Pancreatic Cancer
Conditions
Keywords
Pancreatic, Pancreatic Cancer, Preoperative Biliary Drainage, Neoadjuvant Therapy
Brief 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.
Interventions
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | During the Stent Placement Procedure | 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. |
| 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 | The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention |
| Procedure-related or Stent-related Serious Adverse Events | From stent placement procedure up to one year after stent placement procedure | Serious adverse events related to the stent placement procedure or to the stent |
| Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure | At the time of curative intent surgery (CIS) (median 110 days to CIS) | The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure. |
| For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement | From stent placement to one year after stent placement for participants not undergoing curative intent surgery | For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement. |
| 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 | The number of participants with stent migration |
Countries
Belgium, Canada, Italy, Japan, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System | 59 |
| 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
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System | 60 |
| Total | 119 |
Baseline characteristics
| Characteristic | WallFlex Biliary RX Uncovered Stent System | Total | WallFlex Biliary RX Fully Covered Stent System |
|---|---|---|---|
| Age, Continuous | 65.0 years | 65 years | 67.0 years |
| Gallbladder in Situ | 42 Participants | 85 Participants | 43 Participants |
| Karnofsky Score (overall health status) | 80.0 units on a scale | 90 units on a scale | 90.0 units on a scale |
| Number of participants not undergoing curative intent surgery&followed to 1year post-stent placement | 32 Participants | 62 Participants | 30 Participants |
| Number of participants who underwent curative intent surgery | 27 Participants | 51 Participants | 24 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 27 Participants | 53 Participants | 26 Participants |
| Sex: Female, Male Male | 33 Participants | 66 Participants | 33 Participants |
| Tumor Size | 2.9 cm STANDARD_DEVIATION 50.9 | 3.0 cm STANDARD_DEVIATION 1.2 | 3.1 cm STANDARD_DEVIATION 1.4 |
| Tumor Stage IA - T1 N0 M0 | 3 Participants | 10 Participants | 7 Participants |
| Tumor Stage IB - T2 N0 M0 | 6 Participants | 11 Participants | 5 Participants |
| Tumor Stage IIA - T3 N0 M0 | 24 Participants | 43 Participants | 19 Participants |
| Tumor Stage IIB - T1 N1 M0; T2 N1 M0; T3 N1 M0 | 15 Participants | 30 Participants | 15 Participants |
| Tumor Stage III - T4 Any N M0 | 5 Participants | 10 Participants | 5 Participants |
| Tumor Stage Unknown | 7 Participants | 15 Participants | 8 Participants |
| Weight | 78.4 kg | 78 kg | 77.7 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 59 | 25 / 60 |
| other Total, other adverse events | 0 / 59 | 0 / 60 |
| serious Total, serious adverse events | 14 / 59 | 12 / 60 |
Outcome results
Primary
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.
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)
Population: Participant was eligible for primary endpoint analysis if participant did not undergo biliary reintervention from time of SEMS placement to CIS, or from time of SEMS placement to one year after SEMS placement (for participants not undergoing CIS).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms | 39 Participants |
| WallFlex Biliary RX Uncovered Stent System | Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms | 43 Participants |
p-value: <0.01Exact Non-inferiority
Secondary
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
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
Population: Of 59 participants in the Fully Covered arm, neoadjuvant therapy information was only provided for 55 participants. Of 60 participants in the Uncovered arm, neoadjuvant therapy information was only provided for 52 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention | 53 Participants |
| WallFlex Biliary RX Uncovered Stent System | Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention | 51 Participants |
Secondary
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.
Time frame: From stent placement to one year after stent placement for participants not undergoing curative intent surgery
Population: 30 participants in the Fully Covered arm did not undergo curative intent surgery and were followed for one year. 32 participants in the Uncovered arm did not undergo curative intent surgery and were followed for one year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement | 19 Participants |
| WallFlex Biliary RX Uncovered Stent System | For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement | 21 Participants |
Secondary
Number of Participants With Stent Migration
The 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Number of Participants With Stent Migration | 5 Participants |
| WallFlex Biliary RX Uncovered Stent System | Number of Participants With Stent Migration | 0 Participants |
Secondary
Procedure-related or Stent-related Serious Adverse Events
Serious adverse events related to the stent placement procedure or to the stent
Time frame: From stent placement procedure up to one year after stent placement procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Procedure-related or Stent-related Serious Adverse Events | 14 Participants |
| WallFlex Biliary RX Uncovered Stent System | Procedure-related or Stent-related Serious Adverse Events | 12 Participants |
p-value: 0.66Fisher Exact
Secondary
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.
Time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS)
Population: Of 59 Participants in Fully Covered Arm, 24 underwent Curative Intent Surgery. Of 60 Participants in Uncovered Arm, 27 underwent Curative Intent Surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure | 3 Participants |
| WallFlex Biliary RX Uncovered Stent System | Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure | 4 Participants |
Secondary
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.
Time frame: During the Stent Placement Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Technical Success | 58 Participants |
| WallFlex Biliary RX Uncovered Stent System | Technical Success | 60 Participants |
Post Hoc
Mortality at One Year After Randomization
The mortality at one year after randomization.
Time frame: From randomization to one year after randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Mortality at One Year After Randomization | 21 Participants |
| WallFlex Biliary RX Uncovered Stent System | Mortality at One Year After Randomization | 25 Participants |
Post Hoc
Number of Participants With Acute Cholecystitis
The number of participants with acute cholecystitis
Time frame: From stent placement up to curative intent surgery (CIS) (median 110 days to CIS), or from stent placement up to one year post stent placement for participants not undergoing CIS
Population: 43/59 participants in Fully Covered Arm and 42/60 participants in Uncovered Arm had gallbladder in situ. Therefore, Acute Cholecystitis only analyzed in 43 participants in Fully Covered Arm and 42 participants in Uncovered Arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Number of Participants With Acute Cholecystitis | 4 Participants |
| WallFlex Biliary RX Uncovered Stent System | Number of Participants With Acute Cholecystitis | 2 Participants |
Post Hoc
Number of Participants With Tumor Ingrowth
The number of participants with tumor ingrowth at any point during stent indwell.
Time frame: Measured at any point during stent indwell - until curative intent surgery (CIS) (median 110 days to CIS) or one year post stent placement (for participants not underoing CIS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | Number of Participants With Tumor Ingrowth | 0 Participants |
| WallFlex Biliary RX Uncovered Stent System | Number of Participants With Tumor Ingrowth | 10 Participants |