CompletedNCT01510002Updated Jan 13, 2012

Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

An interventional study of Total thyroidectomy and Total thyroidectomy + prophylactic central neck dissection in Papillary Thyroid Cancer, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-13.

Sponsored by Jagiellonian University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 640
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Papillary Thyroid Cancer

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Keywords

papillary thyroid cancer
central neck dissection
survival
locoregional control
morbidity

In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's enrollment of 640 is above the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

a pathological diagnosis of papillary thyroid cancer,
in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 640 participants (actual)

Study arms

Active comparator
TT
Extracapsular total thyroidectomy
Procedure: Total thyroidectomy
Experimental
TT+CND
Extracapsular total thyroidectomy puls prophylactic central neck dissection
Procedure: Total thyroidectomy + prophylactic central neck dissection

Interventions

ProcedureTotal thyroidectomy
Extracapsular total thyroidectomy
ProcedureTotal thyroidectomy + prophylactic central neck dissection
Extracapsular total thyroidectomy plus prophylactic central neck dissection

What researchers measure

Primary outcomes

overall survival
Time frame: up to 10 years
disease-specific survival
Time frame: up to 10 years
locoregional control
Time frame: up to 10 years

Secondary outcomes

number of patients with negative serum thyroglobulin levels
Time frame: up to 10 years
postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
Time frame: up to 12 months

Study locations

1 site

Jagiellonian Univerity, Medical College, 3rd Department of General Surgery
Krakow, Malopolska 31-202, Poland

References and documents

Publications

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. PubMed 21135696 ↗
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. PubMed 21722150 ↗
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. PubMed 22136820 ↗
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. PubMed 19375610 ↗
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. PubMed 17388820 ↗
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. PubMed 19661784 ↗
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. PubMed 22005150 ↗
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. PubMed 23188784 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01510002
Lead sponsor: Jagiellonian University
Responsible party: Marcin Barczynski (Principal Investigator, Jagiellonian University) — Principal investigator
First posted: Jan 13, 2012
Start date: Jan 1993
Primary completion: Sep 2011
Completion: Dec 2011
Last update: Jan 13, 2012

Study contacts

Marcin Barczynski, MD, PhD

principal investigator · Jagiellonian University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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