Neoplasms

Digestive System Diseases

All Conditions

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Rare Diseases

Esophageal Neoplasms

Deglutition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Esophageal Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Neuroprotective Agents

Herbal and Botanical

Flavonoid

Epigallocatechin gallate

Antioxidants

Protective Agents

Epigallocatechin

Studies investigating EGCG (purity 95% by high-performance liquid chromatography, obtained from Zhejiang Ningbo HEP Biotech Co., Ltd.) utilized a concentration of 4400 umol/L dissolved in 0.9% saline solution, which is administered three times a day for 1 week. Freshly prepared each time, the EGCG was administered 10 minutes before meals. The repeated slow swallowing of 30 ml of the EGCG solution was essential to ensure sustained contact of the drug on the esophageal walls

Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L

Epigallocatechin-3-gallate

Hanxi Zhao, MD

The investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.

A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer

Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial

Choking when swallowing was assessed by Stooler's dysphagia score (0-4, with 0 being none and 4 being completely unable to feed orally)

Pain when swallowing was assessed by numerical rating scale (0-5, with 0 being none and 5 being worst pain imaginable)

Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT

The prealbumin values were tested by biochemical analysis

The albumin values were tested by biochemical analysis

participants will be followed for the duration of EGCG treatment

Shandong Cancer Hospital and Institute

Deputy Chief Physician

Behaviors and Mental Disorders

Quality of Life

Patients with oesophageal cancer and dysphagia

Validation of different dysphagia scores

This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the oesophagus and gastro-oesophageal junction and to the Swedish language.

In the present study, our aim was to firstly, validate 3 commonly used scales for use in patients with dysphagia due to malignancy, and secondly, to validate them in the Swedish language. The 3 scales were: The Watson dysphagia scale, which was developed in studies on surgical treatment of reflux disease. It consists of questions about food with 9 different viscosity and solidity and the patient answer if they have problems with a specific food: never, sometimes or always when ingesting this. The scores are added and provides a range of 0-45 where 45 is the worst possible dysphagia. The Ogilvie score is a 5-graded scale 0-4 where 4 is total inability to swallow. The Goldschmid score is graded from 0-5 where 0 is inability to swallow and 5 is normal function. QoL was measured with validated instruments originating from the European Organization for Research and Treatment of Cancer (EORTC), which has a generic instrument that measures global QoL in patients with cancer (QLQ-C30) and a more symptom-specific instrument that is developed for cancer in the oesophagus and stomach (QLQ-OG25). These are well known, validated instruments that also have normal reference values for the healthy population. The symptom specific instrument QLQ-OG25 includes a dysphagia module consisting of 3 questions which is validated to malignant disease and food intake with the help of expert groups and deep interviews with patients.

Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer

Sahlgrenska University Hospital, Sweden

The Göteborg Medical Society, Sweden

Vastra Gotaland Region

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Nodule

Thyroiditis

Goiter

Endocrine System Diseases

Endocrine Gland Neoplasms

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?

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer	NCT06398405	Esophageal Canc... Dysphagia, Esop... Epigallocatechi...	Epigallocatechi...	18 Years -	Shandong Cancer Hospital and Institute
Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer	NCT03066167	Dysphagia, Esop... Esophageal Canc...	Validation of d...	-	Vastra Gotaland Region
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
Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer	NCT03066167	Dysphagia, Esop... Esophageal Canc...	Validation of d...	-	Vastra Gotaland Region
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 dysphagia, esophageal