Status:
COMPLETED
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
Lead Sponsor:
Stockholm South General Hospital
Conditions:
Biliary Tract Neoplasms
Pancreatic Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 caus...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00980889
Start Date
May 1 2009
End Date
May 1 2013
Last Update
April 8 2014
Active Locations (11)
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1
Department of Surgery, Upper GI Div. South Hospital,
Stockholm, SLL, Sweden, 118 83
2
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, 41345
3
Länssjukhuset Ryhov
Jönköping, Sweden, 551 85
4
Länssjukhuset i Kalmar
Kalmar, Sweden, 391 85