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2015-03-24
2018-02-21
2018-04-10
119
NCT02238847
Boston Scientific Corporation
Boston Scientific Corporation
INTERVENTIONAL
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-05-02 | 2019-07-25 | 2020-02-14 |
2014-09-10 | 2020-02-14 | 2020-02-17 |
2014-09-12 | 2020-02-17 | 2020-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: WallFlex Biliary RX Fully Covered Stent System 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 | DEVICE: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
|
| ACTIVE_COMPARATOR: WallFlex Biliary RX Uncovered Stent System 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 | DEVICE: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Procedure-related or Stent-related Serious Adverse Events | Serious adverse events related to the stent placement procedure or to the stent | 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. | 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 | 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 | 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. | 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. | From stent placement to one year after stent placement for participants not undergoing curative intent surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
