Brief Title
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
Official Title
A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
Brief Summary
This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo
for pain control in subjects with pancreatic cancer.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Pain Control
Secondary Outcome
Disease-specific, recurrence-free survival
Condition
Pancreas Cancer
Intervention
Alcohol Injection
Study Arms / Comparison Groups
Alcohol Injection
Description: Celiac plexus neurolysis by alcohol injection One time administration during surgery 20 ml of alcohol injection on each side of aorta at level of celiac axis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
150
Start Date
January 2012
Completion Date
June 2019
Primary Completion Date
December 2018
Eligibility Criteria
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
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Michael G House, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02002806
Organization ID
1011003552
Responsible Party
Principal Investigator
Study Sponsor
Indiana University
Study Sponsor
Michael G House, MD, Principal Investigator, Indiana University, Department of Surgery
Verification Date
August 2019