Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control



Status:Active, not recruiting
Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 85
Updated:4/26/2018
Start Date:January 2012
End Date:December 2024

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A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies

This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo
for pain control in subjects with pancreatic cancer.

Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct
cancer.

Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with
ethanol injection versus surgery plus placebo injection. Subjects will be followed every
three months for survivorship or death to assess pain, quality of life measures, and narcotic
pain control usage. The primary endpoint of pain control will be determined at one year post
surgery. Subjects are not required to undergo any additional diagnostic testing procedures
that are not part of their routine follow-up care.

Inclusion Criteria:

This study will be offered to all patients scheduled to undergo open or laparoscopic
operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or
distal biliary tract cancer.

- Physiologic suitability for major abdominal surgery

- Aged 18 years and older

- Written informed consent

- Ability to understand and comply with study guidelines.

Exclusion Criteria:

- Pregnancy

- Previous, preoperative celiac nerve block

- Neoadjuvant chemotherapy or radiation therapy

- Incomplete tumor resection (R2 resection, grossly positive resection margin)

- Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative
findings

- Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up
or intraoperative findings

- Known metastatic disease
We found this trial at
1
site
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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from
Indianapolis, IN
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