EUS Guided Celiac Neurolysis
This trial is active, not recruiting.
|Condition||pancreatic cancer pain|
|Collaborator||American College of Gastroenterology|
|Start date||September 2009|
|End date||March 2014|
|Trial size||100 participants|
|Trial identifier||NCT01615653, 09-005037|
- Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
- Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Pain assessed using a numerical rating scale (NRS) from 0 to 10.
time frame: Baseline to 6 months
Male or female participants of any age.
Inclusion Criteria: - 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease - 2. Cytologic or histologic confirmation of pancreatic carcinoma - 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days - 4. EUS clinically indicated (for non-study purposes) Exclusion Criteria: - 1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000 - 2. Abdominal surgery within 1 month - 3. Prior celiac plexus or ganglia neurolysis. - 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days. - 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
|Official title||Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain|
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