim of this observational study is to evaluate safety and efficacy of a novel self-assembling peptide hemostatic gel in reduction of bleeding after endoscopic sphincterotomy during ERCP (endoscopic retrograde cholangiopancreatography )

NCT ID: NCT05595122 Recruiting - Biliary Obstruction Clinical Trials

EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction

SCORPION-II-p
Start date: December 2, 2022
Phase: N/A
Study type: Interventional

A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to reduce stent dysfunction.

NCT ID: NCT05429203 Recruiting - Clinical trials for Pancreatic Neoplasms

Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

Start date: October 25, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

NCT ID: NCT04929821 Recruiting - Biliary Obstruction Clinical Trials

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

Start date: October 16, 2017
Phase: N/A
Study type: Interventional

STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY OBJECTIVES Clinical /Technical /Procedural success, Quality of Life improvement, biodegradation rate

NCT ID: NCT04857424 Recruiting - Biliary Obstruction Clinical Trials

Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction

Start date: July 15, 2021
Phase:
Study type: Observational

The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD).

NCT ID: NCT04813055 Recruiting - Clinical trials for Chronic Pancreatitis

Prospective Registry Of Therapeutic EndoscopiC ulTrasound

PROTECT
Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates.

NCT ID: NCT04723199 Recruiting - Biliary Obstruction Clinical Trials

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

SPAXUS
Start date: December 16, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT03903523 Recruiting - Biliary Obstruction Clinical Trials

Efficacy and Safety of Lumen Apposing Metal Stents

LAMS
Start date: April 30, 2019
Phase:
Study type: Observational

Endoscopic ultrasonography (EUS) has revolutioned the management of gastroenterological patients and is acquiring an increasingly important role. The development of specifically designed stents has significantly increased the technical and clinical success rate of the EUS-guided procedures, considerably reducing the rate of adverse events. Currently EUS has a prominent role in drainage of peripancreatic fluid collections and it represents an important therapeutic option for patients with distal malignant biliary obstruction, in which the ERCP fails, allowing the positioning of a transgastric or transbulbar lumen apposing metal stent (LAMS) to drain the biliary duct. Moreover, the EUS-guided gallbladder drainage of patients with high surgical risk and acute cholecystitis, which cannot be operated, is another important therapeutic indication. Our aim is to perform a multicentre retrospective analysis of all types of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of LAMS in order to evaluate the rate of technical and clinical success and to assess the safety profile of these procedures.

NCT ID: NCT02238613 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.