Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer
A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer
3 other identifiers
interventional
438
1 country
1
Brief Summary
Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol block) in patients undergoing surgical intervention for pancreatic cancer will result in a decrease in cancer associated pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pancreatic-cancer
Started Sep 2008
Typical duration for phase_3 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 10, 2008
CompletedFirst Posted
Study publicly available on registry
December 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMay 15, 2025
May 1, 2025
4.6 years
December 10, 2008
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is cancer related pain control.
Increased pain at 12 months in subjects with resectable tumors; increased pain at 3 months in subjects with unresectable tumors
Study Arms (2)
50% Ethanol
EXPERIMENTALOperating surgeon injects 20 ml of 50% ethanol on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
Placebo
PLACEBO COMPARATOROperating surgeon injects 20 ml of saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
Interventions
Operating surgeon by injecting 20 ml of either 50% ethanol or saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
Eligibility Criteria
You may qualify if:
- Preoperative imaging indicates possibility of resectable pancreatic cancer
- Intraoperative biopsy histologically confirming pancreatic adenocarcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
Lavu H, Lengel HB, Sell NM, Baiocco JA, Kennedy EP, Yeo TP, Burrell SA, Winter JM, Hegarty S, Leiby BE, Yeo CJ. A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma. J Am Coll Surg. 2015 Apr;220(4):497-508. doi: 10.1016/j.jamcollsurg.2014.12.013. Epub 2014 Dec 17.
PMID: 25667135DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harish Lavu, MD
Thomas Jefferson University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2008
First Posted
December 11, 2008
Study Start
September 1, 2008
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
May 15, 2025
Record last verified: 2025-05