Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
Primary Purpose
Papillary Thyroid Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Total thyroidectomy and central neck dissection
Sponsored by
About this trial
This is an interventional treatment trial for Papillary Thyroid Carcinoma focused on measuring papillary carcinoma, recurrence of PTC, Radio-iodine therapy for PTC
Eligibility Criteria
Inclusion Criteria:
- Age ≥20 years, Histopathology proved PTC, with no lymph nodes detected (N0)
Exclusion Criteria:
- Younger age ≤20 years. Prior thyroidectomy, previous radiation exposure, postoperative radioactive iodine therapy, Histopathology report of any type of malignancy other than PTC or patients did not complete their postoperative follow-up period. PTC With N1 or N2
Sites / Locations
- Zagazig University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Comparison between the studied groups regarding management.
Recurrence free survival
Arm Description
The postoperative RAI scan after 1 month, showed a positive residual tumour in lateral LN in 70 patients in the controlled group and 13 patients in Group II, 8 patients in group III. In group I, Patients with residuals were submitted to RAI ablation.
patients with total thyroidectomy only had shorter recurrence free survival
Outcomes
Primary Outcome Measures
recurrence free survival
recurrence free survival calculated from first day of diagnosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04336696
Brief Title
Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
Official Title
Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
April 3, 2020 (Anticipated)
Study Completion Date
May 3, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bassem Mohamed Sieda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
study assigned into three groups, Group I was the control group operated by total thyroidectomy and retrospectively followed, where the other two groups Operated by Total thyroidectomy and central neck dissection. Recurrence Free Survival (RFS) was the main issue of the study and calculated as the time from date of surgery to date of relapse or the most recent follow-up contact that patient was known as relapse-free, Study exclusively studied the outcome and advantage of central neck dissection
Detailed Description
informed consent taken, study was a prospective cohort study, with controlled group a retrospectively. patients ablated by total thyroidectomy only who failed to achieve ablation with the first dose of iodine 131I may be dynamically risk stratified as high-risk category and managed aggressively. N0 patients will benefit and ablated by total thyroidectomy and prophylactic central neck dissection, PCND decreases the residual, increase the RFS and patients without residual do not need adjuvant RAI therapy except in high risk group. Histological grading, size of the primary tumour, the extension of PTC, the extent of surgery were found to be a strong predicting factor for recurrence-free survival
Locoregional recurrence cases always found more in male patients aged more than 45 years old. Size of the primary tumour and the extent of surgery was a significant factor for RFS,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Carcinoma
Keywords
papillary carcinoma, recurrence of PTC, Radio-iodine therapy for PTC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
prospective cohort study
Masking
ParticipantInvestigator
Masking Description
guuartor of study, only participant
Allocation
Randomized
Enrollment
199 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comparison between the studied groups regarding management.
Arm Type
Active Comparator
Arm Description
The postoperative RAI scan after 1 month, showed a positive residual tumour in lateral LN in 70 patients in the controlled group and 13 patients in Group II, 8 patients in group III. In group I, Patients with residuals were submitted to RAI ablation.
Arm Title
Recurrence free survival
Arm Type
Other
Arm Description
patients with total thyroidectomy only had shorter recurrence free survival
Intervention Type
Procedure
Intervention Name(s)
Total thyroidectomy and central neck dissection
Primary Outcome Measure Information:
Title
recurrence free survival
Description
recurrence free survival calculated from first day of diagnosis
Time Frame
21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥20 years, Histopathology proved PTC, with no lymph nodes detected (N0)
Exclusion Criteria:
Younger age ≤20 years. Prior thyroidectomy, previous radiation exposure, postoperative radioactive iodine therapy, Histopathology report of any type of malignancy other than PTC or patients did not complete their postoperative follow-up period. PTC With N1 or N2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassem M Sieda
Email
drbassemmostafa@yahoo.com
Facility Information:
Facility Name
Zagazig University Hospitals
City
Zagazig
ZIP/Postal Code
13
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassem M Sieda, phd
Phone
00966541900039
Email
drbassemmostafa@yahoo.com
First Name & Middle Initial & Last Name & Degree
Bassem M Sieda
Email
drbassemmostafa@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
after aprovel, recommendation of study will be shared with other researchers
IPD Sharing Time Frame
1 year
Citations:
PubMed Identifier
25590215
Citation
Viola D, Materazzi G, Valerio L, Molinaro E, Agate L, Faviana P, Seccia V, Sensi E, Romei C, Piaggi P, Torregrossa L, Sellari-Franceschini S, Basolo F, Vitti P, Elisei R, Miccoli P. Prophylactic central compartment lymph node dissection in papillary thyroid carcinoma: clinical implications derived from the first prospective randomized controlled single institution study. J Clin Endocrinol Metab. 2015 Apr;100(4):1316-24. doi: 10.1210/jc.2014-3825. Epub 2015 Jan 15.
Results Reference
result
PubMed Identifier
29750323
Citation
Kim K, Kim JH, Park IS, Rho YS, Kwon GH, Lee DJ. The Updated AJCC/TNM Staging System for Papillary Thyroid Cancer (8th Edition): From the Perspective of Genomic Analysis. World J Surg. 2018 Nov;42(11):3624-3631. doi: 10.1007/s00268-018-4662-2.
Results Reference
result
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Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
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