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Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Primary Purpose

Papillary Thyroid Cancer

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Total thyroidectomy
Total thyroidectomy + prophylactic central neck dissection
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papillary Thyroid Cancer focused on measuring papillary thyroid cancer, central neck dissection, survival, locoregional control, morbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TT

TT+CND

Arm Description

Extracapsular total thyroidectomy

Extracapsular total thyroidectomy puls prophylactic central neck dissection

Outcomes

Primary Outcome Measures

overall survival
disease-specific survival
locoregional control

Secondary Outcome Measures

number of patients with negative serum thyroglobulin levels
postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).

Full Information

First Posted
January 9, 2012
Last Updated
January 10, 2012
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT01510002
Brief Title
Prophylactic Central Neck Dissection for Papillary Thyroid Cancer
Official Title
Prophylactic Central Neck Dissection for Papillary Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 1993 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Cancer
Keywords
papillary thyroid cancer, central neck dissection, survival, locoregional control, morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TT
Arm Type
Active Comparator
Arm Description
Extracapsular total thyroidectomy
Arm Title
TT+CND
Arm Type
Experimental
Arm Description
Extracapsular total thyroidectomy puls prophylactic central neck dissection
Intervention Type
Procedure
Intervention Name(s)
Total thyroidectomy
Intervention Description
Extracapsular total thyroidectomy
Intervention Type
Procedure
Intervention Name(s)
Total thyroidectomy + prophylactic central neck dissection
Intervention Description
Extracapsular total thyroidectomy plus prophylactic central neck dissection
Primary Outcome Measure Information:
Title
overall survival
Time Frame
up to 10 years
Title
disease-specific survival
Time Frame
up to 10 years
Title
locoregional control
Time Frame
up to 10 years
Secondary Outcome Measure Information:
Title
number of patients with negative serum thyroglobulin levels
Time Frame
up to 10 years
Title
postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Barczynski, MD, PhD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jagiellonian Univerity, Medical College, 3rd Department of General Surgery
City
Krakow
State/Province
Malopolska
ZIP/Postal Code
31-202
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21135696
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.
Results Reference
background
PubMed Identifier
21722150
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.
Results Reference
background
PubMed Identifier
22136820
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.
Results Reference
background
PubMed Identifier
19375610
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.
Results Reference
background
PubMed Identifier
17388820
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.
Results Reference
background
PubMed Identifier
19661784
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.
Results Reference
background
PubMed Identifier
22005150
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.
Results Reference
background
PubMed Identifier
23188784
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.
Results Reference
derived

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Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

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