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Bile Duct Stricture clinical trials

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NCT ID: NCT05320497 Recruiting - Clinical trials for Biliary Tract Neoplasms

Transparent Cap-assisted SpyGlass for Biliary Stricture

Start date: April 14, 2022
Phase: N/A
Study type: Interventional

The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. In this study, the investigators intend to apply transparent cap-assisted choledochoscopy to endoscopic biliary tract exploration and biopsy to investigate whether transparent cap-assisted choledochoscopy can improve operability, visual field clarity, and biopsy accuracy.

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: NCT03788655 Recruiting - Bile Duct Cancer Clinical Trials

Metal Stents (Moving Cell Stent) for Inoperable Tumors of the Bile Duct Tract

Start date: December 31, 2018
Phase:
Study type: Observational

In this feasibility study (non-randomized), the applicability of a new "moving cell" biliary stents (by HILZO) in Klatskin tumors (bile duct obstruction) will be investigated. The HILZO Moving-Cell Stent to be examined here is a non-coated metal stent with a novelty. The meshes have a diameter of 4 mm, which is rather small compared to most other stents. This significantly increases the radial force and thus the stability of the stent. Furthermore, ingrowth by tumors in the stent is difficult. The special feature is that the individual meshes can easily be stretched to 10 mm without changing the stability of the stent. This allows a second stent to pass through the first to another segment of liver.

NCT ID: NCT03763214 Recruiting - Pancreas Cancer Clinical Trials

PTFE Stents for Treatment of Malignant Biliary Strictures

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

In this randomized trial two two self-expanding metal stents (SEMS) for treatment of malignant biliary strictures are investigated. A newly developed PTFE (Polytetrafluorethylen) (Teflon) stent is tested versus standard covered metal stents. PFTE (Teflon) coating promises improved formability over standard silicone-coated stents, easier removal through the soft surface, and significantly reduced tumor growth through the impermeable surface.

NCT ID: NCT03716232 Recruiting - Biliary Stricture Clinical Trials

Kaffes Stent in the Management of Post-surgical Biliary Strictures

Start date: July 1, 2018
Phase: Phase 3
Study type: Interventional

Post-surgical biliary strictures are common especially after cholecystectomy. Standard treatment involves the performance of multiple procedures over a 1 year period at least using several plastic stents to achieve permanent dilatation of these strictures. Metallic stents have the theoretical benefit of absence of need of multiple sessions. These strictures however are frequently very close to the hilum and thus previously considered a contraindication for insertion of metallic stents for the fear of occlusion of the contralateral ducts. Metallic stent migration is also a frequent problem. The use of a metallic stent that is short and completely intraductal, in theory, should reduce the risk of stent migration. This is a randomized controlled trial comparing the efficacy and safety of a short metallic intraductal stent to the conventional treatment which is multiple plastic stents. In cases with a stricture reaching or close to the hilum a technique is used to avoid obstruction of the contralateral ducts which is insertion of a 7 French plastic stent alongside the metallic stent.

NCT ID: NCT03310554 Recruiting - Bile Duct Stricture Clinical Trials

Suspended Overlength Biliary Stents Preventing Duodenobiliary Reflux in Patients With Biliary Stricture

Start date: January 11, 2018
Phase: N/A
Study type: Interventional

Endoscopic insertion of plastic or metal stents in bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of distal malignant biliary obstruction.Biliary stents are widely used to relieve symptoms of malignant biliary stricture.Now, the mainly used biliary stents include plastic and metal stents. The main limitation of long time plastic stents is stents occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion, yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents occlusion include biliary sluge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents and the presure in bile duct lowers the duodenals, which cause the retrograde flow of duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is gradually concerned by clinical researchers. Some studies have showed that plastic stents with antireflux valves can effectively reduce the biliary stent stricture and prolong the stents patency, which means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency.So,we assume to explore an innovatively suspended overlength biliary stents (made from nasobiliary tube with length of 26cm or 30cm) as substitution for ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In this study,we will design a randomized controlled trial to compare the patency of different length of suspended overlength biliary stents and ordinary plastic biliary stents in patients with distal malignant biliary obstruction to evaluate the effect and safety of suspended overlength biliary stents for the prevention of duodenobiliary reflux and the effect of different length of the stents.

NCT ID: NCT01818050 Recruiting - Bile Duct Stricture Clinical Trials

Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaductâ„¢)

Start date: March 2013
Phase: Phase 4
Study type: Interventional

Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. Studies have shown that the conventional tubular type polyethylene stents (CS) with side holes accumulate significant sludge and their mean patency is approximately 90 days. Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3 months. Recently, a stent with a star-shaped cross-section has been developed for biliary applications. This FDA approved biliary Wing stent (WS) (ViaDuctâ„¢) is a novel plastic biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent. The stent which is star shaped in cross section, channels fluid along its winged perimeter. It has been proposed that the winged stent design with a lack of central lumen obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of multiple external drainage channels, is smaller. Longer term biliary drainage without the need for stent exchange should therefore be possible with these stents. The primary aim of this study is to prospectively evaluate the patency rate of the WS up to 90 days in 50 patients with biliary obstruction due to stones or benign strictures.

NCT ID: NCT01414400 Recruiting - Choledocholithiasis Clinical Trials

Prospective Study to Investigate the Frequency of Possible Bacterial Entry Into the Bloodstream (Bacteremia) and Infectious Complications Associated With the Use of the Spyglass Cholangioscopy System During ERCP (Endoscopic Retrograde Cholangiopancreatography).

Start date: August 2011
Phase: N/A
Study type: Interventional

The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.