Pancreatic CarcinomaNCT01774019
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
A study testing WallFlex™ Biliary RX Fully Covered/Uncovered Stent System in people with Pancreatic Carcinoma, run by Boston Scientific Corporation at 11 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 11 sitesin 9 countries
- Study dates
- 20 Feb 2013to 13 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
- Biliary obstructive symptoms or signs
- Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
- Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
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- Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum
- Patients deemed as resectable by pancreatic protocol CT or MRI
- Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion
- Surgery intent within 4 weeks
- Endoscopic and surgical treatment to be provided by same team
Who cannot join
- Biliary strictures caused by confirmed benign tumors
- Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
- Surgically altered biliary tract anatomy, not including prior cholecystectomy
- Neoadjuvant chemotherapy for current malignancy
- Palliative indication due to reasons other than surgical candidate status
- Previous biliary drainage by ERCP/PTC
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- Patients for whom endoscopic techniques are contraindicated
- Participation in another investigational trial within 90 days
- Pregnancy
Trial locations and contacts
11 sites in 9 countries.
11 sites in 9 countries
China2 sites
Beijing Friendship Hospital
Beijing
Xijing Hospital of Digestive Diseases Fourth Military Medical University
Xi'an
Hong Kong2 sites
Queen Elizabeth Hospital
Kowloon
Prince of Wales Hospital, the Chinese University of Hong Kong
Shatin
United States1 site
Standford University Medical Center
Stanford, California, 94305
About this study
Official title: Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
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.
- Conditions
- Pancreatic Carcinoma
- Being tested
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- Keywords
- Pancreatic, Periampullary Cancer, Preoperative Biliary Drainage, Resectable
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
| None (No Pre-Operative Biliary Drainage) | No intervention | Patients in this group will not receive pre-operative biliary drainage with a study SEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 to 150 days
Secondary outcomes (4)
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)
Measured: Procedure
Number of Patients With Biliary Re-interventions
Count of patients with biliary interventions after baseline
Measured: 120 to 150 days
Success Rate of Curative Intent Surgery
This is the number of patients that had successful resection
Measured: 4 weeks
All-cause Mortality
Mortality which occurs within 150 days of baseline
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study start20 Feb 2013
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guido Costamagna, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774019
- Sponsor's protocol ID
- 90914721
- Other IDs
- E7059
- Status last verified
- Apr 2023
- First submitted
- 2 Oct 2012
- Last updated
- 10 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 41951900
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
- ClinicalTrials.gov ID
- NCT01774019
- Acronym / sponsor ID
- 90914721
- Conditions
- Pancreatic Carcinoma
- Keywords
- Pancreatic, Periampullary Cancer, Preoperative Biliary Drainage, Resectable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2013 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 10 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Active comparator | Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 or older
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
- Biliary obstructive symptoms or signs
- Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
Key exclusion criteria (9 listed)
- Biliary strictures caused by confirmed benign tumors
- Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
- Surgically altered biliary tract anatomy, not including prior cholecystectomy
- Neoadjuvant chemotherapy for current malignancy
- Palliative indication due to reasons other than surgical candidate status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Device | WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
Primary outcome
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
Time frame: 120 to 150 days
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.
4 secondary outcomes
Stent Placement Success
Time frame: Procedure
Number of Patients With Biliary Re-interventions
Time frame: 120 to 150 days
Success Rate of Curative Intent Surgery
Time frame: 4 weeks
All-cause Mortality
Time frame: 150 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41951900Costamagna 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Costamagna, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli
11 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WallFlex™ Biliary RX Fully Covered/Uncovered Stent System in people with Pancreatic Carcinoma, run by Boston Scientific Corporation at 11 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, Hong Kong, United States, Australia, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 120 to 150 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.