Clinical trial NCT01510002: Prophylactic Central Neck Dissection for Papillary Thyroid Cancer
Official title: Prophylactic Central Neck Dissection for Papillary Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillary Thyroid Cancer
Keywords: papillary thyroid cancer
central neck dissection
survival
locoregional control
morbidity
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: overall survival
timeFrame: up to 10 years
measure: disease-specific survival
timeFrame: up to 10 years
measure: locoregional control
timeFrame: up to 10 years
Secondary outcomes:
measure: number of patients with negative serum thyroglobulin levels
timeFrame: up to 10 years
measure: postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian Univerity, Medical College, 3rd Department of General Surgery
state: Malopolska
Study officials:
affiliation: Jagiellonian University
name: Marcin Barczynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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. doi: 10.1111/j.1445-2197.2007.04019.x.
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.
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.
citation: Barczynski M, Konturek A, Stopa M, Nowak W. Prophylactic central neck dissection for papillary thyroid cancer. Br J Surg. 2013 Feb;100(3):410-8. doi: 10.1002/bjs.8985. Epub 2012 Nov 27.