EUS BD vs ERCP TP for Pancreatic Cancer (BILPAL)

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer; Pancreatic Adenocarcinoma; Periampullary Cancer; Biliary Tract Neoplasms; Unresectable Pancreatic Cancer; Biliary Duct Obstruction; Periampullary Carcinoma Non-Resectable
• Intervention / Treatment: Procedure: Endoscopic Ultrasound Guided Biliary Drainage; Procedure: ERCP

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical College
      • Contact: Monica R Gaidhane, MPH; Phone Number: Gaidhane 646-962-4796; Email: mog2012@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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; Endoscopic Ultrasound Guided biliary drainage with stent placement; Other Names: EUSBD
Placebo Comparator: ERCP; Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only.	Procedure: ERCP; Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement; Other Names: ERCP-TP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Endoscopy; ERCP; Biliary obstruction; EUS; Endoscopic Ultrasound; Biliary drainage; Bile duct; Periampullary; EUSBD; TEUS
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Biliary Tract Diseases; Pancreatic Diseases; Pancreatic Neoplasms; Biliary Tract Neoplasms
• Other Study ID Numbers: 1603017104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No