Screening and diagnosis of primary aldosteronism. Consensus document of all the Spanish Societies involved in the management of primary aldosteronism.

Primary aldosteronism (PA) is the most frequent cause of secondary hypertension (HT), and is associated with a higher cardiometabolic risk than essential HT. However, PA remains underdiagnosed, probably due to several difficulties clinicians usually find in performing its diagnosis and subtype classification. The aim of this consensus is to provide practical recommendations focused on the prevalence and the diagnosis of PA and the clinical implications of aldosterone excess, from a multidisciplinary perspective, in a nominal group consensus approach by experts from the Spanish Society of Endocrinology and Nutrition (SEEN), Spanish Society of Cardiology (SEC), Spanish Society of Nephrology (SEN), Spanish Society of Internal Medicine (SEMI), Spanish Radiology Society (SERAM), Spanish Society of Vascular and Interventional Radiology (SERVEI), Spanish Society of Laboratory Medicine (SEQC(ML)), Spanish Society of Anatomic-Pathology, Spanish Association of Surgeons (AEC).

Practical consensus for the treatment and follow-up of primary aldosteronism: a multidisciplinary consensus document.

Primary aldosteronism (PA) is the most frequent cause of secondary hypertension and is associated with a higher cardiometabolic risk than essential hypertension. The aim of this consensus is to provide practical clinical recommendations for its surgical and medical treatment, pathology study and biochemical and clinical follow-up, as well as for the approach in special situations like advanced age, pregnancy and chronic kidney disease, from a multidisciplinary perspective, in a nominal group consensus approach of experts from the Spanish Society of Endocrinology and Nutrition (SEEN), Spanish Society of Cardiology (SEC), Spanish Society of Nephrology (SEN), Spanish Society of Internal Medicine (SEMI), Spanish Radiology Society (SERAM), Spanish Society of Vascular and Interventional Radiology (SERVEI), Spanish Society of Laboratory Medicine (SEQC(ML)), Spanish Society of Anatomic-Pathology and Spanish Association of Surgeons (AEC).

Protocolization of multicenter clinical studies in the digital era. Is useful data centralization by a data-manager?

INTRODUCTION: In multicenter studies, the protocolization of data is a critical phase that can generate biases.The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data -manager. METHODS: National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (a) center of origin; and (b) centralized by a data manager: The concordance between the data is analyzed for the global data and for the two groups of the project: (a) study group (Familiar carcinoma, 30 researchers protocolize); (b) control group (Sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. RESULTS: The study includes a total of 689 patients with carcinoma, 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa = 0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa = 0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa = 0.922). Also, 4.6% of transcription errors were detected. CONCLUSIONS: In multicenter clinical studies, the centralized data protocolization o by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin.

Surgical resources in advanced thyroid cancer treatment with aerodigestive tract invasion.

BACKGROUND: Despite papillary thyroid cancer (PTC) excellent prognosis, 10-15% of patients may present aggressive local behaviour. We present two cases with different aerodigestive tract invasion partners in which two reconstructions were used, out of all the surgical resources we have planned preoperatively [1-4]. METHODS: Case 1: 57-year-old woman with asymmetric goitre and a 60mm nodule (Bethesda-VI). CT showed suspected involvement of aero-digestive tract. Endobronchial ultrasound (EBUS) showed no tracheal invasion. Per oral endoscopic-US confirmed transmural oesophageal involvement. Surgery included total thyroidectomy(left recurrent laryngeal nerve was sacrificed), bilateral central and left lateral lymph node dissection, oesophageal partial resection and reconstruction with free radial flap. Case 2: 75-year-old male with cervical mass and haemoptysis. US showed a 62 mm nodule (Bethesda-VI). PET-CT showed tracheal invasion(bronchoscopy confirmatory). Per oral endoscopic-US showed no transmural oesophageal involvement. Surgery included total thyroidectomy (right recurrent laryngeal nerve was sacrificed), bilateral central lymph node dissection, tracheal resection and extra-mucosal oesophageal resection. RESULTS: First patient required tracheostomy. She presented a self-limiting salivary fistula. She was discharged after 6 weeks with good oral intake and tracheostomy closed. Pathology report showed multifocal papillary thyroid cancer(tall cells, 70mm),micro-metastatic lymph node involvement. Afterwards, radioiodine ablation was performed. Six months after surgery there was no evidence of structural disease and analysis showed Tg 1 µg/L. Second patient developed nosocomial pneumonia and was discharged after 3 weeks. Pathology report showed papillary thyroid cancer (insular growth, 52 mm), bilateral neck central lymph nodes involvement, transmural tracheal infiltration, free margins. Radioiodine ablation is pending. CONCLUSIONS: Surgical treatment of advanced/invasive PTC offers good results in terms of survival and quality of life. Adequate pre-surgical planning, which includes multiple surgical resources, and a multidisciplinary team approach are required.

Vitamin D Deficiency Reduces Postthyroidectomy Protracted Hypoparathyroidism Risk. Is Gland Preconditioning Possible?

Context: Hypoparathyroidism is the most frequent complication after total thyroidectomy (PT-hypoPTH). After 1 year, most patients recover parathyroid function; however, the implicated physiologic dynamics remain unknown. Vitamin D deficiency (VDD) is the main cause of secondary hyperparathyroidism. Whether this compensatory hyperparathyroidism could influence parathyroid function recovery (PFR) in the setting of PT-hypoPTH has not been studied. Objective: This work aimed to evaluate the effect of preoperative VDD on PFR. Methods: A retrospective study was conducted with a prospectively maintained database including patients undergoing a total thyroidectomy between May 2014 and June 2019. Preoperative vitamin D (25(OH)D) less than 20 mg/mL was defined as VDD. Intact PTH less than 14 pg/mL on postoperative day 1 was defined as PT-hypoPTH. Transient PT-hypoPTH displayed PFR within the first year (early recovery: < 30 days; protracted recovery: > 30 days) whereas definite PT-hypoPTH did not. Survival analysis evaluated the effect of preoperative VDD on PFR, and a binary logistic regression model identified associated factors. Results: A total of 397 patients were identified. The observed rates of transient, protracted, and definite PT-hypoPTH were 32.9%, 15.1%, and 5.2%, respectively. Rates of VDD were higher in the early-recovery PT-hypoPTH group (55.2% vs 31.5%; P = .01). Preoperative VDD was associated with faster PFR (19 vs 35 days; P = .03) and behaved as a protective factor for protracted PT-hypoPTH (odds ratio 0.47; 95% CI, 0.25-0.881; P = .016) in the multivariable analysis. Conclusion: Preoperative VDD could act as a preconditioning factor of the parathyroid glands prior to the surgical aggression exerted against them during surgery aiding PFR. Basic research studies and prospective clinical trials are needed to explain the underlying physiological mechanisms and to provide further evidence to improve clinical management.

When is it worth performing lymphadenectomy in patients with melanoma micrometastases? A 20-year experience retrospective analysis.

INTRODUCCIÓN: Actualmente existe controversia respecto a los beneficios de realizar linfadenectomía en pacientes de melanoma con una biopsia selectiva de ganglio centinela (BSGC) positiva. La carga tumoral > 1 mm se ha propuesto como el parámetro mas relevante asociado a una linfadenectomía positiva y un deterioro de la supervivencia libre de enfermedad. MATERIAL Y MÉTODOS: Se analizaron los datos de 119 pacientes de melanoma con BSGC positiva atendidos en el periodo entre Junio de 1997 y Junio de 2017. Los pacientes se clasificaron según la carga tumoral en dos grupos: ≤ 1 mm and > 1 mm. RESULTADOS: La linfadenectomía resultó positiva en sólo 6 (10%) pacientes con una carga tumoral ≤ 1 mm, y en 23 (37.7%) pacientes con carga tumoral > 1 mm (p < 0.001). En análisis univariante, la carga tumoral fue el único factor predictivo de linfadenectomía positiva (OR 5.24 (1.94-14.13)). En análisis multivariante, la carga tumoral fue la única variable independiente de supervivencia específica de melanoma (SEM). CONCLUSION: Aunque la realización de linfadenectomía debe individualizarse en cada caso, la carga tumoral > 1 mm puede ser un factor predictivo de la presencia de ganglios no centinelas positivos en piezas de linfadenectomía, y un factor pronostico independiente importante para la SEM. BACKGROUND: The benefits of complete lymph node dissection (CLND) in melanoma patients with a positive sentinel lymph node biopsy (SLNB) have been recently questioned. Sentinel node (SN) tumor burden > 1 mm has been proposed as the most reliable parameter associated with positive CLND and poorer disease-free survival. MATERIAL AND METHODS: Between June 1997 and June 2017, data from 119 melanoma patients with positive SLNB were analyzed. Patients were classified by SN burden in two groups: ≤ 1 mm and > 1 mm. RESULTS: CLND was positive in 6 (10%) patients with SN tumor burden ≤ 1 mm and in 23 (37.7%) patients with > 1 mm (p < 0.001). In univariable analysis, SN tumor burden was the only predictive factor of positive CLND (OR 5.24 [1.94-14.13]). In multivariable analysis, SN tumor burden was the only independent factor of melanoma-specific survival (MSS). CONCLUSION: Although CLND should still be considered individually in patients with positive SLNB, SN tumor burden >1 mm might be a good predictive factor of additional positive non-sentinel nodes and a strong independent prognostic factor in melanoma-specific survival.

Efficacy and safety of preoperative preparation with Lugol's iodine solution in euthyroid patients with Graves' disease (LIGRADIS Trial): Study protocol for a multicenter randomized trial.

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.

Scarless neck thyroidectomy using bilateral axillo-breast approach: Initial impressions after introduction in a specialized unit and a review of the literature. / Tiroidectomía sin incisión cervical por abordaje endoscópico biaxilo-biareolar. Primeras impresiones tras su introducción en una unidad especializada. Revisión de la literatura.

INTRODUCTION: The extracervical approach for thyroidectomy remains widely unknown in our country. Its main aim is to avoid a cervical scar while maintaining the same safety profile of conventional thyroidectomy. The objective is to communicate our experience after the first 15 cases using the endoscopic bilateral axillo-breast approach (BABA) and to review critical points described in literature. METHODS: Between June 2017 and June 2018, 15 endoscopic thyroidectomies were performed using the BABA extracervical approach, locating incisions in axillary folds and areolar borders. Indications were benign goiter and suspicious nodule (Bethesda 3 and 4). RESULTS: All 15 cases (12 patients) were treated using the extracervical endoscopic technique. We performed 5 total thyroidectomies, 7 hemithyroidectomies and 3 completion thyroidectomies. Mean surgical time for total thyroidectomy was 285minutes and 210minutes for hemithyroidectomy. The average hospital stay was 1.67days. With a mean follow-up of 7.73months, rates of transient and definitive hypoparathyroidism were 37% and 0%, and transient recurrent nerve palsy occurred in one case. Anterior chest paraesthesia rate was 80%, which were mild and resolved within the first month. The degree of cosmetic satisfaction is very high. CONCLUSION: Our experience with endoscopic bilateral axillo-breast approach thyroidectomy is short but satisfactory. It is a reproducible procedure that requires extensive experience in endocrine and endoscopic surgery. Extracervical approaches are an alternative for selected patients who are especially concerned about cervical scarring and are not intended to displace conventional thyroidectomy, which is the current gold standard. Our Scientific Society should explore these approaches to establish coherent indications and limitations.

[Adjustable gastric band as surgical treatment for morbid obesity. Are worldwide results reproducibles in Spain?]. / La banda gástrica ajustable como tratamiento de la obesidad mórbida: ¿son reproducibles los resultados mundiales en España? Análisis de 132 pacientes intervenidos en los últimos 10 años.

INTRODUCTION: Adjustable gastric banding is a surgical technique used all over the world for the treatment of morbid obesity. In Spain, the number of patients treated with adjustable gastric banding is far lower than the average worldwide average. A number of reasons have been put forward to explain this difference. MATERIAL AND METHODS: A program of bariatric surgery by means of implantation of an adjustable gastric banding was started in 2001, together with a dedicated follow-up protocol in order to prevent complications and improve results. RESULTS: A total of 132 patients were operated on between 2001 and 2011. The mean age of the 102 female and 30 male patients was 39 years, and the mean body mass index was 43. Follow-up was longer than 5 years in 61 patients, while the mean follow-up in the rest was 44.4 months. There was no mortality or severe morbidity. Eight patients (6.06%) underwent reoperation, 3 of them for complications related to the reservoir, 4 for slipping of the band, and one for erosion. One slipped band was removed, and a new one (of the Lap Band type) was inserted. Three slipping bands were converted to other techniques. The percentage excessive body weight loss was maintained in 54.8% of the patients followed-up for longer than 5 years. CONCLUSIONS: The results of our series are comparable to those reported in the literature and show that, provided that a close follow-up, like that performed by most groups, is implemented, adjustable gastric banding can also be a safe and effective bariatric surgery technique in our country.

[Use of the round ligament in the repair of large bile duct defects in type II Mirizzi's syndrome]. / Utilización del ligamento redondo en la reparación de defectos amplios de la vía biliar en el síndrome de Mirizzi de tipo II.

Mirizzi's syndrome is a rare complication of cholelithiasis, and type II (cholecystocholedochal fistula) can be a technical challenge due to inflammation and the biliary duct defect. We report two cases that were treated with a simple and little known technique that uses the round ligament as a plasty to seal the large bile duct defect.