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Percutaneous Cordotomy for Pain Palliation in Advanced Cancer: A Randomized Clinical Trial Study Protocol. Neurosurgery 2020 Aug 01;87(2):394-402

Date

02/06/2020

Pubmed ID

32012217

Pubmed Central ID

PMC7360878

DOI

10.1093/neuros/nyz527

Scopus ID

2-s2.0-85088494859 (requires institutional sign-in at Scopus site)   4 Citations

Abstract

BACKGROUND: Cancer pain, one of the most common symptoms for patients with advanced cancer, is often refractory to maximal medical therapy. A controlled clinical trial is needed to provide definitive evidence to support the use of ablative procedures such as cordotomy for patients with medically refractory cancer pain.

OBJECTIVE: To assess the efficacy of cordotomy for patients with unilateral advanced cancer pain using a controlled clinical trial study design. The secondary objectives are to define the patient experience of cordotomy for medically refractory cancer pain as well as to determine the utility of magnetic resonance imaging as a non-invasive biomarker for successful cordotomy.

METHODS: We will undertake a single-institution, double-blind, sham-controlled clinical trial of cordotomy in patients with refractory cancer pain. Patients in the cordotomy arm will undergo a percutaneous computed tomography-guided cordotomy at C1-C2, while patients in the control arm will undergo a similar procedure where the needle will not penetrate the thecal sac. The primary endpoint will be the reduction in pain intensity, as measured by the Edmonton Symptoms Assessment Scale.

EXPECTED OUTCOMES: We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.

DISCUSSION: This randomized clinical trial comparing cordotomy with a control intervention will provide the level of evidence necessary to determine whether cordotomy should be the standard of care intervention for patients with advanced cancer pain.

Author List

Viswanathan A, Vedantam A, Williams LA, Koyyalagunta D, Abdi S, Dougherty PM, Mendoza T, Bassett RL, Hou P, Bruera E

Author

Aditya Vedantam MD Assistant Professor in the Neurosurgery department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adult
Cancer Pain
Cordotomy
Double-Blind Method
Female
Humans
Male
Pain Management
Pain, Intractable
Randomized Controlled Trials as Topic
Surgery, Computer-Assisted
Tomography, X-Ray Computed