Advertisement

Topics

Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

2014-07-23 21:11:17 | BioPortfolio

Summary

This is a single center, randomized, unblinded study to compare the rate of occlusion of plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare occlusion rates between uncovered metal and fully covered metal biliary stents in those patients determined to have surgically unresectable disease.

Description

Malignant biliary obstruction can result from extrinsic processes, such as proximal pancreatic ductal adenocarcinoma or metastatic lesions, or from intrinsic lesions such as cholangiocarcinoma. Malignant biliary obstruction is typically treated endoscopically with placement of either plastic (polyethylene) or metal biliary stents. Metal stents have a wider diameter than plastic stents, and have been shown to have higher patency rates, but are also 15-40 times the cost of plastic stents. Metal stents with a polymer coating have been developed to prevent tumor ingrowth into the stent, which can lead to stent occlusion. Cost analysis has demonstrated an advantage to the use of metal stents in patients with unresectable disease, or who may achieve operable status following neoadjuvant chemotherapy, while either plastic stents or metal stents are used when patients are deemed to have a surgically resectable lesion. Patient's determined to have resectable, or borderline resectable malignancy (those who may achieve resectability status following neoadjuvant chemotherapy) will receive either plastic, uncovered metal, or covered metal stents in a randomized fashion, while patients determined to have surgically unresectable malignancy will randomly receive either covered or uncovered metal biliary stents. The primary aim of this study is to prospectively evaluate stent occlusion rates in patients presenting with malignant biliary obstruction. Secondary aims of the study will include a cost analysis of each stent type, rate of hospital admission following stent placement, days off of chemotherapy due to procedural complication, and rate of acute cholecystitis associated with stent placement.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Malignant Biliary Obstruction

Intervention

Biliary stent placement

Location

Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
United States
03756

Status

Recruiting

Source

Dartmouth-Hitchcock Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:17-0400

Clinical Trials [1840 Associated Clinical Trials listed on BioPortfolio]

A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with pl...

Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures.

The purpose of this study is to compare the duration of stent patency of a covered vs. an uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction in pat...

Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve

Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids thr...

Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction

The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency...

Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction

Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.

PubMed Articles [3634 Associated PubMed Articles listed on BioPortfolio]

Side-by-side partially covered self-expandable metal stent placement for malignant hilar biliary obstruction.

 This study investigated the feasibility of side-by-side (SBS) partially covered self-expandable metal stent (PCSEMS) placement for unresectable malignant hilar biliary obstruction (MHBO).

Efficacy of EUS- and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study.

ERCP-guided biliary drainage (ERCP-BD is a criterion standard treatment for malignant biliary obstruction when curative surgery is not an option. Alternative methods such as PTBD would significantly l...

Preoperative biliary drainage for malignant biliary obstruction: results from a national database.

The impact of preoperative biliary drainage (PBD) on postoperative morbidity and mortality in patients with malignant biliary obstruction is still unclear. We examined short-term surgical outcomes amo...

Multicenter study of endoscopic preoperative biliary drainage for malignant hilar biliary obstruction: E-POD Hilar study.

Endoscopic nasobiliary drainage (ENBD) is often recommended in preoperative biliary drainage (PBD) for hilar malignant biliary obstruction (MBO) but endoscopic biliary stent (EBS) is also used in the ...

Covered versus uncovered self-conformable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study.

Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstruction. We aimed to compare stent patency, adverse events rate and overall survival of covered (Niti-S Biliary ComVi) ve...

Medical and Biotech [MESH] Definitions

Abnormal passage in any organ of the biliary tract or between biliary organs and other organs.

FIBROSIS of the hepatic parenchyma due to obstruction of BILE flow (CHOLESTASIS) in the intrahepatic or extrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC; BILE DUCTS, EXTRAHEPATIC). Primary biliary cirrhosis involves the destruction of small intra-hepatic bile ducts and bile secretion. Secondary biliary cirrhosis is produced by prolonged obstruction of large intrahepatic or extrahepatic bile ducts from a variety of causes.

Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.

Progressive destruction or the absence of all or part of the extrahepatic BILE DUCTS, resulting in the complete obstruction of BILE flow. Usually, biliary atresia is found in infants and accounts for one third of the neonatal cholestatic JAUNDICE.

Infection of the biliary passages with CLONORCHIS SINENSIS, also called Opisthorchis sinensis. It may lead to inflammation of the biliary tract, proliferation of biliary epithelium, progressive portal fibrosis, and sometimes bile duct carcinoma. Extension to the liver may lead to fatty changes and cirrhosis. (From Dorland, 27th ed)

More From BioPortfolio on "Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Pancreatitis
Pancreatitis Acute pancreatitis is inflammation of the pancreas caused by the release of activated pancreatic enzymes. Common triggers are biliary tract disease and chronic heavy alcohol intake.  Diagnosis is based on clinical presentation...


Searches Linking to this Trial