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Status unknownNCT03063554BILPALUpdated Feb 24, 2017

EUS BD vs ERCP TP for Pancreatic Cancer

An interventional study of Endoscopic Ultrasound Guided Biliary Drainage and ERCP in Pancreatic Cancer, Pancreatic Adenocarcinoma and Biliary Tract Neoplasms, sponsored by Weill Medical College of Cornell University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2016, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma
  • Biliary Tract Neoplasms
  • Biliary Duct Obstruction
  • Unresectable Pancreatic Cancer
  • Periampullary Cancer
  • Periampullary Carcinoma Non-Resectable

Keywords

  • Endoscopy
  • Pancreatic Cancer
  • Bile duct
  • Periampullary
  • ERCP
  • Biliary drainage
  • Biliary obstruction
  • EUSBD
  • TEUS
  • EUS
  • Endoscopic Ultrasound
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's planned enrollment of 120 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age between 18 and 90 years old
  2. Clinically indicated for biliary endoscopic drainage with Endoscopic Ultrasound guidance or ERCP
  3. CT scan has demonstrated a lesion in the pancreatic head area with metastases and/ or local tumor ingrowth preventing resection.
  4. 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)
  5. A serum bilirubin level of > 2.5mg/dL at randomization
  6. Deemed surgically unresectable
  7. Consents to participation in the randomized controlled trial

Exclusion criteria

Exclusion Criteria :

  1. > 90 years
  2. Severe comorbidity (Karnofsky \<50%)
  3. Any prior successful previous biliary drainage including ERCP and stenting, percutaneous biliary and surgical,
  4. Prior surgically altered pancreaticobiliary or gastroduodenal anatomy.
  5. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
  6. Currently participating in another device trial that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureEndoscopic Ultrasound Guided Biliary Drainage

    Endoscopic Ultrasound Guided biliary drainage with stent placement;

    Also known as: EUSBD

  • ProcedureERCP

    Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement

    Also known as: ERCP-TP

06

What researchers measure

Primary outcomes

  1. Efficacy of Stent Patency

    Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization

    Time frame: 6 months after randomization

Secondary outcomes

  1. 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

    Time frame: Within 1 month of procedure

  2. Clinical Success

    Resolution of jaundice due to obstruction in the bile duct

    Time frame: 1 month from procedure

  3. Technical Success

    Technical success is defined as successful stent insertion providing biliary drainage with confirmation of appropriate radiographic positioning

    Time frame: 1 month from procedure

  4. Survival duration

    Survival duration will be measured from time of diagnosis to death

    Time frame: 2 years from randomization

  5. Serum bilirubin decrease

    Duration to achieving at least 30% decrease in serum bilirubin or normalization of serum bilirubin level (≤1.2 mg/dL)

    Time frame: 1 month from procedure

  6. Quality of Life

    QOL will be measured via QLQ-C30 questionnaires completed by the subject at each follow up visit

    Time frame: 1 year from study enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2016 (actual). Primary completion is estimated for Sep 2018, 22 months after the start.

Of 352 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 71. This study's planned 22 months is below that.

Counting every sponsor, half of 373 studies reached it within 48 months; a quarter within 26 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2017
First posted
Feb 24, 2017
StartActual
Oct 18, 2016
Primary completionEst.
Sep 1, 2018
CompletionEst.
Oct 1, 2018
Last update
Feb 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03063554
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Michel Kahaleh (Chief of Endoscopy, Weill Medical College of Cornell University) — Principal investigator
First posted
Feb 24, 2017
Start date
Oct 18, 2016
Primary completion
Sep 1, 2018 (estimated)
Completion
Oct 1, 2018 (estimated)
Last update
Feb 24, 2017

Study contacts

Michel Kahaleh, MD
Contact
mik9071@med.cornell.edu
646-962-4797
Monica R Gaidhane, MPH
Contact
mog2012@med.cornell.edu
646-962-4796
Michel Kahaleh, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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