EUS BD vs ERCP TP for Pancreatic Cancer

NCT03063554 | Unknown DMC

• 1 other identifier: 1603017104
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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; Periampullary Cancer; Periampullary Carcinoma Non-Resectable

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Efficacy of Stent Patency

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

  6 months after randomization

Secondary Outcomes (6)

• Safety evaluation: Assessment of number and frequency of procedure related adverse events within 1 month of the procedure

  Within 1 month of procedure

• Clinical Success

  1 month from procedure

• Technical Success

  1 month from procedure

• Survival duration

  2 years from randomization

• Serum bilirubin decrease

  1 month from procedure

Study Arms (2)

Endoscopic Ultrasound Guided Biliary Drainage

ACTIVE COMPARATOR

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

Procedure: Endoscopic Ultrasound Guided Biliary Drainage

ERCP

PLACEBO COMPARATOR

Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only.

Procedure: ERCP

Interventions

Endoscopic Ultrasound Guided Biliary Drainage PROCEDURE

Endoscopic Ultrasound Guided biliary drainage with stent placement;

Also known as: EUSBD

Endoscopic Ultrasound Guided Biliary Drainage

ERCP PROCEDURE

Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement

Also known as: ERCP-TP

ERCP

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michel Kahaleh, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Kahaleh, MD

CONTACT

646-962-4797; mik9071@med.cornell.edu

Monica R Gaidhane, MPH

CONTACT

646-962-4796; mog2012@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endoscopy

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 24, 2017
• Study Start: October 18, 2016
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)