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

Indiana University

Status: Completed

Conditions: Biliary Tract Cancer; Pancreas Cancer

Treatments: Other: Placebo Injection; Other: Alcohol Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02002806

1011003552

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Alcohol Injection

Experimental group

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

Treatment:

Other: Alcohol Injection

Placebo Injection

Placebo Comparator group

Description:

Celiac plexus injection - placebo injection

Treatment:

Other: Placebo Injection