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

NCT00980889 | Completed Phase 4 DMC

• 1 other identifier: Steel vs nitinol
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 11

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.

Conditions

Biliary Tract Neoplasms; Pancreatic Neoplasms; Stent Occlusion

Keywords

bile duct obstruction; jaundice; metal stent

Outcome Measures

Primary Outcomes (1)

• confirmed stent failure

  300 days follow up

Secondary Outcomes (2)

• safety with respective stent in trial at insertion and afterwards(complic.)

  300 days

• Survival

  300 days

Study Arms (2)

steel

ACTIVE COMPARATOR

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

Device: Steel

Nitinol

ACTIVE COMPARATOR

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

Device: Nitinol

Interventions

Steel DEVICE

ERCP procedure insertion of Metalic Steel Stent, Wallstent®

Also known as: Wallstent®

steel

Nitinol DEVICE

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

Also known as: Wallflex

Nitinol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stockholm South General Hospital: lead

Study Sites (11)

Department of Surgery, Upper GI Div. South Hospital,

Stockholm, SLL, 118 83, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 41345, Sweden

Location

Länssjukhuset Ryhov

Jönköping, 551 85, Sweden

Location

Länssjukhuset i Kalmar

Kalmar, 391 85, Sweden

Location

Blekingesjukhuset

Karlskrona, Sweden

Location

Centralsjukhuset i Kristianstad

Kristianstad, 29185, Sweden

Location

Universitetssjukhuset i Lund

Lund, 221 85, Sweden

Location

Universitetssjukhuset i Malmö,

Malmo, Sweden

Location

dept surgery, South Hospital-Karolinska Institute

Stockholm, se 118 83, Sweden

Location

Claes.Soderlund

Stockholm, se 11883, Sweden

Location

Vasteraslasarett

Västerås, Sweden

Location

Related Publications (1)

• Soderlund C, Linder S, Bergenzaun PE, Grape T, Hakansson HO, Kilander A, Lindell G, Ljungman M, Ohlin B, Nielsen J, Rudberg C, Stotzer PO, Svartholm E, Toth E, Frozanpor F. Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial. Endoscopy. 2014 Nov;46(11):941-8. doi: 10.1055/s-0034-1377936. Epub 2014 Oct 16.

  PMID: 25321620 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms; Pancreatic Neoplasms; Cholestasis; Jaundice

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Bile Duct Diseases; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Claes soderlund, assist prof

  south hospital, stockholm sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stockholm South General Hospital

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: May 1, 2013
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

SE (11)