Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
This study is currently recruiting participants.
Verified March 2013 by Boston Scientific Corporation
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01774019
First received: October 2, 2012
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) improves overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Carcinoma |
Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- 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 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of adverse events [ Time Frame: Procedure - 120 days ] [ Designated as safety issue: Yes ]Adverse events will be assessed in terms of rate, severity, seriousness, relatedness to stent or endoscopic or surgical procedure, impact on time of surgery, length of hospitalization and ICU stay.
- Time to surgery [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
- Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques. [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
- Amount of intraoperative blood loss and number of blood transfusions, duration of surgery [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
- Biliary obstructive symptoms assessment [ Time Frame: Baseline - 120 days ] [ Designated as safety issue: No ]
- Improvement of liver function test (LFT) levels as relative to baseline [ Time Frame: Week 2 - 120 days ] [ Designated as safety issue: No ]
- Stent placement success [ Time Frame: Procedure ] [ Designated as safety issue: No ]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)
- Stent removal success [ Time Frame: At time of surgery or prior to surgery if re-intervention is needed. ] [ Designated as safety issue: No ]Stent removal success: successful SEMS removal, either en bloc at time of surgery or endoscopically prior to surgery without stent removal related SAEs (For patients who are randomized to biliary drainage with a metal stent)
- Number, type, reason, and timing of biliary re-interventions [ Time Frame: Baseline - 120 days ] [ Designated as safety issue: No ]
- Number of hospital and ICU admissions [ Time Frame: Procedure - 120 days ] [ Designated as safety issue: No ]
- Duration of hospital and ICU admissions [ Time Frame: Procedure - 120 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 294 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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)
|
Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
|
No Intervention: None (No Pre-Operative Biliary Drainage)
Patients in this group will not receive pre-operative biliary drainage with a study SEMS
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- Patients for whom endoscopic techniques are contraindicated
- Participation in another investigational trial within 90 days
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774019
Contacts
| Contact: Lina Ginnetti | 508-683-4512 | lina.ginnetti@bsci.com |
| Contact: Nguyet Nguyen | 508-683-4065 | nguyet.nguyen2@bsci.com |
Locations
| Australia, New South Wales | |
| Westmead Hospital | Not yet recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Rebecca Sonson +61 411 533 126 bec2153@gmail.com | |
| Principal Investigator: Michael Bourke, MD | |
| Belgium | |
| ULB Erasme Hospital | Recruiting |
| Brussels, Belgium, 1070 | |
| Contact: Mona Hammam 32 25 55 36 22 Mona.Hammam@erasme.ulb.ac.be | |
| Principal Investigator: Jacques Devière, MD | |
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital | Not yet recruiting |
| Montreal, Quebec, Canada, H2X 3J4 | |
| Contact: Josée Gagnon 514-890-8000 ext 35806 j.gagnon.chum@ssss.gouv.qc.ca | |
| Principal Investigator: André Roy, MD | |
| China | |
| Prince of Wales Hospital, the Chinese University of Hong Kong | Not yet recruiting |
| Hong Kong, China | |
| Contact: Kim Au kimau@surgery.cuhk.edu.hk | |
| Principal Investigator: James Lau, MD | |
| France | |
| Hopital Edouard Herriot | Not yet recruiting |
| Lyon, France, 69437 | |
| Contact: Hadjira Ouadfel +33-610133675 hadjira.ouadfel@chu-lyon.fr | |
| Principal Investigator: Thierry Ponchon, MD | |
| India | |
| Asian Institute of Gastroenterology | Recruiting |
| Hyderabad, India, 500 082 | |
| Contact: Nalini Durga nalinidurgaaig@gmail.com | |
| Principal Investigator: Nageshwar Reddy, MD | |
| Italy | |
| Università Cattolica del Sacro Cuore Policlinico A. Gemelli | Recruiting |
| Rome, Italy, 00168 | |
| Contact: Carolina Gualtieri +39 (06) 35511515 c.gualtieri@eetc.it | |
| Principal Investigator: Guido Costamagna, MD | |
| Japan | |
| Tokyo Medical University | Not yet recruiting |
| Tokyo, Japan, 160-0023 | |
| Contact: Takao Itoi, MD 81-3-33426111 itoi@tokyo-med.ac.jp | |
| Principal Investigator: Takao Itoi, MD | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Principal Investigator: | Guido Costamagna, MD | Universita Cattolica del Sacro Cuore |
More Information
No publications provided
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01774019 History of Changes |
| Other Study ID Numbers: | CDM00047339, E7059 |
| Study First Received: | October 2, 2012 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hong Kong: Department of Health India: Ministry of Health Italy: Ministry of Health Japan: Institutional Review Board |
Keywords provided by Boston Scientific Corporation:
|
Pancreatic Periampullary Cancer Preoperative Biliary Drainage Resectable |
Additional relevant MeSH terms:
|
Carcinoma Pancreatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms |
Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013