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EUS Guided Celiac Neurolysis

Primary Purpose

Pancreatic Cancer Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EUS
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer Pain focused on measuring Pancreatic cancer, Pancreas cancer, Pain, Celiac Plexus, Neurolysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS 1

EUS 2

Arm Description

Outcomes

Primary Outcome Measures

Pain assessed using a numerical rating scale (NRS) from 0 to 10.
pain response will be measured

Secondary Outcome Measures

Full Information

First Posted
April 17, 2012
Last Updated
July 21, 2017
Sponsor
Mayo Clinic
Collaborators
American College of Gastroenterology
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1. Study Identification

Unique Protocol Identification Number
NCT01615653
Brief Title
EUS Guided Celiac Neurolysis
Official Title
Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
American College of Gastroenterology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer Pain
Keywords
Pancreatic cancer, Pancreas cancer, Pain, Celiac Plexus, Neurolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS 1
Arm Type
Active Comparator
Arm Title
EUS 2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
EUS
Intervention Description
EUS Guided Therapy
Primary Outcome Measure Information:
Title
Pain assessed using a numerical rating scale (NRS) from 0 to 10.
Description
pain response will be measured
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30217513
Citation
Levy MJ, Gleeson FC, Topazian MD, Fujii-Lau LL, Enders FT, Larson JJ, Mara K, Abu Dayyeh BK, Alberts SR, Hallemeier CL, Iyer PG, Kendrick ML, Mauck WD, Pearson RK, Petersen BT, Rajan E, Takahashi N, Vege SS, Wang KK, Chari ST. Combined Celiac Ganglia and Plexus Neurolysis Shortens Survival, Without Benefit, vs Plexus Neurolysis Alone. Clin Gastroenterol Hepatol. 2019 Mar;17(4):728-738.e9. doi: 10.1016/j.cgh.2018.08.040. Epub 2018 Sep 12.
Results Reference
derived

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EUS Guided Celiac Neurolysis

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