Non-inferiority will be demonstrated if the rate of patients in complete remission at 1 year after randomization does not differ by more than L=5%. What is the CPT code for selective neck dissections? The primary objective of this study is to assess the non-inferiority of total thyroidectomy alone as compared to total thyroidectomy with bilateral prophylactic central compartment neck dissection in terms of the rate of complete remission (excellent response) at 1 year after randomization, for differentiated thyroid cancer cT1bT2N0. Article The final pathology results showed papillary thyroid cancer. Since the thyroid has only two lobes (one on each side), if both lobes were removed (bilateral), I would use 60240. The requirement of thyroidectomy during Total Laryngectomy is controversial. Data collected will be managed in the Biostatistics and Epidemiology unit at Gustave Roussy. This code includes reimbursement for the thyroidectomy and the limited dissection. What codes should be assigned for the total thyroidectomy with the central neck dissection and the parathyroid reimplantation? 2008;158(4):55160. However, it is the, Copyright 2023 TipsFolder.com | Powered by Astra WordPress Theme. The data management team at the promotor site is certified by the French National Cancer Institut (Centre de Traitement de Donnes CTD, Institut National du Cancer). MS: study conception and oversight. Randomization will be performed online or by fax with the Trial Master program. Patient will be considered as evaluable if the treatment and the follow-up conform to the study protocol (diagnostic tests performed) and if the patient does not have detectable anti-Tg antibodies. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with a trial procedure. Total thyroid lobectomy, unilateral; with or without isthmusectomy. Those in favor of PND for whom it is a standard of care cite the low-level evidence suggesting, Improved recurrence-free survival (retrospective case series), [1,2,3], A higher rate of recurrence in the presence of lymph node metastases (in some retrospective studies) and the usefulness of a complete staging in the neck to stratify for radioactive iodine treatment, [4, 5], The technical difficulty of performing a reintervention in the central compartment secondarily, and, The absence of increased permanent complications of PND (in experienced hands). The thyroid is approached (meaning the surgeon gains access to the thyroid) through an incision in the neck. Ann Surg Oncol. government site. However, we are not sure if the central neck dissection would be considered a bilateral procedure. Background and Objectives: Recently, the single-port (SP) robotic system was introduced for minimally invasive operative techniques. Study record managers: refer to the Data Element Definitions if submitting registration or results information.. Search for terms Clipboard, Search History, and several other advanced features are temporarily unavailable. ICD-10-CM is a billable/specific code that can be used for reimbursement purposes to indicate a diagnosis. The coordinating center is located at the promotors site. World J Surg. All patients will have a postoperative visit within 4 months of the surgery with the surgeon to record post-op complications. 60500 . Tisell LE, Nilsson B, Mlne J, et al. Cardiothoracic SurgeryDiagnostic & Interventional CardiovascularDiagnostic RadiologyInterventional RadiologyPain ManagementVascular & Endovascular Surgery. Setting the significance level at 0.025 (one-sided) and a power of 80% requires a sample size of 598 patients without Tg antibodies (299 per group) (Nquery software). %PDF-1.7 Accessibility Working alone is not illegal, and it is perfectly safe in many cases. - Appendix 13 of the E. U. Disclaimer. The trial results will be published by the promotor team in a peer-reviewed medical journal. Anatomical Considerations. A fax or an internet access in the operating room or at proximity is then mandatory. If non-inferiority is demonstrated with this high-level evidence, prophylactic neck dissection will have been shown to not be necessary in clinically low-risk papillary thyroid carcinoma. Leplege A, Ecosse E, Verdier A, Perneger TV. Central neck lymph node dissection for papillary thyroid cancer: comparison of complication and recurrence rates in 295 initial dissections and reoperations. Amendments will be communicated directly by the promotor to the participating centers who will, if applicable, inform trial participants. Unauthorized use of these marks is strictly prohibited. Google Scholar. Google Scholar. The number of lymph nodes resected, the number of metastatic nodes, their size, and the presence or absence of extranodal spread will be recorded. Discover how to save hours each week. 2013;63(1):1130. Copyright 2023 Absolute Medical Coding Institute - All rights reserved. Koimtzis G, Stefanopoulos L, Alexandrou V, Tteralli N, Brooker V, Alawad AA, Carrington-Windo E, Karakasis N, Geropoulos G, Papavramidis T. Cancers (Basel). For this reason, diligence in collecting as much verifiable and reliable information is needed: both quality and timeliness are key factors. Privacy Policy | Terms & Conditions | Contact Us. World J Surg. Brierley J, Gospodarowicz M, Wittekind C. TNM Classification of Malignant Tumors. 2016;103(3):21825. Surgery. YG, XC, SB, AL-C, PV, EI, SZ, JS, MZ, LLM, OS, AK, PK, PR, LB, SG, EH: Trial co-investigators. Enjoy a guided tour of FindACode's many features and tools. The pharmacovigilance unit at Gustave Roussy will issue once a year throughout the clinical trial, or on request, the annual safety report (ASR) of the study. A vertical incision opens the midline between the strap muscles, from the thyroid notch to the sternal notch. An adverse event (AE) is any untoward medical occurrence in a patient that does not necessarily have a causal relationship with the study intervention/procedure (thyroidectomy, neck dissection, radioiodine, and rhTSH administration). 1 0 obj 2 What is the CPT code for total thyroidectomy with central neck dissection? 2022;171(1):1829. In this report, we have used the SPIRIT reporting guidelines [54]. How would a completion right thyroidectomy with central lymph node dissection be correctly reported? In any case, every effort will be made to document the patient outcome and all attemps should be documented in the corresponding medical file. Finally, the 2012 guidelines from the French Society of Otolaryngology Head and Neck Surgery recommend systematic PND [15]. 60271 cervical approachThe procedure involves surgical removal of the thyroid gland, including its extension into the thorax below the sternum. Lymph Node Dissection. Roh JL, Park JY, Rha KS, Park CI. The protocol used will be similar to the one used in ESTIMABL 1 trial and recently published in the Journal of Clinical Oncology [Borget I et al 2015]. If the physician performs a parathyroidectomy during a thyroidectomy, do not separately report the parathyroidectomy because 60500, 60502 and 60505 are usually considered incidental to a thyroidectomy. Ann Surg Oncol. For example, suppose an otolaryngologist removes both thyroid lobes. Zhao W, You L, Hou X, Chen S, Ren X, Chen G, et al. Results of the long-term follow-up might be available in medical publication format after availability of the Clinical Study Report. Total Thyroidectomy with Central Neck Dissection. The current protocol is version 2.3, October 22, 2021.The estimated completion date for the primary endpoint is June 2026. We aim to demonstrate the non-inferiority of thyroidectomy alone as compared to total thyroidectomy with prophylactic central neck dissection in conjunction with adjuvant RAI 30 mCi with rTSH stimulation in terms of excellent response at 1 year. The surrogate endpoint in the present study is the rate of excellent response as defined by the ATA,[13] or complete remission, at 1 year. Preoperative Prediction of Central Cervical Lymph Node Metastasis in Fine-Needle Aspiration Reporting Suspicious Papillary Thyroid Cancer or Papillary Thyroid Cancer Without Lateral Neck Metastasis. Radical neck dissection. 2007 Oct. 29(10):901-6. Article 60252 -Thyroidectomy, subtotal or total for malignancy, with limited neck dissection.Code represents a total thyroidectomy with limited lymph node dissection. The Biostatistics and Epidemiology unit at Gustave Roussy will implement electronic CRF (eCRF) using adequate software, thus allowing safe online direct data collection. In some situations, however, the coder may not be able to find a single code that covers both procedures that the surgeon performs. Hartl DM, Mamelle E, Borget I, Leboulleux S, Mirghani H, Schlumberger M. Influence of prophylactic neck dissection on rate of retreatment for papillary thyroid carcinoma. Patient has papillary thyroid carcinoma and presents for a total thyroidectomy with central neck dissection, reimplantation of parathyroid into the strap muscle, direct and flexible laryngoscopies were performed at the beginning and end of the surgery, and bilateral cranial nerve EMG monitoring tubes. We aim to demonstrate the non-inferiority of thyroidectomy . Gastroenterol Clin Biol. At 1, 3, and 5 years after randomization: Quality of life (SF36 + EuroQol EQ-5D), Anxiety (State-Trait Anxiety Inventory-STAI) [47,48,49]. Silaghi H, Lozovanu V, Georgescu CE, Pop C, Nasui BA, Ctoi AF, Silaghi CA. Int J Endocrinol. Dismiss. From the jawbone to the collarbone, all of the tissue on the side of the neck has been removed. Tarifs of the General Nomenclature of Professional acts (NGAP), the Common Classification of Medical Acts (CCAM) will be used. Thyroid nodule measuring 1140 mm on ultrasound (cT1bT2), AND with fine-needle aspiration biopsy (FNAB) cytology in favor of papillary thyroid carcinoma (Type 6 according to the Bethesda classification (Appendix 2), OR with FNAB cytology suspicious for malignancy (Type 5 according to the Bethesda classification). Khaldoun E, Woisard V, Verin E. Validation in French of the SWAL-QOL scale in patients with oropharyngeal dysphagia. The grant was allotted under the following number: INCa-DGOS-9823. Prophylactic central neck dissection in patients without detectable nodal disease remains a controversial topic due to a lack of definitive evidence of improved recurrence rates or survival and the possibility of higher complication rates compared to total thyroidectomy alone. Level Ib: Submandibular triangle. Ito Y, Onoda N, Okamoto T. The revised clinical practice guidelines on the management of thyroid tumors by the Japan Associations of Endocrine Surgeons: Core questions and recommendations for treatments of thyroid cancer. Resource consumption collected will concern the following direct medical costs for: Hospitalization for initial surgery, including the time in the operating room and for performing the surgery, Hospitalizations for management of complications (vocal fold paralysis, hypoparathyroidism), Hospitalizations for further treatments (surgery or iodine administration), Equipment, consultations, medical or paramedical acts for management of complications. Thyroid. Viola D, Materazzi G, Valerio L, Molinaro E, Agate L, Faviana P, et al. The clinical trial is conducted in conformity with: - Ethical principles stated in the Declaration of Helsinki 1964, as revised in Fortaleza, 2013, - The European Directive (2001/20/EC and 2005/28/EC), - Directive 95/46/CE on the processing of personal data. Clean and protect the wound. Can I buy a dress off the rack at Davids Bridal? The protocol used will be similar to the one used in ESTIMABL 1 trial and recently published in the Journal of Clinical Oncology [55]. Patients will be evaluated at 8 +/2 months post-iodine (814 months postoperatively or 1 year) then yearly with neck ultrasound, unstimulated ultrasensitive thyroglobulin (usTg/LT4), and anti-Tg antibodies. One entire thyroid lobe is removed including the isthmus, if performed. If our study confirms the non-inferiority of total thyroidectomy alone, prophylactic central compartment neck dissection could be abandoned for these low-risk patients without taking undue oncologic risks. The endpoint of 5 years reflects the data from a prospective multicenter study of 715 patients reporting that 81% of recurrences occurred within 5 years,[43] and from a retrospective study of 1020 patients followed for 10 years reporting that all structural recurrences occurred within 8 years, with 77% occurring within 5 years [44].