Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

NCT ID: NCT01510002

Last Updated: 2012-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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

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Papillary Thyroid Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TT

Extracapsular total thyroidectomy

Group Type ACTIVE_COMPARATOR

Total thyroidectomy

Intervention Type PROCEDURE

Extracapsular total thyroidectomy

TT+CND

Extracapsular total thyroidectomy puls prophylactic central neck dissection

Group Type EXPERIMENTAL

Total thyroidectomy + prophylactic central neck dissection

Intervention Type PROCEDURE

Extracapsular total thyroidectomy plus prophylactic central neck dissection

Interventions

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Total thyroidectomy

Extracapsular total thyroidectomy

Intervention Type PROCEDURE

Total thyroidectomy + prophylactic central neck dissection

Extracapsular total thyroidectomy plus prophylactic central neck dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Marcin Barczynski

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcin Barczynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

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Jagiellonian Univerity, Medical College, 3rd Department of General Surgery

Krakow, Malopolska, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 21135696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21722150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22136820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19375610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17388820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19661784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22005150 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23188784 (View on PubMed)

Other Identifiers

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BBN/501/ZKL/1447

Identifier Type: -

Identifier Source: org_study_id

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