Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WallFlex Biliary RX Fully Covered Stent System<br>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<br>* Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System<br>|
| Active Comparator: WallFlex Biliary RX Uncovered Stent System<br>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<br>* Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic, Pancreatic Cancer, Preoperative Biliary Drainage, Neoadjuvant Therapy