Gland and Hormone Related Diseases

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Neoplasms

Thyroid Diseases

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Thyroid Neoplasms

Thyroid Nodule

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Endocrine Gland Neoplasms

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Parathyroid Hormone

Thyroid lobectomy was performed with a standard technique of fine capsular en bloc dissection and resection, from inferior pole to superior pole. Superior parathyroid glands were identified and preserved in situ, inferior parathyroid glands were protected in situ or autotransplanted in the sternocleidomastoid muscle according to three certain types based on their blood supply and location. All the patients underwent lobectomy received ipsilateral therapic central compartment neck dissection. After the thyroid lobectomy, the contralateral benign thyroid nodule was treated with intraoperative thermal ablation. The "hydrodissection technique" was used during the ablation process to prevent recurrent laryngeal nerve, esophageal and other important structures from being destroyed by heat energy.

Thyroid lobectomy was performed with a standard technique of fine capsular en bloc dissection and resection, from inferior pole to superior pole. Superior parathyroid glands were identified and preserved in situ, inferior parathyroid glands were protected in situ or autotransplanted in the sternocleidomastoid muscle according to three certain types based on their blood supply and location. All the patients underwent lobectomy received ipsilateral therapic central compartment neck dissection.

After the thyroid lobectomy, the contralateral benign thyroid nodule was treated with intraoperative thermal ablation. The "hydrodissection technique'' was used during the ablation process to prevent recurrent laryngeal nerve, esophageal and other important structures from being destroyed by heat energy.

Intraoperative thermal ablation

Qianqian Yuan, M.D.

Qianqian Yuan, MD.

Gaosong Wu, Ph.D.

Recent trends in the management of patients with low-risk papillary thyroid carcinoma who have a nonsuspicious or cytologically benign contralateral nodule call into question the need for routine total thyroidectomy. Although the lobectomy for the unilateral thyroid cancer with contralateral benign nodules is sufficient treatment, some of the patients might suffer from the anxiety of the residual benign thyroid nodule and tend to choose total thyroidectomy, which might be overtreatment.

Thermal ablation has been proven to be effective in achieving nodule shrinkage and being also free from major complications. In our institution, intraoperative RFA was a proposed alternative strategy to treat the contralateral benign nodules after the thyroid lobectomy for the malignant lobe, which was found to have a better quality of life on anxiety, physiological health, social family, psychological and sensory mentions with a considerable complication rate.

Function Integrity of Neck Anatomy in Thyroid Surgery

Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial

Transient or persistent hypoparathyroidism confirmed by serum calcium levels was less than the lower limit at examination center and had symptoms of hypocalcemia. Postoperative vocal cord paralysis was defined as fixed vocal cord mobility with laryngofiberoscopic examination.

All patients were requested to answer the HADS questionnaire, the scores of which were recorded.

All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.

All patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.

Lymph node recurrence or distant recurrence

Wuhan University

Director

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Thyroiditis

Deglutition Disorders

Goiter

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Patients s/p post-thyroidectomy without complication

\*will NOT be enrolled to standard dysphagia-rehabilitation treatment

Patients s/p post-thyroidectomy with both dysphagia and other documented TT complication such as vocal cord paralysis/hypocalcemia/surgical site infection etc.

\*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.

Patients s/p post-thyroidectomy dysphagia only.

\*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.

DRT-diet modification, compensation strategies, oral motor exercises such as laryngeal elevation, masseters / tongue hold / exercise, bolus transition exercise; chin-down/up, head rotation, and other maneuvers with tactile stimulation.

Total thyroidectomy

Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS

Sema YUKSEKDAG, MD

Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS

Kadir M YILDIRAK, MD

The most common and feared complications of total thyroidectomy are vocal cord paralyses and hypocalcemia. However, post-thyroidectomy dysphagia is not uncommon and has important consequences on the quality of life (QoL). It should be taken seriously by all clinicians.

Dysphagia is a possible complication that can be observed in patients undergoing thyroidectomy, and can be related to superior and inferior laryngeal nerves dysfunction, but it usually appears after an uncomplicated surgical procedure. Aerodigestive symptoms, such as discomfort, tightness, lump, foreign body, difficulty or pain during swallowin, can also present before operation. If it appears or aggrevates after surgery, laryngeal nerve damage (superior laryngeal nerve - SLN, or inferior laryngeal nerve - recurrent, RLN), tracheo-malacia and postoperative fibrotic changes should be interrogated. However, in most of the cases, an anatomic and/or physiologic defect in the oro-pharngeal region is not easy to be detected. Therefore, a subjective feeling of dysphagia is more common.

Dysphagia has important consequences on the QoL in postoperative period, and should be addressed by the primary surgeon/clinician, regardless of whether it is objective or subjective.

The goal of the present study is to better understand the incidence of postoperative dysphagia symptoms among patients who have undergone total thyroidectomy for benign or malign thyroid disease. Besides, all possible risk factors (pre-intra-post-operative) are also going to be evaluated in detail, and the efficacy of a 6-week dysphagia-rehabilitation programme will also be employed and results will be shared.

Dysphagia among patients who have undergone total hyroidectomy for benign/malign thyroid disease. The preoperative factors (demographics; co-morbidities such as diabetes, multiple sclerosis, Parkinson's; body mass index; routine ear-nose-throat-ENT consultation), operative factors (over-manipulation, injury to larynx/neural plexus, easy/hard tracheal intubation, closure of strap muscles/stay open) and postoperative evaluation 1-No dysphagia, 2-Dysphagia with at least one other complication (nerve injury, hypocalcemia), 3-Dysphagia without any other surgical complications; ENT\&neurology consultations, survey.

THE STUDY IS OPEN TO ALL SURGICAL CLINICS OVER THE WORLD EAGER TO JOIN; EXCEL WITH FORMS TO BE FILLED ARE AVAILABLE, please contact the principle/co-investigators by phone/e-mail.

Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT

Pre-and Post-operative Risk Factors Affecting the Incidence and Severity of Dysphagia Following Total Thyroidectomy: An International Multi-centric Prospective Randomized Controlled Clinical Trial (RCT)

Excel documents including data (patient ID and protocol # will be shaded) available upon request

Subjective survey form to be filled- a self-evaluation questionnaire-to evaluate 'Change from baseline postoperative (po) day 1-3 to week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control.

assessing common dysphagia symptoms- includes 6 items scored within a range of 0 (without swallowing alterations) to 24 (maximum swallowing dysfunction).

Objective survey form to be filled- a clinician-oriented questionnaire assessing the swallowing function objectively, from stage I (normal function) to stage V (no oral intake). To evaluate change in dysphagia from baseline po day 1-3 to .po week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control.

Flexible fiberoptic laryngoscopy (any anatomic explanation for dysphagia? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).

EMG-electromyography test (any anatomic and/or physiologic dysfunction? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).

Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.

6-week treatment, starting from po week 6, for all patients with dysphagia- ending at po week 12. Any improvement after 6-week treatment? evaluate at po week 12 and please answer: Any improvent in dysphagia symptom? -YES or NO?

Umraniye Education and Research Hospital

Associated Professor of General Surgery and Surgical Oncology

CellFX Percutaneous Treatment under ultrasound guidance using nanosecond Pulse Field Ablation (nsPFA)

Percutaneous treatment with CellFX® Percutaneous Electrode using nanosecond pulse field ablation (nsPFA) technology

CellFX® Percutaneous Electrode (PE) System

William Knape

Melanie Vandegrift

Prof Stefano Spiezia, MD

The objective of this clinical feasibility study is to evaluate initial clinical safety and device performance of the CellFX Percutaneous Electrode (PE) System for the treatment of symptomatic benign thyroid nodules.

Cohort 1: (CellFX PE Procedure and Surgery) The first five enrolled subjects will be patients with planned thyroidectomy. The site investigator will perform the CellFX procedure followed by an ultrasound evaluation. The site investigator will then perform a partial or total thyroidectomy. Tissue samples from the CellFX targeted treated areas will be sent to the pathology lab for gross and histological evaluation. The participant will exit the study on the same day of surgery.

Cohort 2: (CellFX PE Procedure with 12 months follow-up) When Cohort 1 is completed, up to 25 subjects will undergo a CellFX treatment using a percutaneous approach under ultrasound guidance. After CellFX treatment, all subjects will be followed weekly until 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure.

CellFX ® Percutaneous Electrode (PE) Treatment of Benign Thyroid Nodules

First Clinical Feasibility Study Using the CellFX® Percutaneous Electrode (PE) System for the Treatment of Benign Thyroid Nodules

The primary safety endpoint will be assessed by the incidence of serious adverse device effects

Acute procedural success defined as a ≥ 50% nodule volume loss by ultrasonography and without serious adverse device effects within 6-months of the procedure

Pulse Biosciences, Inc.

Patients in the test group (120) will be treated with high intensity focused ultrasound (HIFU). The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms (VAS score).

Patients in the control group (120) will be actively observed and followed up. The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms (VAS score).

High-intensity focused ultrasound (HIFU) is a non-invasive, non-invasive treatment method. The principle is to focus high-intensity ultrasound on the target area. Energy is absorbed by the target tissue and converted into thermal energy. The local temperature quickly reaches a maximum of 85 ° C. It induces coagulative necrosis of focus tissue cells, but does not damage the tissues surrounding the treatment targ

Device: Echopulse (HIFU ablation)

Yao Zhong, Master

Jian Kuang, MD

This clinical trial is to evaluate the effectiveness and the safety of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules.

This clinical trial is a prospective, multicentre, randomized, controlled study of high intensity focused ultrasound (HIFU) treatment of benign thyroid nodules. this study will include 240 patients with benign thyroid nodules that meet all ths the inclusion / exclusion criteria and will be randomly divided into two groups at 1: 1 ratio. Patients in the test group will be treated with high intensity focused ultrasound (HIFU), while patients in the control group will be actively observed and followed up by ultrasound examination. The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms assessed by VAS score.

Patients in the test group will be treated with high intensity focused ultrasound (HIFU), while patients in the control group will be actively observed and followed up by ultrasound examination. during the follow-up period, the follow-up visits time and follow-up examination items (clinical examination, ultrasonic examination and laboratory examination etc.) were the same in the both groups

HIFU Treatment of Benign Thyroid Nodules

A Multi-center, Randomized, Controlled Trial of High Intensity Focused Ultrasound (HIFU) Treatment of Benign Thyroid Nodules

percentage of patients who achieve treatment success (volume reduction ratio \> 50%) at 12 months after HIFU treatment assessed by ultrasound examination

Using Visual Analogic Scale between (0-100 mm) to evaluate the improvement of appearance symptoms, compression symptoms and swallowing symptoms and pain.

With 0 being no pain and 100 being the worst pain imaginable

Incidence of local and/or general adverse reactions and other related symptoms at 1, 7 days and 1, 3, 6 and 12 months follow-up after treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Function Integrity of Neck Anatomy in Thyroid Surgery	NCT04666103	Thyroid Carcino... Thyroid Nodule ... Ablation; Retin...	Intraoperative ...	18 Years - 75 Years	Wuhan University
Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT	NCT04410601	Dysphagia, Esop... Dysphagia, Oral... Dysphagia Comes... Thyroiditis Thyroid Cancer Thyroid Neoplas... Thyroid Goiter Thyroid Nodule ...	Total thyroidec...	17 Years -	Umraniye Education and Research Hospital
CellFX ® Percutaneous Electrode (PE) Treatment of Benign Thyroid Nodules	NCT06117085	Thyroid Nodule ...	CellFX® Percuta...	18 Years - 80 Years	Pulse Biosciences, Inc.
Function Integrity of Neck Anatomy in Thyroid Surgery	NCT04666103	Thyroid Carcino... Thyroid Nodule ... Ablation; Retin...	Intraoperative ...	18 Years - 75 Years	Wuhan University
HIFU Treatment of Benign Thyroid Nodules	NCT04233398	Thyroid Nodule ...	Device: Echopul...	18 Years - 70 Years	Theraclion
HIFU Treatment of Benign Thyroid Nodules	NCT04233398	Thyroid Nodule ...	Device: Echopul...	18 Years - 70 Years	Theraclion
Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT	NCT04410601	Dysphagia, Esop... Dysphagia, Oral... Dysphagia Comes... Thyroiditis Thyroid Cancer Thyroid Neoplas... Thyroid Goiter Thyroid Nodule ...	Total thyroidec...	17 Years -	Umraniye Education and Research Hospital

Spots Global Cancer Trial Database for thyroid nodule (benign)