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

Indiana University logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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