Percutaneous image-guided cryoablation of painful metastases involving bone: multicenter trial.
BACKGROUND
This study sought to describe the results of a single-arm multicenter clinical trial using image-guided percutaneous cryoablation for the palliation of painful metastatic tumors involving bone.


METHODS
Over a 44-month period, 61 adult patients with 1 or 2 painful bone metastases with a score of 4 or more on a scale of 0 to 10 (≥4/10) worst pain in a 24-hour period who had failed or refused conventional treatment were treated with percutaneous image-guided cryoablation. Patient pain and quality of life was measured using the Brief Pain Inventory prior to treatment, 1 and 4 days after the procedure, weekly for 4 weeks, and every 2 weeks thereafter for a total of 6 months. Patient analgesic use was also recorded at these same follow-up intervals. Complications were monitored. Analysis of the primary endpoint was undertaken via paired comparison procedures.


RESULTS
A total of 69 treated tumors ranged in size from 1 to 11 cm. Prior to cryoablation, the mean score for worst pain in a 24-hour period was 7.1/10 with a range of 4/10 to 10/10. At 1, 4, 8, and 24 weeks after treatment, the mean score for worst pain in a 24-hour period decreased to 5.1/10 (P < .0001), 4.0/10 (P < .0001), 3.6/10 (P < .0001), and 1.4/10 (P < .0001), respectively. One of 61 (2%) patients had a major complication with osteomyelitis at the site of ablation.


CONCLUSIONS
Percutaneous cryoablation is a safe, effective, and durable method for palliation of pain due to metastatic disease involving bone.
Department of Radiology, Mayo Clinic, Rochester, MN 55905, USA. callstrom.matthew@mayo.edu
Matthew R
MR
Callstrom
Damian E
DE
Dupuy
Stephen B
SB
Solomon
Robert A
RA
Beres
Peter J
PJ
Littrup
Kirkland W
KW
Davis
Ricardo
R
Paz-Fumagalli
Cheryl
C
Hoffman
Thomas D
TD
Atwell
J William
JW
Charboneau
Grant D
GD
Schmit
Matthew P
MP
Goetz
Joseph
J
Rubin
Kathy J
KJ
Brown
Paul J
PJ
Novotny
Jeff A
JA
Sloan
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001859:Bone Neoplasms / Q000556:secondary* / Q000601:surgery*; D003452:Cryosurgery / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000601:surgery; D010166:Palliative Care; D025321:Surgery, Computer-Assisted