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

Pancreas Cancer Clinical Trial

Official title:

A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002806
• Other study ID #: 1011003552
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Alcohol Injection
Celiac plexus neurolysis by alcohol injection
• Placebo Injection

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Control		12 Months
Secondary	Disease-specific, recurrence-free survival		2 Years