Pancreatic CancerBILPALNCT03063554
EUS BD vs ERCP TP for Pancreatic Cancer
A study testing Endoscopic Ultrasound Guided Biliary Drainage and ERCP in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Adenocarcinoma, Biliary Tract Neoplasms
- What is being tested?
- Endoscopic Ultrasound Guided Biliary Drainage and ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2016to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 90 years old
- Clinically indicated for biliary endoscopic drainage with Endoscopic Ultrasound guidance or ERCP
- CT scan has demonstrated a lesion in the pancreatic head area with metastases and/ or local tumor ingrowth preventing resection.
- CT with evidence of distant metastases or local tumor ingrowth into portal or mesenteric vessels (as defined by the tumor surrounding the vessel for at least 180 degrees of the circumference)
- A serum bilirubin level of > 2.5mg/dL at randomization
- Deemed surgically unresectable
- Consents to participation in the randomized controlled trial
Who cannot join
- > 90 years
- Severe comorbidity (Karnofsky <50%)
- Any prior successful previous biliary drainage including ERCP and stenting, percutaneous biliary and surgical,
- Prior surgically altered pancreaticobiliary or gastroduodenal anatomy.
- Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
- Currently participating in another device trial that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Michel Kahaleh, MD, 646-962-4797, mik9071@med.cornell.edu
Monica R Gaidhane, MPH, 646-962-4796 ext. Gaidhane, mog2012@med.cornell.edu
About this study
Official title: Endoscopic Ultrasound-Guided Biliary Drainage (EUS-BD) Compared to Standard Transpapillary Biliary Drainage (ERCP-TP) for Palliation of Jaundice in Unresectable Cancer of the Head of the Pancreas (BILPAL TRIAL)
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.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma, Biliary Tract Neoplasms, Biliary Duct Obstruction, Unresectable Pancreatic Cancer, Periampullary Cancer
- Being tested
- Endoscopic Ultrasound Guided Biliary Drainage, ERCP
- Keywords
- Endoscopy, Pancreatic Cancer, Bile duct, Periampullary, ERCP, Biliary drainage, Biliary obstruction, EUSBD, TEUS, EUS, Endoscopic Ultrasound
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound Guided Biliary DrainageProcedure or surgery
Also called EUSBD
Endoscopic Ultrasound Guided biliary drainage with stent placement;
ERCPProcedure or surgery
Also called ERCP-TP
Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Ultrasound Guided Biliary Drainage | Active comparator | Endoscopic Ultrasound Guided biliary drainage with stent placement. EUS via either stomach or duodenum. Receives: Procedure: Endoscopic Ultrasound Guided Biliary Drainage |
| ERCP | Placebo comparator | Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only. Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Stent Patency
Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization
Measured: 6 months after randomization
Secondary outcomes (6)
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
Measured: Within 1 month of procedure
Clinical Success
Resolution of jaundice due to obstruction in the bile duct
Measured: 1 month from procedure
Technical Success
Technical success is defined as successful stent insertion providing biliary drainage with confirmation of appropriate radiographic positioning
Measured: 1 month from procedure
Survival duration
Survival duration will be measured from time of diagnosis to death
Measured: 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)
Measured: 1 month from procedure
Quality of Life
QOL will be measured via QLQ-C30 questionnaires completed by the subject at each follow up visit
Measured: 1 year from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start18 Oct 2016
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Kahaleh, Weill Medical College of Cornell University
- Investigators
- Michel Kahaleh, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063554
- Sponsor's protocol ID
- 1603017104
- Acronym
- BILPAL
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-Guided Biliary Drainage (EUS-BD) Compared to Standard Transpapillary Biliary Drainage (ERCP-TP) for Palliation of Jaundice in Unresectable Cancer of the Head of the Pancreas (BILPAL TRIAL)
- ClinicalTrials.gov ID
- NCT03063554
- Acronym / sponsor ID
- BILPAL / 1603017104
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma, Biliary Tract Neoplasms, Biliary Duct Obstruction, Unresectable Pancreatic Cancer, Periampullary Cancer
- Keywords
- Endoscopy, Pancreatic Cancer, Bile duct, Periampullary, ERCP, Biliary drainage, Biliary obstruction, EUSBD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Ultrasound Guided Biliary Drainage | Active comparator | Procedure: Endoscopic Ultrasound Guided Biliary DrainageEndoscopic Ultrasound Guided biliary drainage with stent placement. EUS via either stomach or duodenum. |
| ERCP | Placebo comparator | Procedure: ERCPEndoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 90 years old
- Clinically indicated for biliary endoscopic drainage with Endoscopic Ultrasound guidance or ERCP
- CT scan has demonstrated a lesion in the pancreatic head area with metastases and/ or local tumor ingrowth preventing resection.
- CT with evidence of distant metastases or local tumor ingrowth into portal or mesenteric vessels (as defined by the tumor surrounding the vessel for at least 180 degrees of the circumference)
- A serum bilirubin level of > 2.5mg/dL at randomization
Key exclusion criteria (6 listed)
- > 90 years
- Severe comorbidity (Karnofsky <50%)
- Any prior successful previous biliary drainage including ERCP and stenting, percutaneous biliary and surgical,
- Prior surgically altered pancreaticobiliary or gastroduodenal anatomy.
- Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
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 |
|---|---|---|
| Endoscopic Ultrasound Guided Biliary DrainageAlso: EUSBDEndoscopic Ultrasound Guided biliary drainage with stent placement; | Procedure or surgery | Endoscopic Ultrasound Guided Biliary Drainage |
| ERCPAlso: ERCP-TPEndoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement | Procedure or surgery | ERCP |
Primary outcome
Efficacy of Stent Patency
Time frame: 6 months after randomization
Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization
6 secondary outcomes
Safety evaluation: Assessment of number and frequency of procedure related adverse events within 1 month of the procedure
Time frame: Within 1 month of procedure
Clinical Success
Time frame: 1 month from procedure
Technical Success
Time frame: 1 month from procedure
Survival duration
Time frame: 2 years from randomization
Serum bilirubin decrease
Time frame: 1 month from procedure
Quality of Life
Time frame: 1 year from study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Michel Kahaleh, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound Guided Biliary Drainage and ERCP in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Weill Medical College of Cornell University at 1 site in United States.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Kahaleh, MD (646-962-4797, mik9071@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Stent Patency (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2017.