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Completed

NCT Number: NCT02002806

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

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol Injection

Other

Celiac plexus neurolysis by alcohol injection

Other names: Ethanol Injection

Placebo Injection

Other

Other names: Normal saline injection

Primary outcomes

  1. Pain Control

    Time frame: 12 Months

Secondary outcomes

  1. Disease-specific, recurrence-free survival

    Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Dec 6, 2013
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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