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2.
Contemp Clin Trials Commun ; 22: 100806, 2021 Jun.
Article in English | MEDLINE | ID: mdl-34195471

ABSTRACT

BACKGROUND: Currently, both the American Thyroid Association and the European Thyroid Association recommend preoperative preparation with Lugol's Solution (LS) for patients undergoing thyroidectomy for Graves' Disease (GD), but their recommendations are based on low-quality evidence. The LIGRADIS trial aims to provide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidectomy for GD. METHODS: A multicenter randomized controlled trial will be performed. Patients ≥18 years of age, diagnosed with GD, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy will be eligible for inclusion. Exclusion criteria will be prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery.Between January 2020 and January 2022, 270 patients will be randomized for either receiving or not preoperative preparation with LS. Researchers will be blinded to treatment assignment. The primary outcome will be the rate of postoperative complications: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death. Secondary outcomes will be intraoperative events (Thyroidectomy Difficulty Scale score, blood loss, recurrent laryngeal nerve neuromonitoring signal loss), operative time, postoperative length of stay, hospital readmissions, permanent complications and adverse events associated to LS. CONCLUSIONS: There is no conclusive evidence supporting the benefits of preoperative treatment with LS in this setting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03980132.

8.
Hum Pathol ; 48: 132-41, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26614398

ABSTRACT

Tumor resection in papillary thyroid carcinoma (PTC) is often accompanied by lymph node (LN) removal of the central and lateral cervical compartments. One-step nucleic acid amplification (OSNA) is a polymerase chain reaction-based technique that quantifies cytokeratin 19 (CK19) messenger RNA copies. Our aim is to assess the value of OSNA in detection of LN metastases in PTC, in comparison with imprints and microscopic analysis of formalin-fixed, paraffin-embedded (FFPE) tissue. A total of 387 LNs from 37 patients were studied. From each half LN, 2 imprints were taken and analyzed with hematoxylin and eosin (H&E) and CK19 immunostaining. One half of the LN was submitted to OSNA and one half to FFPE processing and H&E and CK19 staining. For concordance analysis, every single LN was considered as a case. A group of 11 cases with discordant results between OSNA and H&E/CK19 FFPE sections were subjected to additional FFPE serial sectioning and H&E and CK19 staining. We found a high degree of concordance between the assays used, with sensitivities ranging from 0.81 to 0.95, and specificities ranging from 0.87 and 0.98. OSNA allowed upstaging of patients from pN0 to pN1, in comparison with standard pathologic analysis. Identification of a metastatic LN with more than 15000 CK19 messenger RNA copies predicted the presence of a second LN with macrometastasis (<5000 copies). In summary, the study shows that OSNA application in sentinel or suspicious LN may be helpful in assessing nodal status in PTC patients.


Subject(s)
Carcinoma/pathology , Keratin-19/analysis , Lymphatic Metastasis/diagnosis , Neoplasm Staging/methods , Polymerase Chain Reaction/methods , Thyroid Neoplasms/pathology , Area Under Curve , Biomarkers, Tumor/analysis , Carcinoma, Papillary , Humans , Paraffin Embedding , ROC Curve , Sensitivity and Specificity , Staining and Labeling , Thyroid Cancer, Papillary
11.
Gland Surg ; 4(1): 8-18, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25713775

ABSTRACT

BACKGROUND: According to some authors, routine preoperative laryngoscopy should be the standard of care in all patients undergoing thyroid surgery. The rationale for this approach is (I) the risk that a patient has a preoperative vocal cord palsy (VCP) without symptoms; (II) the presence of VCP preoperatively is suggestive of invasive malignancy; (III) it is relevant for the use of intraoperative nerve monitoring; and (IV) surgical strategy may be better defined if a paralysed vocal cord is detected preoperatively. METHODS: This is a review of studies of patients who underwent routine preoperative laryngoscopy to anticipate preoperative VCP and that evaluated related risk factors, including previous surgery, voice function complaints, and a diagnosis of malignancy. The estimated risk of sustaining preoperative VCF in the absence of these factors was determined. The relevant current guidelines from different professional bodies are also addressed. RESULTS: The level of evidence that supports routine preoperative laryngoscopy is weak. The risk of harboring preoperative VCP in the absence of previous neck or other risk-related surgery, advanced malignancy or voice symptoms is very low (0.5% of cases). CONCLUSIONS: Selective rather than routine use of preoperative laryngoscopy may be acceptable provided that the risk of undetected paralysis is as low as can be reasonably ascertained from the available literature.

15.
Langenbecks Arch Surg ; 398(3): 419-22, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23129175

ABSTRACT

PURPOSE: The aim of our study was to analyze the relationship between surgeon volume and morbidity in patients operated on by surgeons with endocrine specialization (EndS group) and those operated on by general surgeons (GenS group) in a single tertiary institution. METHODS: We present the results of a prospective cohort study of all patients undergoing thyroid surgery in our institution between January 2008 and January 2010, all of whom attended for follow-up for at least 12 months. We assessed pre- and postoperative recurrent laryngeal nerve (RLN) function by laryngoscopy. We monitored serum calcium concentrations in all patients until these values were normal without vitamin D and oral calcium supplementation. RESULTS: We studied 225 patients: 30 in the GenS group (six surgeons performing <5 procedures per surgeon per year) and 195 in the EndS group (two surgeons performing >40 procedures per surgeon per year). The total number of exposed RLN was 46 and 325, respectively. The incidence of RLN palsy persisting beyond 12 months was higher in the GenS group (2/46 vs. 1/325 exposed RLNs, p = 0.04). The incidence of hypocalcaemia persisting beyond 12 months (bilateral procedures) was also higher in the GenS group (3/16 vs. 3/130 patients, p = 0.028). CONCLUSIONS: Morbidity in terms of permanent RLN palsy and hypocalcaemia was less frequent among patients operated on by endocrine-dedicated surgeons. Differences in surgical volume and specialized training in neck endocrine surgery may explain these variations in morbidity.


Subject(s)
Endocrine Surgical Procedures/adverse effects , Hypocalcemia/epidemiology , Recurrent Laryngeal Nerve Injuries/epidemiology , Thyroid Gland/surgery , Thyroidectomy/adverse effects , Workload/statistics & numerical data , Clinical Competence , Cohort Studies , Endocrine Surgical Procedures/methods , Female , General Surgery , Humans , Hypocalcemia/etiology , Hypocalcemia/physiopathology , Laryngoscopy/methods , Male , Outcome Assessment, Health Care , Postoperative Complications/epidemiology , Postoperative Complications/physiopathology , Practice Patterns, Physicians' , Prospective Studies , Quality Control , Recurrent Laryngeal Nerve Injuries/etiology , Thyroid Gland/physiopathology , Thyroidectomy/methods , Treatment Outcome
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