Overview

This trial is active, not recruiting.

Conditions pancreas cancer, biliary tract cancer
Treatments alcohol injection, placebo injection
Sponsor Indiana University
Start date January 2012
End date December 2022
Trial size 150 participants
Trial identifier NCT02002806, 1011003552

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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
alcohol injection Ethanol Injection
Celiac plexus neurolysis by alcohol injection
(Placebo Comparator)
Celiac plexus injection - placebo injection
placebo injection Normal saline injection

Primary Outcomes

Measure
Pain Control
time frame: 12 Months

Secondary Outcomes

Measure
Disease-specific, recurrence-free survival
time frame: 2 Years

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
Principal investigator Michael G House, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Indiana University.