Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Papillary Thyroid Cancer Clinical Trial

Official title:

Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510002
• Other study ID #: BBN/501/ZKL/1447
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: January 10, 2012
• Start date: January 1993
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative.

Description:

Several respected organizations have recently recommended that total thyroidectomy plus prophylactic central neck dissection should be the standard operation for papillary thyroid cancer. However, it is still unclear if this approach has any benefit on survival or locoregional control of the disease. In addition, potential advantages of this more aggressive surgical approach should outweigh the risk of morbidity. The purpose of this retrospective cohort study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative. In this study outcomes of total thyroidectomy versus this plus prophylactic central neck dissection for papillary thyroid cancer are compared in a 10-year follow-up. Patients operated between 1993 and 1997 (n=282) underwent total thyroidectomy alone, whereas patients operated between 1998 and 2002 (n=358) underwent total thyroidectomy plus prophylactic central neck dissection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a pathological diagnosis of papillary thyroid cancer,

• in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation

Exclusion Criteria:

• incidental diagnosis of papillary thyroid cancer following hemithyroidectomy and requiring completion thyroidectomy,

• one-stage lymph nodes dissection based on therapeutic intent,

• previous thyroid surgery,

• incomplete follow-up information,

• incomplete histopathology report,

• ASA grade higher than 3 (American Society of Anesthesiology)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Papillary Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Total thyroidectomy
Extracapsular total thyroidectomy
• Total thyroidectomy + prophylactic central neck dissection
Extracapsular total thyroidectomy plus prophylactic central neck dissection

Locations

Country	Name	City	State
Poland	Jagiellonian Univerity, Medical College, 3rd Department of General Surgery	Krakow	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (7)

Alvarado R, Sywak MS, Delbridge L, Sidhu SB. Central lymph node dissection as a secondary procedure for papillary thyroid cancer: Is there added morbidity? Surgery. 2009 May;145(5):514-8. doi: 10.1016/j.surg.2009.01.013. Epub 2009 Mar 27. — View Citation

Barczynski M, Konturek A, Stopa M, Cichon S, Richter P, Nowak W. Total thyroidectomy for benign thyroid disease: is it really worthwhile? Ann Surg. 2011 Nov;254(5):724-29; discussion 729-30. doi: 10.1097/SLA.0b013e3182360118. — View Citation

Forest VI, Clark JR, Ebrahimi A, Cho EA, Sneddon L, Gao K, O'brien CJ. Central compartment dissection in thyroid papillary carcinoma. Ann Surg. 2011 Jan;253(1):123-30. doi: 10.1097/SLA.0b013e3181fc9644. — View Citation

Grodski S, Cornford L, Sywak M, Sidhu S, Delbridge L. Routine level VI lymph node dissection for papillary thyroid cancer: surgical technique. ANZ J Surg. 2007 Apr;77(4):203-8. — View Citation

Moo TA, Umunna B, Kato M, Butriago D, Kundel A, Lee JA, Zarnegar R, Fahey TJ 3rd. Ipsilateral versus bilateral central neck lymph node dissection in papillary thyroid carcinoma. Ann Surg. 2009 Sep;250(3):403-8. doi: 10.1097/SLA.0b013e3181b3adab. — View Citation

Mulla M, Schulte KM. Central cervical lymph node metastases in papillary thyroid cancer: a systematic review of imaging-guided and prophylactic removal of the central compartment. Clin Endocrinol (Oxf). 2012 Jan;76(1):131-6. doi: 10.1111/j.1365-2265.2011.04162.x. Review. — View Citation

Popadich A, Levin O, Lee JC, Smooke-Praw S, Ro K, Fazel M, Arora A, Tolley NS, Palazzo F, Learoyd DL, Sidhu S, Delbridge L, Sywak M, Yeh MW. A multicenter cohort study of total thyroidectomy and routine central lymph node dissection for cN0 papillary thyroid cancer. Surgery. 2011 Dec;150(6):1048-57. doi: 10.1016/j.surg.2011.09.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		up to 10 years	No
Primary	disease-specific survival		up to 10 years	No
Primary	locoregional control		up to 10 years	No
Secondary	number of patients with negative serum thyroglobulin levels		up to 10 years	No
Secondary	postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).		up to 12 months	Yes