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| ID | Type | Description | Link |
|---|---|---|---|
| E7059 | Other Identifier | Boston Scientific |
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The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Active Comparator | Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) |
|
| None (No Pre-Operative Biliary Drainage) | No Intervention | Patients in this group will not receive pre-operative biliary drainage with a study SEMS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last | The primary end point was all serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later. | 120 to 150 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Placement Success | Stent placement success: ability to deploy the stent in satisfactory position across the stricture (For patients who are randomized to biliary drainage with a metal stent) | Procedure |
| Number of Patients With Biliary Re-interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Costamagna, MD | Fondazione Policlinico Universitario Agostino Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Standford University Medical Center | Stanford | California | 94305 | United States | ||
| Westmead Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41951900 | Derived | Costamagna G, Reddy DN, Chia NH, Itoi T, Deviere J, Lee KF, Rao GV, Alfieri S, Lo I, Kasuya K, Closset J, Carr-Locke DL, Chandwani R, Peetermans J, Rousseau M, Lau J. Preoperative Biliary Drainage with Metal Stent Versus Early Surgery in Patients with Pancreatic Cancer: A Randomized Clinical Trial. Ann Surg Oncol. 2026 Jul;33(7):6801-6811. doi: 10.1245/s10434-026-19546-9. Epub 2026 Apr 8. |
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Of the 765 participants assessed for eligibility, 284 met criteria and were randomized.
Study participants were screened by site investigators at 11 academic medical centers globally between February 2013 and August 2021.
The first participant was enrolled in February 2013 and the last participant was enrolled in August 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
| FG001 | None (No Pre-Operative Biliary Drainage) | Patients in this group will not receive pre-operative biliary drainage with a study SEMS |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
| BG001 | None (No Pre-Operative Biliary Drainage) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last | The primary end point was all serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later. | Posted | Count of Participants | Participants | 120 to 150 days |
|
All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
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| 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/Uncovered Stent System | Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Burbage | Boston Scientific | 15086834387 | Andrea.Burbage@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2014 | Dec 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2012 | Dec 7, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Count of patients with biliary interventions after baseline |
| 120 to 150 days |
| Success Rate of Curative Intent Surgery | This is the number of patients that had successful resection | 4 weeks |
| All-cause Mortality | Mortality which occurs within 150 days of baseline | 150 days |
| Westmead |
| New South Wales |
| 2145 |
| Australia |
| ULB Erasme Hospital | Brussels | 1070 | Belgium |
| Beijing Friendship Hospital | Beijing | China |
| Xijing Hospital of Digestive Diseases Fourth Military Medical University | Xi'an | China |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| Queen Elizabeth Hospital | Kowloon | Hong Kong |
| Prince of Wales Hospital, the Chinese University of Hong Kong | Shatin | Hong Kong |
| Asian Institute of Gastroenterology | Hyderabad | 500 082 | India |
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | 00168 | Italy |
| Tokyo Medical University | Tokyo | 160-0023 | Japan |
| Surgery delayed > 120 days |
|
| Patient refused surgery |
|
| Unable to implant study device |
|
| Lost to Follow-up |
|
Patients in this group will not receive pre-operative biliary drainage with a study SEMS |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Mean | Standard Deviation | units on a scale |
|
| Total serum bilirubin | Mean | Standard Deviation | mg/dl |
|
| Tumor location on imaging Head | Count of Participants | Participants |
|
| Tumor location on imaging Ampullary | Count of Participants | Participants |
|
| Tumor location on imaging distal | Count of Participants | Participants |
|
| Tumor location on imaging Uncinate process | Count of Participants | Participants |
|
| Tumor location on imaging Isthmus | Count of Participants | Participants |
|
| Tumor location on imaging tail | Count of Participants | Participants |
|
| Tumor location on imaging Duodenum | Count of Participants | Participants |
|
Patients in this group will not receive pre-operative biliary drainage with a study SEMS |
|
|
| Secondary | Stent Placement Success | Stent placement success: ability to deploy the stent in satisfactory position across the stricture (For patients who are randomized to biliary drainage with a metal stent) | 3 patients in the WallFlex Biliary RX Fully Covered/Uncovered Stent arm had no stent placed. Patients in the no drainage arm are not intended to have a stent placement per protocol. | Posted | Count of Participants | Participants | Procedure |
|
|
|
| Secondary | Number of Patients With Biliary Re-interventions | Count of patients with biliary interventions after baseline | Posted | Count of Participants | Participants | 120 to 150 days |
|
|
|
| Secondary | Success Rate of Curative Intent Surgery | This is the number of patients that had successful resection | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | All-cause Mortality | Mortality which occurs within 150 days of baseline | Posted | Count of Participants | Participants | 150 days |
|
|
|
| 11 |
| 144 |
| 40 |
| 144 |
| 0 |
| 144 |
| EG001 | None (No Pre-Operative Biliary Drainage) | Patients in this group will not receive pre-operative biliary drainage with a study SEMS | 11 | 140 | 36 | 140 | 0 | 140 |
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Hemorrhage after ERCP | Vascular disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Biliary obstruction | Investigations | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Left leg swelling | General disorders | Systematic Assessment |
|
| Persistent jaundice | Hepatobiliary disorders | Systematic Assessment |
|
| Respiratory infection | Infections and infestations | Systematic Assessment |
|
| Septic arthritis | Infections and infestations | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Subdural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hemorrhage after CIS | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Intra-abdominal abscess | Infections and infestations | Systematic Assessment |
|
| Pancreaticojejunostomy leakage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Biliary leakage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Delayed gastric emptying | Gastrointestinal disorders | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Diabetes | Metabolism and nutrition disorders | Systematic Assessment |
|
| Gastrojejunostomy or duodenojejunostomy leakage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hemorrhage after ERCP | Vascular disorders | Systematic Assessment |
|
| Hepatic artery thrombosis | Hepatobiliary disorders | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypovolemia | Vascular disorders | Systematic Assessment |
|
| Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreaticogastrostomy leakage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | Systematic Assessment |
|
| Refractory shock | Vascular disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Right hemiplegia | Nervous system disorders | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |