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unilateral metal stent insertion was performed either left or right hepatic lobe as can be drainage more liver volume

percutaneous transhepatic biliary drainage plus bilateral metal stent.The bare stents were used for PTBS

bilateral metal stent insertion

unilateral metal stent insertion

Guohong Han, MD,Ph.D

MingWu Li, MD

guohong han, M.D.

mingwu Li, M.D.

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was presented in the area of the biliary duct bifurcation. Recent retrospective study included heterogeneous group of malignant diseases demonstrate that draining more than 50% of was associated with a longer median survival.

However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due to the absence of randomized controlled trials.

Patients with advanced hilar obstruction (Bismuth III and IV), PTBS had a higher success rate of cholestasis palliation and a low rate of post cholangitis when compared with endoscopic retrograde cholangiopancreatography(ERCP). The advantage of percutaneous approach is the precise lobar selection for drainage and this approach should yield a lower rate of cholangitis.

Guideline recommendation European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations the goal of palliative stenting of HCCA is drainage of adequate liver volume (50% or more), irrespective of unilateral, bilateral, or multi-segmental stenting was based on heterogeneous group of malignancy by ERCP in retrospective study.There are no randomized clinical trials compared with these two internal biliary drainage methods in HCCA using metal stent.

The aim of the present study was to compare the effect and safety of bilateral versus unilateral stenting in patients with HCCA.

Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

Percutaneous Bilateral Versus Unilateral Metal Stent Placement for Hilar Cholangiocarcinoma : A Prospective Open-label Randomized Controlled Trial

Stent patency is a secondary endpoint of this study. Cumulative stent patency rate is compared between the two groups.

Early major complications is a secondary endpoint of this study.Early major complications rate is compared between the two groups

30-day mortality is a secondary endpoint of this study. 30-day mortality rate is compared between the two groups.

Air Force Military Medical University, China

Head of Department of Digestive Interventional Radiology

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Cholestasis

Gallbladder Neoplasms

Bile Duct Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Bile Duct Diseases

Pancreatic Cancer

Gallbladder Cancer

Reproductive Control Agents

Ulipristal acetate

Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm

"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)

Eric P Kullman, M.D.

Claes Soderlund, M.D.

Bo Ohlin, M.D.

Ervin Toth, M.D.

Carl-Eric Leijonmarck, M.D.

Eduard Jonas, M.D.

Claes Rudberg, M.D.

Kalev Teder, M.D.

Erik Svartholm, M.D.

Mehmet Gozen, M.D.

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 of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.

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

Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.

University Hospital, Linkoeping

Eric Kullman, M.D., Associate Professor

Metallic stent deployment in hilar obstruction. Insertion of metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV).

Metallic stent deployment in hilar obstruction. Insertion of multiple metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV).

Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment

Metallic stent deployment in hilar obstruction

Tae Hoon Lee, MD, PhD

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.

However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.

The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

First as an unilateral or bilateral stent will be deployed according to criteria.

In bilateral group, stent-in-stent or side-by-side deployment will be included.

Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction

Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study

When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.

When the bilirubin level decrease more than 50% within one week or 75% within one month.

Soon Chun Hyang University

Professor

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction

Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction

ERCP procedure insertion of Metalic Steel Stent, Wallstent®

Steel

Nitinol

Claes soderlund, assist prof

Less than 20% of patients with malignant distal bile duct (BD) obstruction (often pancreatic cancer) are suitable for resection surgery.In the rest,palliation treatment comes into focus. Jaundice caused by BD obstruction gives pain, infection (cholangitis), often itching and increased weight loss, and the patient is stigmatized by the deep yellow colour of the skin.Therefore palliation with endoscopic stenting by ERCP-technique is important. Modern self-expanding metal stents (SEMS) are now widely used in this context. Comparison in a RCT between steel and nitinol SEMS has never been performed.

The steel stent (Wallstent®) is the "original",is widely used, and has more expanding power. Nitinol stents are softer and claimed to be easier to insert,and are more and more popular.A newly developed nitinol stent (Wallflex®)may have these advantages, but is some 120 Euros more expensive.

Regarding the most important outcome measure, time to stent failure (obstruction), no one knows if there is any difference.Our hypothesis is that there is no difference in this main outcome endpoint.

Secondary outcome measures (compare above) are complications caused by the stent or stent insertion and technical ease to insert the stent. To discover a 12% difference between the 2 groups, regarding patency, 400 patients must be included in the trial, alfa 0.05, beta 0.8. Investigators know from previous trials (Single center trial South Hospital GIE 2006;63:986-995 and a newly finished similar swedish multicenter trial,prel data DDW- 09)that the 9 hospitals recruited will be able to include this no of patients in approximately 2.5 years.

Investigators will have a shortest follow-up period of 10 months, followup will be by phone with standard questions connected to stent failure, which is defined clinically AND by a new ERCP with intervention because of an obstructed stent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma	NCT02108145	Hilar Cholangio...	bilateral metal... unilateral meta...	18 Years - 90 Years	Air Force Military Medical University, China
Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction	NCT00280709	Bile Duct Obstr... Pancreatic Canc... Gallbladder Can... Bile Duct Cance...	"Nitinella" ; S...	20 Years -	University Hospital, Linkoeping
Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction	NCT02166970	Klatskin Tumor	Metallic stent ...	18 Years -	Soon Chun Hyang University
Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction	NCT02166970	Klatskin Tumor	Metallic stent ...	18 Years -	Soon Chun Hyang University
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction	NCT00980889	Biliary Tract N... Pancreatic Neop... Stent Occlusion	Steel Nitinol	20 Years -	Stockholm South General Hospital
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction	NCT00980889	Biliary Tract N... Pancreatic Neop... Stent Occlusion	Steel Nitinol	20 Years -	Stockholm South General Hospital

Spots Global Cancer Trial Database for metal stent

Every month we try and update this database with for metal stent cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for metal stent

Every month we try and update this database with for metal stent cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for metal stent cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.