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

NCT02002806 | Completed DMC

• 1 other identifier: 1011003552
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer; Biliary Tract Cancer

Keywords

Pancreatic cancer; Pain

Outcome Measures

Primary Outcomes (1)

• Pain Control

  12 Months

Secondary Outcomes (1)

• Disease-specific, recurrence-free survival

  2 Years

Study Arms (2)

Alcohol Injection

EXPERIMENTAL

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

Other: Alcohol Injection

Placebo Injection

PLACEBO COMPARATOR

Celiac plexus injection - placebo injection

Other: Placebo Injection

Interventions

Alcohol Injection OTHER

Celiac plexus neurolysis by alcohol injection

Also known as: Ethanol Injection

Alcohol Injection

Placebo Injection OTHER

Also known as: Normal saline injection

Placebo Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Pain

Interventions

Ethanol; Saline Solution

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Michael G House, MD

  Indiana University, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)