Recruiting

EUS-BD vs. ERCP-TP

Sponsor:

Weill Medical College of Cornell University

Code:

NCT03063554

Conditions

Pancreatic Cancer

Pancreatic Adenocarcinoma

Biliary Tract Neoplasms

Biliary Duct Obstruction

Unresectable Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Ultrasound Guided Biliary Drainage

ERCP

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Pancreatic Adenocarcinoma

Biliary Tract Neoplasms

Biliary Duct Obstruction

Unresectable Pancreatic Cancer

Study ID

NCT03063554

Start date

Oct 18, 2016

Status verified date

Feb, 2017

Completion date

Oct 1, 2018

Anticipated

Primary completion date

Sep 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 :

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Endoscopic Ultrasound Guided Biliary Drainage

Endoscopic Ultrasound Guided biliary drainage with stent placement. EUS via either stomach or duodenum.

placebo comparator: ERCP

Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only.

Interventions

Endoscopic Ultrasound Guided Biliary Drainage

Endoscopic Ultrasound Guided biliary drainage with stent placement;

ERCP

Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement

Primary outcome measure

  • Efficacy of Stent Patency [ Time Frame: 6 months after randomization ]

Central Contacts and Locations

Central contacts

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 24, 2017

Last verified

Feb, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2017-02-24.