Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-01-01 @ 1:01 AM
Study NCT ID:
NCT02002806
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: