EUS BD vs ERCP TP for Pancreatic Cancer

NCT ID: NCT03063554

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-18
• Study Completion Date: 2018-10-01

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.

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; Periampullary Carcinoma Non-Resectable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Ultrasound Guided Biliary Drainage

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

Group Type: ACTIVE_COMPARATOR

Endoscopic Ultrasound Guided Biliary Drainage

Intervention Type: PROCEDURE

Endoscopic Ultrasound Guided biliary drainage with stent placement;

ERCP

Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only.

Group Type: PLACEBO_COMPARATOR

ERCP

Intervention Type: PROCEDURE

Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement

Interventions

Endoscopic Ultrasound Guided Biliary Drainage

Endoscopic Ultrasound Guided biliary drainage with stent placement;

Intervention Type: PROCEDURE

ERCP

Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement

Intervention Type: PROCEDURE

Other Intervention Names

EUSBD; ERCP-TP

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Michel Kahaleh

Chief of Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Kahaleh, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michel Kahaleh, MD

Role: CONTACT

mik9071@med.cornell.edu

646-962-4797

Monica R Gaidhane, MPH

Role: CONTACT

mog2012@med.cornell.edu

646-962-4796

Facility Contacts

Michel Kahaleh, MD

Role: primary

mik9071@med.cornell.edu

646-962-4797

Monica R Gaidhane, MPH

Role: backup

mog2012@med.cornell.edu

646-962-4796 ext. Gaidhane

Other Identifiers

1603017104

Identifier Type: -

Identifier Source: org_study_id