Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
This trial is active, not recruiting.
|Conditions||pancreas cancer, biliary tract cancer|
|Treatments||alcohol injection, placebo injection|
|Start date||January 2012|
|End date||December 2022|
|Trial size||150 participants|
|Trial identifier||NCT02002806, 1011003552|
This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator)|
time frame: 12 Months
Disease-specific, recurrence-free survival
time frame: 2 Years
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
|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.|
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