Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules

NCT02714946 | Unknown

• 1 other identifier: Studio 96-15 CE 93321
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.

Conditions

Thyroid Nodule

Keywords

Thyroid Nodule; Percutaneous radiofrequency ablation (RFA); Percutaneous laser ablation (LA)

Outcome Measures

Primary Outcomes (1)

• Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment

  Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months

  12 months

Secondary Outcomes (7)

• Basal Volume of Thyroid Nodules as Predictive factor of response to treatment

  12 months

• Histopathological features of Thyroid Nodules as Predictive factor of response to treatment

  12 months

• Variation in TSH levels after treatment

  12 months

• Variation in AbTPO and AbTg levels after treatment

  12 months

• Complications

  Up to 1 year follow-up

Study Arms (2)

LA Arm

ACTIVE COMPARATOR

Percutaneous Laser Ablation

Device: Percutaneous Laser Ablation

RFA Arm

ACTIVE COMPARATOR

Percutaneous Radiofrequency Ablation

Device: Percutaneous Radiofrequency Ablation

Interventions

Percutaneous Laser Ablation DEVICE

Single session with standardized approach: One or two fibers will be used for treatments including one to three illuminations with a fixed output power of 3 W, using the pullback technique. Energy for each emission will be 1200-1800J based on nodule volume. The treatment is performed under local anesthesia and conscious sedation.

LA Arm

Percutaneous Radiofrequency Ablation DEVICE

Single session with standardized approach: A radiofrequency generator and a 17-gauge, 15-cm electrode with a 1-cm active tip will be used. A transisthmic approach along the short axis of the nodule will be used and the nodules will be managed with the moving-shot technique. 60 W of radiofrequency outpower will be used for all nodules. The treatment is performed under local anesthesia and conscious sedation

RFA Arm

Eligibility Criteria

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

You may qualify if:

• Solitary thyroid nodule or dominating nodule which is well-identifiable in multinodular goiter.
• Compressive and /or cosmetic symptoms caused by thyroid nodule or increase in nodule volume \>20% in 1 year even without symptoms
• A nodule volume ≥ 5 ml
• Solid nodule (uniformly compact or nearly completely solid, with a liquid component not exceeding 30%);
• Two thyroid biopsies resulted negative for malignancy
• Calcitonin levels within normal ranges

You may not qualify if:

• Hyperfunctioning lesion as evaluated biochemically and/or by 99mTc scintigraphy
• Pregnancy

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Santa Maria Goretti Hospital

Latina, 04100, Italy

Location

Related Publications (5)

• Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus L, Vitti P; AACE/AME/ETA Task Force on Thyroid Nodules. American Association of Clinical Endocrinologists, Associazione Medici Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules: executive summary of recommendations. J Endocrinol Invest. 2010;33(5 Suppl):51-6.

  PMID: 20543551 BACKGROUND

• Pacella CM, Bizzarri G, Guglielmi R, Anelli V, Bianchini A, Crescenzi A, Pacella S, Papini E. Thyroid tissue: US-guided percutaneous interstitial laser ablation-a feasibility study. Radiology. 2000 Dec;217(3):673-7. doi: 10.1148/radiology.217.3.r00dc09673.

  PMID: 11110927 BACKGROUND

• Ahmed M, Brace CL, Lee FT Jr, Goldberg SN. Principles of and advances in percutaneous ablation. Radiology. 2011 Feb;258(2):351-69. doi: 10.1148/radiol.10081634.

  PMID: 21273519 BACKGROUND

• Papini E, Guglielmi R, Bizzarri G, Graziano F, Bianchini A, Brufani C, Pacella S, Valle D, Pacella CM. Treatment of benign cold thyroid nodules: a randomized clinical trial of percutaneous laser ablation versus levothyroxine therapy or follow-up. Thyroid. 2007 Mar;17(3):229-35. doi: 10.1089/thy.2006.0204.

  PMID: 17381356 BACKGROUND

• Cesareo R, Pasqualini V, Simeoni C, Sacchi M, Saralli E, Campagna G, Cianni R. Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules. J Clin Endocrinol Metab. 2015 Feb;100(2):460-6. doi: 10.1210/jc.2014-2186. Epub 2014 Nov 11.

  PMID: 25387256 BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Roberto Cianni

  Santa Maria Goretti Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 22, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)