Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer, Chronic Pain, Pancreatic Cancer |
Therapuetic Areas: | Musculoskeletal, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | June 2009 |
End Date: | December 2012 |
Contact: | Shyam Varadarajulu, MD |
Email: | svaradar@uabmc.edu |
Phone: | 205-996-4059 |
EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial
The purpose of this study is to examine endoscopic ultrasound guided celiac plexus
neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as
it applies to decreasing the severity of abdominal pain when compared to analgesic therapy
alone.
The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic
therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when
compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the
changes in reported pain severity between those who receive EUS-CPN in addition to analgesic
therapy as compared to analgesic therapy alone.
The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy
in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when
compared to when compared with analgesic therapy alone, compare pain medication usage
between Group 1 when compared to Group 2, and compare the referral for rescue block during
the course of the study between Group 1 and Group 2
Inclusion Criteria:
1. Male or Female
2. Age ≥19 yrs old
3. Abdominal pain typical for pancreatic cancer ≥3/10
4. Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
5. Pancreatic cancer confirmed by FNA during EUS
6. Inoperability of pancreatic cancer as determined during EUS or prior CT
Exclusion Criteria:
1. Age < 19 yrs old
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (prolongation of prothrombin time > 18 sec, thrombocytopenia <80,000
platelets/ml)
4. Previous CPN or other neurolytic block that could affect pancreatic cancer -related
pain or had implanted epidural or intrathecal analgesic therapy
5. Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal
disorder
6. Potential patient noncompliance (refusing to follow schedule of events)
7. Active alcohol or other drug use or significant psychiatric illness
8. Pregnant or breastfeeding
9. Unable to consent
10. Non-English speaking
We found this trial at
2
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Florida Hospital Florida Hospital is one of the country
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