Back to resultsSurgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
Primary Purpose
Pancreas Cancer, Biliary Tract Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol Injection
Placebo Injection
Sponsored by
About this trial
This is an interventional treatment trial for Pancreas Cancer focused on measuring Pancreatic cancer, Pain
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
Sites / Locations
- Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Alcohol Injection
Placebo Injection
Arm 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
Celiac plexus injection - placebo injection
Outcomes
Primary Outcome Measures
Pain Control
Secondary Outcome Measures
Disease-specific, recurrence-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02002806
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Biliary Tract Cancer
Keywords
Pancreatic cancer, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcohol Injection
Arm Type
Experimental
Arm 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
Arm Title
Placebo Injection
Arm Type
Placebo Comparator
Arm Description
Celiac plexus injection - placebo injection
Intervention Type
Other
Intervention Name(s)
Alcohol Injection
Other Intervention Name(s)
Ethanol Injection
Intervention Description
Celiac plexus neurolysis by alcohol injection
Intervention Type
Other
Intervention Name(s)
Placebo Injection
Other Intervention Name(s)
Normal saline injection
Primary Outcome Measure Information:
Title
Pain Control
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Disease-specific, recurrence-free survival
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G House, MD
Organizational Affiliation
Indiana University, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
We'll reach out to this number within 24 hrs