Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control

Not Applicable

Completed

• Conditions: Pancreas Cancer; Biliary Tract Cancer
• Interventions: Other: Alcohol Injection; Other: Placebo Injection

• Registration Number: NCT02002806
• Lead Sponsor: Indiana University

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-06
• Primary Completion: 2018-12
• Study Completion: 2019-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alcohol Injection	Alcohol Injection	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
Placebo Injection	Placebo Injection	Celiac plexus injection - placebo injection

Primary Outcome Measures

Name	Time	Method
Pain Control	12 Months

Secondary Outcome Measures

Name	Time	Method
Disease-specific, recurrence-free survival	2 Years

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States