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Malignant Biliary Obstruction clinical trials

View clinical trials related to Malignant Biliary Obstruction.

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NCT ID: NCT06375967 Not yet recruiting - Clinical trials for Biliary Tract Neoplasms

EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

CARPEGIEM
Start date: June 2024
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.

NCT ID: NCT06375954 Not yet recruiting - Pancreatic Cancer Clinical Trials

EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.

NCT ID: NCT06375928 Not yet recruiting - Clinical trials for Biliary Tract Neoplasms

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.

NCT ID: NCT05804201 Not yet recruiting - Clinical trials for Malignant Biliary Obstruction

EUS-guided Hepatico-gastrostomy With Hot Giobor

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

Endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS) is a method of obtaining biliary drainage in patients with failed or difficult endoscopic retrograde cholangiopancreatography (ERCP). The reason for failure of ERCP can be due to gastric outlet obstruction or failed cannulation. HGS involves placement of a stent between the bile duct and the stomach under the guidance of endoscopic ultrasound to create a biliary drainage route similar to surgery. The overall reported success rate is 94% with an overall complication rate of 14%. The most common complications include pneumoperitoneum (air leaking into the abdomen) and bile leak. Both complications are usually managed conservatively. EUS-gudied HGS has been commonly performed but the type of stent used for the procedure is still under evolution. A specific stent is needed to prevent complications. The most commonly used stent in HK is a hybrid stent where the liver portion is uncovered to avoid stent migration and the rest of the stent is covered to avoid bile leakage and pneumoperitonum. This stent is already available and is called the Giobor stent. However, in order to use this stent, during the EUS procedure, the bile duct needs to be first punctured by a EUS needle, then a guidewire passed, then dilate the tract with an energy deviced 6Fr cytotome, then the stent can be passed. This process is cumbersome and increase the chance of complications during exchange of the devices. A newly developed stent that is cautery-fitted has been developed. The use of this stent shortens the steps of stent application. The current study aims to evaluate the feasibility and safety of a novel stent that is cautery-fitted designed for performance of EUS-HGS (Niti-S HOT Giobor).

NCT ID: NCT05786326 Recruiting - Clinical trials for Malignant Biliary Obstruction

Multihole Fully Covered Metallic Stents in the Management of Malignant Biliary Obstruction

Start date: March 28, 2023
Phase: N/A
Study type: Interventional

multiholes fully covered metallic stents in the management of malignant biliary obstruction

NCT ID: NCT05729867 Recruiting - Clinical trials for Hepatocellular Carcinoma

Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC

Start date: April 27, 2020
Phase: N/A
Study type: Interventional

The effectiveness and safety of fully covered metal stent in malignant biliary obstruction caused by HCC are still unknown. These would be clarified in this prospective cohort study.

NCT ID: NCT05233293 Enrolling by invitation - Clinical trials for Malignant Biliary Obstruction

Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in the diagnosis and treatment of extrahepatic cholangiocarcinoma.In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time.The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.

NCT ID: NCT05220475 Recruiting - Clinical trials for Malignant Biliary Obstruction

A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

NCT ID: NCT05169398 Recruiting - Clinical trials for Malignant Biliary Obstruction

EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a malignant bile duct obstruction but the papilla is inaccessible or if the first of the duodenum is infiltrated by tumor. Recently, a novel dedicated HGS (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) has become available, the stent has a novel design to that prevents the stent from migration, further improving the safety. The aim of the current study is to evaluate the feasibility and outcomes of the novel lumen apposing stent for EUS-guided HGS. The hypothesis is that the device is safe and effective.

NCT ID: NCT05142839 Recruiting - Clinical trials for Malignant Biliary Obstruction

Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.

B-GOOD
Start date: December 15, 2021
Phase: N/A
Study type: Interventional

EUS-guided drainages has been largely widespread during the last 10 years, even thanks to the advent of dedicated devices, such as lumen apposing metal stents (LAMSs). Above all, EUS-guided choledochoduodenostomy (EUS-CD) is to date considered a valuable option of treatment in case of distal malignant biliary obstruction in case of failure of endoscopic retrograde cholangiopancreatography (ERCP) due to the presence of a gastric or duodenal obstruction, unreachable papilla in case of altered anatomy, infiltrated papilla or failure of deep cannulation of the common bile duct. This modality of drainage demonstrated satisfying results, with high rate both of technical and clinical success with acceptable rate of adverse events. When the distal malignant biliary obstruction is associated to signs and symptoms of gastric outflow obstruction (GOO) due to the presence of a gastric or duodenal stenosis, a concomitant or subsequent palliation of the stenosis may be required. Recently, EUS-guided gastroenterostomy (EUS-GEA) has been introduced for the palliation of GOO, showing good results although technically challenging. To date, endoscopic treatment in case of GOO, enteral stenting and EUS-GEA are possible alternatives. However, available data demonstrated that EUS-GEA seems to be superior to enteral stenting in terms of rate of reinterventions during long-term follow-up, especially when life expectancy is superior to 6 months. However, data are lacking regarding which is the best strategy when GOO is associated to distal malignant biliary obstruction, especially when EUS-CD is performed. This is an hot topic, as it has been supposed that EUS-CD has higher rate of adverse events, especially food impaction, when a duodenal stenosis is present. The aim of our study, therefore, is to perform a retrospective multicenter study collecting all consecutive patients affect by distal malignant biliary obstruction drained using EUS-CD, with associated GOO treated with concomitant or subsequent duodenal stenting or EUS-GEA, in order to evaluate clinical efficacy, long term outcomes and severity of adverse events.