Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
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| ClinicalTrials.gov Identifier: NCT01774019 |
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Recruitment Status :
Recruiting
First Posted : January 23, 2013
Last Update Posted : January 26, 2021
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Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
- Study Details
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Carcinoma | Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 294 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | February 20, 2013 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | March 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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)
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Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System |
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No Intervention: None (No Pre-Operative Biliary Drainage)
Patients in this group will not receive pre-operative biliary drainage with a study SEMS
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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 ]Count of Serious Adverse Events
Secondary Outcome Measures :
- Number of adverse events [ Time Frame: Procedure - 120 days ]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 ]Days until subject undergoes surgery
- Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques. [ Time Frame: Baseline to 4 weeks ]Details related to Curative Intent Surgery
- Amount of intraoperative blood loss and number of blood transfusions, duration of surgery [ Time Frame: At time of surgery ]Intraoperative blood loss in ml, count of transfusions and time from start to finish of surgery
- Biliary obstructive symptoms assessment [ Time Frame: Baseline - 120 days ]Record of symptoms associated with biliary obstruction
- Improvement of liver function test (LFT) levels as relative to baseline [ Time Frame: Week 2 - 120 days ]Laboratory tests for liver function
- Stent placement success [ Time Frame: Procedure ]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. ]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 ]Count and timing of biliary re-interventions
- Number of hospital and ICU admissions [ Time Frame: Procedure - 120 days ]Count of admissions to hospital and ICU
- Duration of hospital and ICU admissions [ Time Frame: Procedure - 120 days ]Length of stay in hospital and ICU
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774019
Contacts
| Contact: Andrea Burbage | 508-683-4387 | andrea.burbage@bsci.com | |
| Contact: Huma Preston | 508-683-4813 | huma.preston@bsci.com |
Locations
| United States, California | |
| Standford University Medical Center | Completed |
| Stanford, California, United States, 94305 | |
| United States, Indiana | |
| Indiana University Medical Center | Withdrawn |
| Indianapolis, Indiana, United States, 46202 | |
| Australia, New South Wales | |
| Westmead Hospital | Completed |
| Westmead, New South Wales, Australia, 2145 | |
| Belgium | |
| ULB Erasme Hospital | Recruiting |
| Brussels, Belgium, 1070 | |
| Contact: Mia Persoons +32 2 555 3016 Mia.Persoons@erasme.ulb.ac.be | |
| Principal Investigator: Jacques Devière, MD | |
| Canada, Quebec | |
| Centre hospitalier de l Université de Montréal | Withdrawn |
| Montreal, Quebec, Canada, H2X 3J4 | |
| China | |
| Beijing Friendship Hospital | Recruiting |
| Beijing, China | |
| Contact: Hongmin Yu hongmin.yu@tigermedgrp.com | |
| Principal Investigator: Peng Li, MD | |
| Xijing Hospital of Digestive Diseases Fourth Military Medical University | Recruiting |
| Xi'an, China | |
| Contact: Huan Hou huan.hou@tigermedgrp.com | |
| Principal Investigator: Kaishan Tao, MD | |
| France | |
| Hopital Edouard Herriot | Completed |
| Lyon, France, 69437 | |
| Hong Kong | |
| Queen Elizabeth Hospital | Recruiting |
| Kowloon, Hong Kong | |
| Contact: Bing Yee Suen suenbingyee@surgery.cuhk.edu.hk | |
| Principal Investigator: Nam-Hung Chia, MD | |
| Prince of Wales Hospital, the Chinese University of Hong Kong | Recruiting |
| Sha Tin, Hong Kong | |
| Contact: Bing Yee Suen suenbingyee@surgery.cuhk.edu.hk | |
| Principal Investigator: James Lau, MD | |
| India | |
| Asian Institute of Gastroenterology | Recruiting |
| Hyderabad, India, 500 082 | |
| Contact: Sana Fatima sana.aigindia@gmail.com | |
| Principal Investigator: Nageshwar Reddy, MD | |
| Italy | |
| Fondazione Policlinico Universitario Agostino Gemelli | Recruiting |
| Rome, Italy, 00168 | |
| Contact: Carolina Gualtieri +390630156580 carolina.gualtieri@policlinicogemelli.it | |
| Contact: Andrea Tringali, MD andrea.tringali@unicatt.it | |
| Principal Investigator: Guido Costamagna, MD | |
| Japan | |
| Tokyo Medical University | Completed |
| Tokyo, Japan, 160-0023 | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Principal Investigator: | Guido Costamagna, MD | Fondazione Policlinico Universitario Agostino Gemelli |
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01774019 |
| Other Study ID Numbers: |
90914721 E7059 ( Other Identifier: Boston Scientific ) |
| First Posted: | January 23, 2013 Key Record Dates |
| Last Update Posted: | January 26, 2021 |
| Last Verified: | January 2021 |
Keywords provided by Boston Scientific Corporation:
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Pancreatic Periampullary Cancer Preoperative Biliary Drainage Resectable |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |