Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| E7034 | Other Identifier | Boston Scientific |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Device | Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System |
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yousuke Nakai, MD, PhD | Tokyo University | Principal Investigator |
| Dong-Wan Seo, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States | ||
| University of Pittsburgh Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31276674 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | 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) |
|
Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Cholecystitis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lina Ginnetti, Clinical Endoscopy Director | Boston Scientific Corporation | 508-683-4512 | lina.ginnetti@bsci.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2015 | Jul 17, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2015 | Jul 17, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| CUB Hopital Erasme | Brussels | 1070 | Belgium |
| Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital | Montreal | Quebec | H2X 0A9 | Canada |
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | 00168 | Italy |
| Tokyo University Hospital | Tokyo | 113-8655 | Japan |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| Gallbladder in Situ | A count of participants with no prior history of cholecystectomy (gallbladder still in place). | Count of Participants | Participants |
|
| Karnofsky Score (overall health status) | 100 Normal no complaints nor evidence of disease;90 Normal activity, minor signs/symptoms of disease;80 Normal activity w/effort, some sign/symptom of disease;70 Cares for self, unable to carry on normal activity/do active work;60 Requires occasional assistance, able to care for most personal needs;50 Requires considerable assistance & frequent medical care;40 Disabled, requires special care/assistance;30 Severely disabled, hospitalization indicated, death not imminent;20 Very sick, hospitalization & active support treatment necessary;10 Moribund, fatal processes progress rapidly;0 Dead | Median | Inter-Quartile Range | units on a scale |
|
| Tumor Size | Mean | Standard Deviation | cm |
|
| Tumor Stage | Tumor, Node, Metastasis Cancer Staging System: Primary Tumor (T)1-4: Tumor size and extent; higher number indicates larger tumor and/or spread to nearby tissues Regional Lymph Node (N)0-3: N0 no regional lymph node involvement; 1-3 indicates number of regional lymph nodes involved and extent of involvement (higher number is more lymph node involvement) Distant Metastasis (M)0: No distant metastases | Count of Participants | Participants |
|
| Number of participants who underwent curative intent surgery | Count of Participants | Participants |
|
| Number of participants not undergoing curative intent surgery&followed to 1year post-stent placement | Count of Participants | Participants |
|
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
| OG001 | 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 |
|
|
|
| Secondary | Procedure-related or Stent-related Serious Adverse Events | Serious adverse events related to the stent placement procedure or to the stent | Posted | Count of Participants | Participants | From stent placement procedure up to one year after stent placement procedure |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | During the Stent Placement Procedure |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | Number of Participants With Stent Migration | The number of participants with stent migration | Posted | Count of Participants | Participants | At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS |
|
|
|
| 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. | Of 59 Participants in Fully Covered Arm, 24 underwent Curative Intent Surgery. Of 60 Participants in Uncovered Arm, 27 underwent Curative Intent Surgery. | Posted | Count of Participants | Participants | At the time of curative intent surgery (CIS) (median 110 days to CIS) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | From stent placement to one year after stent placement for participants not undergoing curative intent surgery |
|
|
|
| Post-Hoc | Number of Participants With Tumor Ingrowth | The number of participants with tumor ingrowth at any point during stent indwell. | Posted | Count of Participants | Participants | 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) |
|
|
|
| Post-Hoc | Number of Participants With Acute Cholecystitis | The number of participants with acute cholecystitis | 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. | Posted | Count of Participants | Participants | 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 |
|
|
|
| Post-Hoc | Mortality at One Year After Randomization | The mortality at one year after randomization. | Posted | Count of Participants | Participants | From randomization to one year after randomization |
|
|
|
| 21 |
| 59 |
| 14 |
| 59 |
| 0 |
| 59 |
| EG001 | 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 | 25 | 60 | 12 | 60 | 0 | 60 |
| Acute Pancreatitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| CBD Obstruction or Abnormal LFTs | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Liver Abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| IIA - T3 N0 M0 |
|
| IIB - T1 N1 M0; T2 N1 M0; T3 N1 M0 |
|
| III - T4 Any N M0 |
|
| Unknown |
|