This trial is active, not recruiting.

Condition pancreatic cancer pain
Treatment eus
Sponsor Mayo Clinic
Collaborator American College of Gastroenterology
Start date September 2009
End date March 2014
Trial size 100 participants
Trial identifier NCT01615653, 09-005037


- Hypothesis:

- 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.

- Rationale:

- 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
(Active Comparator)
EUS Guided Therapy
(Active Comparator)
EUS Guided Therapy

Primary Outcomes

Pain assessed using a numerical rating scale (NRS) from 0 to 10.
time frame: Baseline to 6 months

Eligibility Criteria

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.

Additional Information

Official title Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.