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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

Symptoms and General Pathology

Jaundice

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.

RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction

Stockholm South General Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
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 stent occlusion