Clinical trial NCT04842942: The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
Official title: The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Thyroid Diseases
Surgery
Keywords: TOETVA
Transoral Endoscopic Thyroidectomy Vestibular Approach
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
Primary purpose: OTHER

Brief summary: This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure.

Detailed description: Type of Study This is a single center, prospective case series

Sample Size Since this is a feasibility study we will first include 15 patients. If we find the TOETVA a safe and feasible approach, we will perform the same study in more patients using the results of this study for a power size calculation.

Study Population Patients (\> 18 years) undergoing (para)thyroid surgery for the indication of a benign or indeterminate thyroid nodule, well differentiated papillary thyroid carcinoma, well-controlled Grave's disease or a parathyroid adenoma.

Study Design This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure.

Study Intervention The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.

Primary Objective The study objective is to assess the safety and feasibility of this procedure in a small cohort of patients at University Health Network Toronto, Ontario.

Endpoints of the study The main study endpoints consist of

1. Surgical Outcomes: rate of post-operative recurrent laryngeal nerve palsy, rate of post-operative hypocalcemia, and rate of neck incision (conversion to open), oral infections, neck infection, hematoma, seroma, subcutaneous emphysema, gas-induced embolism, surgical time, and length of stay.
2. Quality of Life - EORTC Thyroid specific Health related quality of life

These endpoints will be compared to historical age/indication controls for analysis.

Eligibility criteria: Inclusion Criteria:

- Patients needing surgery for: Benign or indeterminate nodule less than 6 cm in size or; T1 well differentiated papillary carcinoma less than 2 cm in size or; Well-controlled Grave's disease or; Parathyroid adenoma.

* Total thyroid size is 7-8 cm (no more than 10 cm)
* Their age is ≥18 years and ≤80 years
* Able to give written consent

Exclusion Criteria:

* - History of neck surgery or neck radiotherapy
* Recurrent thyroid disease
* Lymph node metastases
* Presence of intraoral infections
* Presence of extrathyroidal or substernal extensions
* Smoking
* Morbid obesity
* Contra-indication to general anesthesia with nasotracheal intubation
* Previous mediastinal surgery
* Any anatomical anomaly that in the opinion of the investigator may render the intervention more difficult (ex. variations in the structure of the platysmas muscle)
* Any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure

Primary outcomes:
measure: Post-operative recurrent laryngeal nerve palsy
timeFrame: 12 months
measure: Postoperative hypocalcemia
timeFrame: 12 months
measure: Neck incision
timeFrame: 1 month
measure: Rate of oral infections
timeFrame: 12 months
measure: Rate of hematoma
timeFrame: 1 month
measure: Rate of seroma
timeFrame: 1 month
measure: Rate of neck infection
timeFrame: 12 months
measure: Rate of subcutaneous emphysema
timeFrame: 12 months
measure: Rate of gas-induced embolism
timeFrame: 12 months
measure: Surgical time
timeFrame: until surgical discharge, average of 24 hours
measure: Length of stay
timeFrame: until surgical discharge, average of 24 hours
Secondary outcomes:
measure: Quality of Life Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Univeristy Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jesse D Pasternak, MD
role: PRINCIPAL_INVESTIGATOR
References: