EUS BD vs ERCP TP for Pancreatic Cancer

Not Applicable

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

• Registration Number: NCT03063554
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10-18
• Status Verified: 2017-02
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24
• Primary Completion: 2018-09-01
• Study Completion: 2018-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERCP	ERCP	Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only.
Endoscopic Ultrasound Guided Biliary Drainage	Endoscopic Ultrasound Guided Biliary Drainage	Endoscopic Ultrasound Guided biliary drainage with stent placement. EUS via either stomach or duodenum.

Primary Outcome Measures

Name	Time	Method
Efficacy of Stent Patency	6 months after randomization	Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization

Secondary Outcome Measures

Name	Time	Method
Quality of Life	1 year from study enrollment	QOL will be measured via QLQ-C30 questionnaires completed by the subject at each follow up visit
Serum bilirubin decrease	1 month from procedure	Duration to achieving at least 30% decrease in serum bilirubin or normalization of serum bilirubin level (≤1.2 mg/dL)
Safety evaluation: Assessment of number and frequency of procedure related adverse events within 1 month of the procedure	Within 1 month of procedure	Assessment of number and frequency of procedure related adverse events within 1 month of the procedure
Clinical Success	1 month from procedure	Resolution of jaundice due to obstruction in the bile duct
Technical Success	1 month from procedure	Technical success is defined as successful stent insertion providing biliary drainage with confirmation of appropriate radiographic positioning
Survival duration	2 years from randomization	Survival duration will be measured from time of diagnosis to death

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States