Pancreatic CancerNCT03350763
Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
A study testing Tannenbaum 10 Fr biliary stent and Self-expandable metallic biliary stent in people with Pancreatic Cancer, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Tannenbaum 10 Fr biliary stent and Self-expandable metallic biliary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 18 Nov 2017to Dec 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable tumor of the head of the pancreas
- Elevated serum bilirubin levels
- Radiologically visible dilatation of the biliary system
Who cannot join
- Distant metastasis
- Inoperable tumor or other reason, why the patient is unfit for surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded.
This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.
- Conditions
- Pancreatic Cancer
- Being tested
- Tannenbaum 10 Fr biliary stent, Self-expandable metallic biliary stent
- Keywords
- Pancreatic Cancer, Biliary decompression
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tannenbaum 10 Fr biliary stentDevice
Tannenbaum 10 Fr biliary stent
Self-expandable metallic biliary stentDevice
ie WallFlex biliary RX
| Study group | Role | What they receive |
|---|---|---|
| Plastic biliary stent | Experimental | A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression Receives: Device: Tannenbaum 10 Fr biliary stent |
| Self-expandable metallic biliary stent | Experimental | A self-expandable metallic biliary stent is used to achieve biliary decompression Receives: Device: Self-expandable metallic biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.
Measured: Evaluation at the day of pancreatic surgery
Secondary outcomes (1)
Other complications related to preoperative biliary decompression, and post-surgical complications
Measured: Complication emerged within 120 days from pancreaticoduodenectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start18 Nov 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Investigators busy with other projects at the moment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leena Kylanpaa, Helsinki University Central Hospital
- Investigators
- Leena Kylänpää, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350763
- Sponsor's protocol ID
- HUS/2470/2017
- Status last verified
- May 2021
- First submitted
- 18 Nov 2017
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4.
PubMed 21373939Haapamaki C, Seppanen H, Udd M, Juuti A, Halttunen J, Kiviluoto T, Siren J, Mustonen H, Kylanpaa L. Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent. Scand J Surg. 2015 Jun;104(2):79-85. doi: 10.1177/1457496914543975. Epub 2014 Jul 15.
PubMed 25028410Velanovich V, Kheibek T, Khan M. Relationship of postoperative complications from preoperative biliary stents after pancreaticoduodenectomy. A new cohort analysis and meta-analysis of modern studies. JOP. 2009 Jan 8;10(1):24-9.
PubMed 19129611
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
- ClinicalTrials.gov ID
- NCT03350763
- Acronym / sponsor ID
- HUS/2470/2017
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Biliary decompression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigators busy with other projects at the moment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Nov 2017 (actual)
- 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.
This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded.
This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic biliary stent | Experimental | Device: Tannenbaum 10 Fr biliary stentA plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression |
| Self-expandable metallic biliary stent | Experimental | Device: Self-expandable metallic biliary stentA self-expandable metallic biliary stent is used to achieve biliary decompression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resectable tumor of the head of the pancreas
- Elevated serum bilirubin levels
- Radiologically visible dilatation of the biliary system
Key exclusion criteria (2 listed)
- Distant metastasis
- Inoperable tumor or other reason, why the patient is unfit for surgery
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 |
|---|---|---|
| Tannenbaum 10 Fr biliary stentTannenbaum 10 Fr biliary stent | Device | Plastic biliary stent |
| Self-expandable metallic biliary stentie WallFlex biliary RX | Device | Self-expandable metallic biliary stent |
Primary outcome
Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.
Time frame: Evaluation at the day of pancreatic surgery
1 secondary outcome
Other complications related to preoperative biliary decompression, and post-surgical complications
Time frame: Complication emerged within 120 days from pancreaticoduodenectomy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Background: PubMed 21373939Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4.
- Background: PubMed 25028410Haapamaki C, Seppanen H, Udd M, Juuti A, Halttunen J, Kiviluoto T, Siren J, Mustonen H, Kylanpaa L. Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent. Scand J Surg. 2015 Jun;104(2):79-85. doi: 10.1177/1457496914543975. Epub 2014 Jul 15.
- Background: PubMed 19129611Velanovich V, Kheibek T, Khan M. Relationship of postoperative complications from preoperative biliary stents after pancreaticoduodenectomy. A new cohort analysis and meta-analysis of modern studies. JOP. 2009 Jan 8;10(1):24-9.
- Individual participant dataSharing planned: No
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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.
Leena Kylänpää, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tannenbaum 10 Fr biliary stent and Self-expandable metallic biliary stent in people with Pancreatic Cancer, run by Helsinki University Central Hospital at 1 site in Finland.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 May 2021. 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 Finland. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Stent failure rate, and need for re-procedure before pancreaticoduodenectomy. (time frame: Evaluation at the day of pancreatic surgery). 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 NCT03350763, which also lists 3 linked publications.
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 19 May 2021.