Bile Duct ObstructionPhase 4NCT00280709
Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
A Phase 4 study testing "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent) in people with Bile Duct Obstruction and Pancreatic Cancer, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bile Duct Obstruction, Pancreatic Cancer, Gallbladder Cancer
- What is being tested?
- "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2006to Aug 2010
- 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
- 20 years of age or older
- oral and written information given and informed consent obtained
- clinical data in accordance with malignant bile duct obstruction
- ultrasonography signs of extrahepatic malignant common bile duct obstruction
- typical radiological findings at ERCP of malignant common bile duct stenosis
- proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence
- bilirubin > 50 micromol/L
- radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ERCP procedure, and the patient is randomized at the time of insertion of the metal stent)
Who cannot join
- patients with active hepatitis or other hepatic diseases that may cause jaundice
- informed consent not obtained
- metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria)
- the patient is probably a candidate for surgical resection
- suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
- the proximal end of the stenosis is located within 2 cm from the hepatic confluence
Show all 9Show fewer
- the patient has previously undergone BII or Roux-en-Y gastric resection, or has a significant duodenal obstruction making ERCP difficult
- previously (more than 4 weeks earlier) treated with a bile duct stent
- severe coagulation disturbance (PK-INR > 1.6)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.
The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.
- Being tested
- "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
- Keywords
- Bile duct, Bile duct obstruction, Biliary stent, Metal stent, ERCP, Patency, Complication, Stent occlusion
- Medical subject headings
- Cholestasis, Pancreatic Neoplasms, Gallbladder Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)Device
Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Covered metal stent Receives: Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent) |
| 2 | Active comparator | Uncovered metal stent Receives: Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?
Measured: 12 months after stent insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2008
- Study completionAug 2010
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 Bile Duct ObstructionStudies 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
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Investigators
- Eric P Kullman, M.D., Study chair, Department of Surgery, University Hostpital, Linkoping, Sweden.Claes Soderlund, M.D., Principal investigator, Department of Surgery, Sodersjukhuset, Stockholm, Sweden.Bo Ohlin, M.D., Principal investigator, Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden.Ervin Toth, M.D., Principal investigator, Department of Endoscopy, University Hospital MAS, Malmö, Sweden.Carl-Eric Leijonmarck, M.D., Principal investigator, Department of Surgery, S:t Goran Hospital, Stockholm, Sweden.Eduard Jonas, M.D., Principal investigator, Department of Surgery, Danderyd Hospital, Stockholm, Sweden.Claes Rudberg, M.D., Principal investigator, Department of Surgery, Central Hospital, Vasteras, Sweden.Kalev Teder, M.D., Principal investigator, Department of Surgery, Central Hospital, Norrkoping, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280709
- Sponsor's protocol ID
- ELLA
- Status last verified
- Dec 2010
- First submitted
- 20 Jan 2006
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gozen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010 Nov;72(5):915-23. doi: 10.1016/j.gie.2010.07.036.
PubMed 21034892
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT00280709
- Acronym / sponsor ID
- ELLA
- Keywords
- Bile duct, Bile duct obstruction, Biliary stent, Metal stent, ERCP, Patency, Complication, Stent occlusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Jan 2006 (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.
The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)Covered metal stent |
| 2 | Active comparator | Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)Uncovered metal stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 20 years of age or older
- oral and written information given and informed consent obtained
- clinical data in accordance with malignant bile duct obstruction
- ultrasonography signs of extrahepatic malignant common bile duct obstruction
- typical radiological findings at ERCP of malignant common bile duct stenosis
Key exclusion criteria (9 listed)
- patients with active hepatitis or other hepatic diseases that may cause jaundice
- informed consent not obtained
- metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria)
- the patient is probably a candidate for surgical resection
- suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
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 |
|---|---|---|
| "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm | Device | 1, 2 |
Primary outcome
Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?
Time frame: 12 months after stent insertion
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 10 Aug 2011.
- Derived from this study: PubMed 21034892Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gozen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010 Nov;72(5):915-23. doi: 10.1016/j.gie.2010.07.036.
Related trials for Bile Duct Obstruction
Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
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.
Eric P Kullman, M.D. study chair
Department of Surgery, University Hostpital, Linkoping, Sweden.
Claes Soderlund, M.D. principal investigator
Department of Surgery, Sodersjukhuset, Stockholm, Sweden.
Bo Ohlin, M.D. principal investigator
Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent) in people with Bile Duct Obstruction and Pancreatic Cancer, run by University Hospital, Linkoeping at 1 site 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 8 inclusion and 9 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 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction? (time frame: 12 months after stent insertion). 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 NCT00280709, 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 10 Aug 2011.