Clinical trial NCT03063554: EUS BD vs ERCP TP for Pancreatic Cancer
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of Stent Patency
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Safety evaluation: Assessment of number and frequency of procedure related adverse events within 1 month of the procedure
timeFrame: Within 1 month of procedure
measure: Clinical Success
timeFrame: 1 month from procedure
measure: Technical Success
timeFrame: 1 month from procedure
measure: Survival duration
timeFrame: 2 years from randomization
measure: Serum bilirubin decrease
timeFrame: 1 month from procedure
measure: Quality of Life
timeFrame: 1 year from study enrollment
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References: