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2016-10-18
2018-09-01
2018-10-01
120
NCT03063554
Weill Medical College of Cornell University
Weill Medical College of Cornell University
INTERVENTIONAL
EUS BD vs ERCP TP for Pancreatic Cancer
This Endoscopic Ultrasound guided Biliary Drainage (EUS-BD) vs. Endoscopic Retrograde Cholangiopancreatography (ERCP-TP) trial (BILPAL) is a randomized controlled multicenter trial that will provide evidence whether or not traditional ERCP biliary drainage is to be performed in patients with obstruction in bile duct due to unresectable pancreatic head or periampullary tumor.
Obstructive jaundice is the most common symptom in patients with periampullary cancer and cancer of the pancreatic head. For patients with unresectable tumors, palliation of malignant obstructive is traditionally achieved using endoscopic retrograde cholangiopancreatography (ERCP) with transpapillary (TP) stent placement. Data show that ERCP is equivalent to surgery with regards to relief of jaundice. Self-expandable metal stents (SEMS) offer prolonged palliation compared to large-bore (10Fr) plastic stents. However, it is believed that gastric outlet obstruction occurs more commonly in patients who have received SEMS for palliation of MOJ. In addition, ERCP is associated with adverse events including pancreatitis, post-sphincterotomy bleeding, and perforation. More recently endoscopic ultrasound (EUS)-guided biliary drainage has been described for biliary drainage in patients with malignant distal bile duct obstruction. Thus far it has been used as a rescue approach when traditional ERCP-guided transpapillary biliary drainage ERCP fails. TP failure can occur as a result of duodenal obstruction, failed cannulation, and failed wire access across the stricture. Potential advantages of EUS-guided biliary drainage include avoidance of pancreatitis and post-sphincterotomy bleeding. Additionally, it may result in a lower frequency of gastric outlet obstruction since the stent does not encroach upon the tumor. To compare the potential advantages of EUS-guided biliary drainage the investigators are conducting a multicenter, randomized trial comparing the EUS-guided drainage to traditional ERCP. This EUS-BD vs. ERCP-TP-trial (BILPAL) is a randomized controlled multicenter trial that will provide evidence whether or not traditional ERCP biliary drainage is to be performed in patients with obstruction in bile duct due to unresectable pancreatic head or periampullary tumor. This study will enroll 120 subjects; 60 subjects in each arm. Trial duration is about 1 year and involves 5-7 visits.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-02-16 | N/A | 2017-02-20 |
2017-02-20 | N/A | 2017-02-24 |
2017-02-24 | N/A | 2017-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Endoscopic Ultrasound Guided Biliary Drainage Endoscopic Ultrasound Guided biliary drainage with stent placement. EUS via either stomach or duodenum. | PROCEDURE: Endoscopic Ultrasound Guided Biliary Drainage
|
| PLACEBO_COMPARATOR: ERCP Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only. | PROCEDURE: ERCP
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Efficacy of Stent Patency | Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization | 6 months after randomization |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety evaluation: Assessment of number and frequency of procedure related adverse events within 1 month of the procedure | Assessment of number and frequency of procedure related adverse events within 1 month of the procedure | Within 1 month of procedure |
| Clinical Success | Resolution of jaundice due to obstruction in the bile duct | 1 month from procedure |
| Technical Success | Technical success is defined as successful stent insertion providing biliary drainage with confirmation of appropriate radiographic positioning | 1 month from procedure |
| Survival duration | Survival duration will be measured from time of diagnosis to death | 2 years from randomization |
| Serum bilirubin decrease | Duration to achieving at least 30% decrease in serum bilirubin or normalization of serum bilirubin level (≤1.2 mg/dL) | 1 month from procedure |
| Quality of Life | QOL will be measured via QLQ-C30 questionnaires completed by the subject at each follow up visit | 1 year from study enrollment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Michel Kahaleh, MD Phone Number: 646-962-4797 Email: mik9071@med.cornell.edu |
Study Contact Backup Name: Monica R Gaidhane, MPH Phone Number: 646-962-4796 Email: mog2012@med.cornell.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
