Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| steel | Active Comparator | Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction |
|
| Nitinol | Active Comparator | Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steel | Device | ERCP procedure insertion of Metalic Steel Stent, Wallstent® |
|
| Measure | Description | Time Frame |
|---|---|---|
| confirmed stent failure | 300 days follow up |
| Measure | Description | Time Frame |
|---|---|---|
| safety with respective stent in trial at insertion and afterwards(complic.) | 300 days | |
| Survival | Survival difference between two groups | 300 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
prior BD stent inserted (metal stent or plastic stent >1month).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claes soderlund, assist prof | south hospital, stockholm sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Upper GI Div. South Hospital, | Stockholm | SLL | 118 83 | Sweden | ||
| Sahlgrenska Universitetssjukhuset |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25321620 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nitinol | Device | Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction |
|
|
| Gothenburg |
| 41345 |
| Sweden |
| Länssjukhuset Ryhov | Jönköping | 551 85 | Sweden |
| Länssjukhuset i Kalmar | Kalmar | 391 85 | Sweden |
| Blekingesjukhuset | Karlskrona | Sweden |
| Centralsjukhuset i Kristianstad | Kristianstad | 29185 | Sweden |
| Universitetssjukhuset i Lund | Lund | 221 85 | Sweden |
| Universitetssjukhuset i Malmö, | Malmö | Sweden |
| dept surgery, South Hospital-Karolinska Institute | Stockholm | se 118 83 | Sweden |
| Claes.Soderlund | Stockholm | se 11883 | Sweden |
| Vasteraslasarett | Västerås | Sweden |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D002779 | Cholestasis |
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001649 | Bile Duct Diseases |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided