Biliary Tract NeoplasmsPhase 4NCT00980889
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
A Phase 4 study testing Steel and Nitinol in people with Biliary Tract Neoplasms and Pancreatic Neoplasms, run by Stockholm South General Hospital at 11 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Stent Occlusion
- What is being tested?
- Steel and Nitinol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 11 sitesSweden
- Study dates
- May 2009to May 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Sweden11 sites
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345
Länssjukhuset Ryhov
Jönköping, 551 85
Länssjukhuset i Kalmar
Kalmar, 391 85
Blekingesjukhuset
Karlskrona
Centralsjukhuset i Kristianstad
Kristianstad, 29185
Universitetssjukhuset i Lund
Lund, 221 85
Universitetssjukhuset i Malmö,
Malmö
Department of Surgery, Upper GI Div. South Hospital,
Stockholm, SLL, 118 83
dept surgery, South Hospital-Karolinska Institute
Stockholm, se 118 83
Claes.Soderlund
Stockholm, se 11883
Vasteraslasarett
Västerås
About this study
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.
Read the 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.
- Being tested
- Steel, Nitinol
- Keywords
- bile duct obstruction, jaundice, metal stent
- Medical subject headings
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Cholestasis, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteelDevice
Also called Wallstent®
ERCP procedure insertion of Metalic Steel Stent, Wallstent®
NitinolDevice
Also called Wallflex
Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction
| Study group | Role | What they receive |
|---|---|---|
| steel | Active comparator | Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction Receives: Device: Steel |
| Nitinol | Active comparator | Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction Receives: Device: Nitinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
confirmed stent failure
Measured: 300 days follow up
Secondary outcomes (2)
safety with respective stent in trial at insertion and afterwards(complic.)
Measured: 300 days
Survival
Survival difference between two groups
Measured: 300 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm South General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, claes soderlund, Stockholm South General Hospital
- Investigators
- Claes soderlund, assist prof, Principal investigator, south hospital, stockholm sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980889
- Sponsor's protocol ID
- Steel vs nitinol
- Status last verified
- Apr 2014
- First submitted
- 18 Sep 2009
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25321620
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
- ClinicalTrials.gov ID
- NCT00980889
- Acronym / sponsor ID
- Steel vs nitinol
- Keywords
- bile duct obstruction, jaundice, metal stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Stockholm South General HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steel | Active comparator | Device: SteelInsertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction |
| Nitinol | Active comparator | Device: NitinolInsertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SteelAlso: Wallstent®ERCP procedure insertion of Metalic Steel Stent, Wallstent® | Device | steel |
| NitinolAlso: WallflexInsertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction | Device | Nitinol |
Primary outcome
confirmed stent failure
Time frame: 300 days follow up
2 secondary outcomes
safety with respective stent in trial at insertion and afterwards(complic.)
Time frame: 300 days
Survival
Time frame: 300 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Derived from this study: PubMed 25321620Soderlund 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.
Related trials for Biliary Tract Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claes soderlund, assist prof principal investigator
south hospital, stockholm sweden
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Steel and Nitinol in people with Biliary Tract Neoplasms and Pancreatic Neoplasms, run by Stockholm South General Hospital at 11 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
confirmed stent failure (time frame: 300 days follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00980889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.