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| ID | Type | Description | Link |
|---|---|---|---|
| 2017/2581 | Other Identifier | CSET number |
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Prospective randomized open phase III non-inferiority trial in cT1bT2N0 papillary thyroid carcinoma comparing: total thyroidectomy alone (experimental group) versus total thyroidectomy + Prophylactic Neck Dissection PND (reference group).
Pre-registered patients will be randomized before surgery for tumors with class-6 cytology (Bethesda) or in the operating room after confirmation of malignancy by frozen section analysis for tumors with class-5 cytology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection as defined by the American Thyroid Association [American Thyroid Association Surgery Working Group, Thyroid 2009]. This is a standard treatment recognized by the French Society of Otolaryngology Head and Neck Surgery [French Society of Otolaryngology Head and Neck Sugery]. |
|
| Group 2 | Experimental | total thyroidectomy alone without neck dissection. This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection | Procedure | total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection as defined by the American Thyroid Association [American Thyroid Association Surgery Working Group, Thyroid 2009]. This is a standard treatment recognized by the French Society of Otolaryngology Head and Neck Surgery [French Society of Otolaryngology Head and Neck Sugery]. - The number of lymph nodes resected, the number of metastatic nodes, their size and the presence or absence of extranodal spread will be recorded. Due to the large natural variability of the number of lymph nodes retrieved in a prophylactic neck dissection [Hartl DM, Ann Surg 2012], no patient will be excluded on the basis of number of lymph nodes. Furthermore, the participating surgeons routinely perform complete central neck dissections, and were chosen to participate in this study due to a homogenous technique among these surgeons [Hartl DM, World J Surg 2012]. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients in complete remission | 1 year after randomization |
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Inclusion Criteria:
Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2)
cN0: absence of lymph nodes suspicious for malignancy on pre- operative ultrasound performed by the center's designated radiologist according to a standardized report
Absence of a medical contra indication to performing a total thyroidectomy with or without bilateral prophylactic neck dissection of the central compartment
Women of childbearing potential should have a negative pregnancy test (serum or urine) before any radioiodine administration. Sexually active patients must agree to use an effective method of contraception or to abstain from sexual activity during the study and for at least 6 months after last dose of radioiodine.
Patient affiliated to a social security regimen or beneficiary of such regimen
Patients age ≥ 18 years old, french-speaking
Patients should understand, sign and date the written informed consent form prior to any protocol specific procedures. Patients should be able and willing to comply with study visits.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Villejuif | Val de Marne | 94805 | France | ||
| CHU d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37118818 | Derived | Hartl D, Godbert Y, Carrat X, Bardet S, Lasne-Cardon A, Vera P, Ilies E, Zerdoud S, Sarini J, Zalzali M, La Manna L, Schneegans O, Kelly A, Kauffmann P, Rodien P, Brunaud L, Grunenwald S, Housseau E, Laghouati S, Bouvet N, Lecerf E, Hadoux J, Lamartina L, Schlumberger M, Borget I. ESTIMation of the ABiLity of prophylactic central compartment neck dissection to modify outcomes in low-risk differentiated thyroid cancer: a prospective randomized trial. Trials. 2023 Apr 28;24(1):298. doi: 10.1186/s13063-023-07294-0. |
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Two parallel groups randomized 1:1 to total thyroidectomy alone or total thyroidectomy with bilateral prophylactic central neck dissection, followed by standardized radioactive iodine ablation and scheduled follow-up assessments.
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|
| total thyroidectomy alone without neck dissection | Procedure | This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery |
|
| Angers |
| 49000 |
| France |
| Hôpital Saint André | Bordeaux | 33000 | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| Groupement Hospitalier Est | Bron | 69677 | France |
| Centre François Baclesse | Caen | 14 000 | France |
| Jean Perrin | Clermont-Ferrand | 63 011 | France |
| Centre Georges François Leclerc | Dijon | 21 079 | France |
| CH de Haguenau | Haguenau | 67500 | France |
| CHU Lille, Hôpital Claude Huriez | Lille | 59057 | France |
| CHU Nimes | Nîmes | 30029 | France |
| CHU de Poitiers | Poitiers | 86 021 | France |
| CHU Reims - Hôpital Robert Debré | Reims | 51 100 | France |
| Institut Godinot | Reims | 51 100 | France |
| Centre Henri Becquerel | Rouen | 76 000 | France |
| Institut de Cancérologie Strasbourg | Strasbourg | 67200 | France |
| Institut Claudius Régaud | Toulouse | 31059 | France |
| CHU de Toulouse Hôpital Larrey | Toulouse | 31400 | France |
| CHRU Nancy - Hôpitaux de Brabois | Vandœuvre-lès-Nancy | 24511 | France |
| CHU de Pointe à Pitre | Les Abymes | 97139 | Guadeloupe |
| Clinique Saint Vincent | Réunion | 97404 | Reunion |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D037981 | Neck Dissection |
| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
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