EUS Guided Celiac Neurolysis

Pancreatic Cancer Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615653
• Other study ID #: 09-005037
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: July 21, 2017
• Start date: September 2009
• Est. completion date: June 2015

Study information

• Verified date: July 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer Pain
• Pancreatic Neoplasms

Intervention

Procedure:
• EUS
EUS Guided Therapy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	American College of Gastroenterology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed using a numerical rating scale (NRS) from 0 to 10.	pain response will be measured	Baseline to 6 months