EUS BD vs ERCP TP for Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

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

Intervention / Treatment
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* Procedure: Endoscopic Ultrasound Guided Biliary Drainage
* Procedure: ERCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria : > 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic Ultrasound Guided Biliary Drainage<br>Endoscopic Ultrasound Guided biliary drainage with stent placement. EUS via either stomach or duodenum. | Procedure: Endoscopic Ultrasound Guided Biliary Drainage<br>* Endoscopic Ultrasound Guided biliary drainage with stent placement;<br>* Other names: EUSBD;|
| Placebo Comparator: ERCP<br>Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only. | Procedure: ERCP<br>* Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement<br>* Other names: ERCP-TP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Stent Patency | Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization | 6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Clinical Success | Resolution of jaundice due to obstruction in the bile duct | 1 month from procedure | 
| Technical Success | Technical success is defined as successful stent insertion providing biliary drainage with confirmation of appropriate radiographic positioning | 1 month from procedure | 
| Survival duration | Survival duration will be measured from time of diagnosis to death | 2 years from randomization | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, Pancreatic Cancer, Bile duct, Periampullary, ERCP, Biliary drainage, Biliary obstruction, EUSBD, TEUS, EUS, Endoscopic Ultrasound