Pancreatic CancerNCT02238847
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
A study testing WallFlex™ Biliary RX Fully Covered/Uncovered Stent System in people with Pancreatic Cancer, run by Boston Scientific Corporation at 9 sites in 6 countries.
Trial summary
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy. 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?
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 24 Mar 2015to 10 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or older
- Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Suspicion of pancreatic adenocarcinoma
- Likely indicated for neoadjuvant treatment
- Distal biliary obstruction consistent with pancreatic cancer
- Location of distal biliary obstruction such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum
- Endoscopic and surgical treatment to be provided at the same institution
Who cannot join
- Benign biliary strictures
- Malignancy secondary to Intraductal Papillary Mucinous Neoplasm
- Surgically altered anatomy where ERCP is not possible
- Previous biliary drainage using a SEMS or multiple plastic stents
- Contraindications for endoscopic techniques
- Patients who are currently enrolled in another investigational trial that would directly interfere with the current study
- Pregnancy
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
United States4 sites
Indiana University Medical Center
Indianapolis, Indiana, 46202
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Virginia Mason Medical Center
Seattle, Washington, 98101
Canada1 site
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
Montreal, Quebec, H2X 0A9
About this study
Official title: Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.
- Conditions
- Pancreatic Cancer
- Being tested
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Keywords
- Pancreatic, Pancreatic Cancer, Preoperative Biliary Drainage, Neoadjuvant Therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemDevice
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
| Study group | Role | What they receive |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Active comparator | Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System Receives: Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
| WallFlex Biliary RX Uncovered Stent System | Active comparator | Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System Receives: Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.
Measured: From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)
Secondary outcomes (6)
Procedure-related or Stent-related Serious Adverse Events
Serious adverse events related to the stent placement procedure or to the stent
Measured: From stent placement procedure up to one year after stent placement procedure
Technical Success
Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.
Measured: During the Stent Placement Procedure
Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention
Measured: From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS
Number of Participants With Stent Migration
The number of participants with stent migration
Measured: At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS
Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure
The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.
Measured: At the time of curative intent surgery (CIS) (median 110 days to CIS)
For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.
Measured: From stent placement to one year after stent placement for participants not undergoing curative intent surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study start24 Mar 2015
- Primary completion21 Feb 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 Boston Scientific CorporationThe 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yousuke Nakai, MD, PhD, Principal investigator, Tokyo UniversityDong-Wan Seo, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238847
- Sponsor's protocol ID
- 90905950
- Other IDs
- E7034
- Status last verified
- Feb 2020
- First submitted
- 2 May 2014
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Seo DW, Sherman S, Dua KS, Slivka A, Roy A, Costamagna G, Deviere J, Peetermans J, Rousseau M, Nakai Y, Isayama H, Kozarek R; Biliary SEMS During Neoadjuvant Therapy Study Group. Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial. Gastrointest Endosc. 2019 Oct;90(4):602-612.e4. doi: 10.1016/j.gie.2019.06.032. Epub 2019 Jul 2.
PubMed 31276674
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02238847
- Acronym / sponsor ID
- 90905950
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic, Pancreatic Cancer, Preoperative Biliary Drainage, Neoadjuvant Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2015 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Active comparator | Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemPatients in this group will receive a fully covered study SEMS (self-expanding metal stent) Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System |
| WallFlex Biliary RX Uncovered Stent System | Active comparator | Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemPatients in this group will receive an uncovered study SEMS (self-expanding metal stent). Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or older
- Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Suspicion of pancreatic adenocarcinoma
- Likely indicated for neoadjuvant treatment
Key exclusion criteria (7 listed)
- Benign biliary strictures
- Malignancy secondary to Intraductal Papillary Mucinous Neoplasm
- Surgically altered anatomy where ERCP is not possible
- Previous biliary drainage using a SEMS or multiple plastic stents
- Contraindications for endoscopic techniques
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 |
|---|---|---|
| WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemReintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System | Device | WallFlex Biliary RX Fully Covered Stent System, WallFlex Biliary RX Uncovered Stent System |
Primary outcome
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
Time frame: From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)
Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.
6 secondary outcomes
Procedure-related or Stent-related Serious Adverse Events
Time frame: From stent placement procedure up to one year after stent placement procedure
Technical Success
Time frame: During the Stent Placement Procedure
Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
Time frame: From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS
Number of Participants With Stent Migration
Time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS
Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure
Time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS)
For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
Time frame: From stent placement to one year after stent placement for participants not undergoing curative intent surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31276674Seo DW, Sherman S, Dua KS, Slivka A, Roy A, Costamagna G, Deviere J, Peetermans J, Rousseau M, Nakai Y, Isayama H, Kozarek R; Biliary SEMS During Neoadjuvant Therapy Study Group. Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial. Gastrointest Endosc. 2019 Oct;90(4):602-612.e4. doi: 10.1016/j.gie.2019.06.032. Epub 2019 Jul 2.
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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.
Yousuke Nakai, MD, PhD principal investigator
Tokyo University
Dong-Wan Seo, MD principal investigator
Asan Medical Center
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WallFlex™ Biliary RX Fully Covered/Uncovered Stent System in people with Pancreatic Cancer, run by Boston Scientific Corporation at 9 sites in 6 countries.
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 7 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium, Canada, Italy, Japan and 1 more country. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms (time frame: From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)). 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 NCT02238847, 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 17 Feb 2020.