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

Sponsor

Stockholm South General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00980889

Collaborator

(none)

400

Enrollment

Locations

Arms

Duration (Months)

36.4

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Neoplasms Pancreatic Neoplasms Stent Occlusion	Device: Steel Device: Nitinol	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: steel Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction	Device: Steel ERCP procedure insertion of Metalic Steel Stent, Wallstent® Other Names: Wallstent®
Active Comparator: Nitinol Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction	Device: Nitinol Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction Other Names: Wallflex

Arm

Intervention/Treatment

Active Comparator: steel

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

Device: Steel

ERCP procedure insertion of Metalic Steel Stent, Wallstent®

Other Names:

Wallstent®

Active Comparator: Nitinol

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

Device: Nitinol

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

Other Names:

Wallflex

Outcome Measures

Primary Outcome Measures

confirmed stent failure [300 days follow up]

Secondary Outcome Measures

safety with respective stent in trial at insertion and afterwards(complic.) [300 days]
Survival [300 days]
Survival difference between two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

pt more than 20yrs.
BD stenosis at least 2cm distal of the hepatic hilum, with typical malignant exposure radiologically.
Clinically in accordance with tumour.s-bilirubin more than 50 micromol per litre.
Radical surgery probably not possible(temporary-1month-plastic stenting for further investigation and then exchange to SEMS if estimated non-operable, after Rx is allowed).
The patient must be fully informed by his doctor orally and in writing prior to the procedure, and give her/his informed consent. Ultrasound or CT examination must be performed prior to Rx.

Exclusion Criteria:

Informed consent not obtained.
Significant multiple intrahepatic stenosis by multiple tumour growth, not suitable for ERCP stenting.
Radical Surgery will probably take place. Suspicion of non-malignant obstruction-further investigation must be performed.
Not possible by anatomical reasons to reach the papilla, i.e because of prior operations.

prior BD stent inserted (metal stent or plastic stent >1month).

Previously included in this trial. Prothrombin index more than 1.5. (normal <1.1).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Upper GI Div. South Hospital,	Stockholm	SLL	Sweden	118 83
2	Sahlgrenska Universitetssjukhuset	Göteborg		Sweden	41345
3	Länssjukhuset Ryhov	Jönköping		Sweden	551 85
4	Länssjukhuset i Kalmar	Kalmar		Sweden	391 85
5	Blekingesjukhuset	Karlskrona		Sweden
6	Centralsjukhuset i Kristianstad	Kristianstad		Sweden	29185
7	Universitetssjukhuset i Lund	Lund		Sweden	221 85
8	Universitetssjukhuset i Malmö,	Malmö		Sweden
9	dept surgery, South Hospital-Karolinska Institute	Stockholm		Sweden	se 118 83
10	Claes.Soderlund	Stockholm		Sweden	se 11883
11	Vasteraslasarett	Vasteras		Sweden