Clinical trial · Interventional
EUS BD vs ERCP TP for Pancreatic Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Duct Obstruction | — | UNRESOLVED | — |
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
| Periampullary Carcinoma Non-Resectable | — | UNRESOLVED | — |
| Unresectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Ultrasound Guided Biliary Drainage | Procedure | — | UNRESOLVED |
| ERCP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic Ultrasound Guided Biliary Drainage
- description
- Endoscopic Ultrasound Guided biliary drainage with stent placement. EUS via either stomach or duodenum.
- interventionNames
- Procedure: Endoscopic Ultrasound Guided Biliary Drainage
- type
- PLACEBO_COMPARATOR
- label
- ERCP
- description
- Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only.
- interventionNames
- Procedure: ERCP
Primary outcomes (1)
- measure
- Efficacy of Stent Patency
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available