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Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain


Phase 4
N/A
N/A
Open (Enrolling)
Both
Pancreatic Cancer Pain

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Trial Information

Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Pain assessed using a numerical rating scale (NRS) from 0 to 10.

Outcome Description:

pain response will be measured

Outcome Time Frame:

Baseline to 6 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

09-005037

NCT ID:

NCT01615653

Start Date:

September 2009

Completion Date:

September 2014

Related Keywords:

  • Pancreatic Cancer Pain
  • Pancreatic cancer
  • Pancreas cancer
  • Pain
  • Celiac Plexus
  • Neurolysis
  • Pancreatic Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905