EUS Guided Celiac Neurolysis
Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 25, 2017
July 1, 2017
4.8 years
April 17, 2012
July 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain assessed using a numerical rating scale (NRS) from 0 to 10.
pain response will be measured
Baseline to 6 months
Study Arms (2)
EUS 1
ACTIVE COMPARATOREUS 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
- \. Cytologic or histologic confirmation of pancreatic carcinoma
- \. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
- \. EUS clinically indicated (for non-study purposes)
You may not qualify if:
- \. Uncorrectable coagulopathy: (INR) \> 1.5 and/or platelets \< 50,000
- \. Abdominal surgery within 1 month
- \. Prior celiac plexus or ganglia neurolysis.
- \. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
- \. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- American College of Gastroenterologycollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55906, United States
Related Publications (1)
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.
PMID: 30217513DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
April 17, 2012
First Posted
June 8, 2012
Study Start
September 1, 2009
Primary Completion
June 1, 2014
Study Completion
June 1, 2015
Last Updated
July 25, 2017
Record last verified: 2017-07