Prophylactic Central Neck Dissection for Papillary Thyroid Cancer
1 other identifier
interventional
640
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 1993
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 9, 2012
CompletedFirst Posted
Study publicly available on registry
January 13, 2012
CompletedJanuary 13, 2012
January 1, 2012
18.7 years
January 9, 2012
January 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
overall survival
up to 10 years
disease-specific survival
up to 10 years
locoregional control
up to 10 years
Secondary Outcomes (2)
number of patients with negative serum thyroglobulin levels
up to 10 years
postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
up to 12 months
Study Arms (2)
TT
ACTIVE COMPARATORExtracapsular total thyroidectomy
TT+CND
EXPERIMENTALExtracapsular total thyroidectomy puls prophylactic central neck dissection
Interventions
Extracapsular total thyroidectomy plus prophylactic central neck dissection
Eligibility Criteria
You may qualify if:
- a pathological diagnosis of papillary thyroid cancer,
- in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jagiellonian Univerity, Medical College, 3rd Department of General Surgery
Krakow, Malopolska, 31-202, Poland
Related Publications (8)
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.
PMID: 21135696BACKGROUNDMulla 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.
PMID: 21722150BACKGROUNDPopadich 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.
PMID: 22136820BACKGROUNDAlvarado 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.
PMID: 19375610BACKGROUNDGrodski 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.
PMID: 17388820BACKGROUNDMoo 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.
PMID: 19661784BACKGROUNDBarczynski 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.
PMID: 22005150BACKGROUNDBarczynski 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.
PMID: 23188784DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcin Barczynski, MD, PhD
Jagiellonian University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 9, 2012
First Posted
January 13, 2012
Study Start
January 1, 1993
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
January 13, 2012
Record last verified: 2012-01