Clarian Health: Indiana University Hospital
Indianapolis, Indiana, 46202, United States
NCT Number: NCT00578279
The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.
Hypotheses:
1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma. 2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL)
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Indianapolis, Indiana, 46202, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects must not have a coagulopathy (platelet <50,000, INR>1.5, or bleeding disorder, or on blood thinners) Subjects with platelets below 50,000 will not be eligible to participate in this study due to the risk of bleeding. Patients will be asked to discontinue use of non-steroidals for 5 days prior to the procedure. Patients on plavix will be asked to discontinue use for 7 days prior to the procedure if they are clinically able to do so. Patients on coumadin or lovenox will also need to discontinue use prior to the procedure, but decisions regarding their management will be made on an individual basis as per our usual standards of care.
Exclusion criteria
subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure
Time frame: baseline up to 1 year
Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain.
Indiana University
Other
Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN) With Alcohol in Patients With Locally Advanced and Unresectable Pancreatic Adenocarcinoma: A Randomized Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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