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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002806
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Michael G. House, 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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Biliary Tract Cancer Other: Alcohol Injection Other: Placebo Injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
Study Start Date : January 2012
Actual Primary Completion Date : December 2018
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Other: Alcohol Injection
Celiac plexus neurolysis by alcohol injection
Other Name: Ethanol Injection

Placebo Comparator: Placebo Injection
Celiac plexus injection - placebo injection
Other: Placebo Injection
Other Name: Normal saline injection




Primary Outcome Measures :
  1. Pain Control [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Disease-specific, recurrence-free survival [ Time Frame: 2 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002806


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Michael G House, MD Indiana University, Department of Surgery
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Responsible Party: Michael G. House, Associate Professor of Surgery, Indiana University
ClinicalTrials.gov Identifier: NCT02002806    
Other Study ID Numbers: 1011003552
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael G. House, Indiana University:
Pancreatic cancer
Pain
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs