EUS BD vs ERCP TP for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— BILPAL  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03063554
• Other study ID #: 1603017104
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2017
• Last updated: February 20, 2017
• Start date: October 18, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: Michel Kahaleh, MD
• Phone: 646-962-4797
• Email: mik9071[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 due to unresectable pancreatic head or periampullary tumor.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Endoscopic Ultrasound Guided Biliary Drainage
Endoscopic Ultrasound Guided biliary drainage with stent placement;
• ERCP
Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Stent Patency	Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization	6 months after randomization
Secondary	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
Secondary	Clinical Success	Resolution of jaundice due to obstruction in the bile duct	1 month from procedure
Secondary	Technical Success	Technical success is defined as successful stent insertion providing biliary drainage with confirmation of appropriate radiographic positioning	1 month from procedure
Secondary	Survival duration	Survival duration will be measured from time of diagnosis to death	2 years from randomization
Secondary	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
Secondary	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