EUS Guided Celiac Neurolysis

Mayo Clinic

Status: Completed

Conditions: Pancreatic Cancer Pain

Treatments: Procedure: EUS

Study type: Interventional

Funder types: Other

Identifiers

NCT01615653

09-005037

Details and patient eligibility

About

• 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.

Enrollment: 110 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

EUS 1

Active Comparator group

Treatment:

Procedure: EUS

EUS 2

Active Comparator group

Treatment:

Procedure: EUS