Endoscopic Ultrasound Versus Endoscopic Retrograde Cholangiopancreatography (ERCP) Tissue Sampling for the Diagnosis of Suspected Pancreatico-Biliary Cancer
Completed · Not applicable
Conditions studied: Pancreaticobiliary Cancers, Jaundice, Bile Duct Obstruction
In brief
The two most commonly used methods to biopsy suspected pancreaticobiliary masses are (1) endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) and (2) cytology brush biopsies obtained during endoscopic retrograde cholangiopancreatography (ERCP). At most centers, the specific method used depends on the availability of the technology and local expertise. Although it is believed that EUS-FNA is more accurate than ERCP brushings, there have been no head-to-head comparisons. The investigators' hypothesis is that EUS-FNA is superior to ERCP in obtaining tissue biopsies of pancreaticobiliary tumors, and the investigators aim to directly compare the two techniques.
Key facts
- Study ID
- NCT01356030
- Run by
- California Pacific Medical Center Research Institute
- People needed
- 51
- Starts
- 2011-05-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2013-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients age >18 years that are scheduled for EUS and possible ERCP for the evaluation of jaundice from suspected pancreaticobiliary tumors.
You may not qualify if…
- Patients that do not provide consent for EUS and ERCP (for standard clinical reasons)
- Patients that do not require ERCP based on EUS findings (e.g. no mass seen, mass is not causing jaundice
- Patients in whom an additional 5 minutes of procedure time may increase the procedural/sedation risks:
- pregnant patients
- patients with severe medical co-morbidities (ASA class 4 or 5)
- Patients with significant bleeding risk precluding endoscopic tissue sampling
- INR > 1.4 or Prothrombin time > 5 sec more than control
- Platelet count < 50,000
Where it is running
- California Pacific Medical Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
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