The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

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 Overview

• Status: Recruiting
• Conditions: Thyroid Diseases; Surgery
• Intervention / Treatment: Procedure: TOETVA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jesse D Pasternak, MD; Phone Number: 14163405195; Email: jesse.pasternak@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2C4
      • Recruiting
      • Univeristy Health Network
      • Contact: Jesse D Pasternak, MD; Phone Number: 4163405195; Email: jesse.pasternak@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOETVA; Transoral Endoscopic Thyroidectomy Vestibular Approach	Procedure: TOETVA; Transoral Endoscopic Thyroidectomy Vestibular Approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative recurrent laryngeal nerve palsy	Number of participants with post-operative recurrent laryngeal nerve palsy	12 months
Postoperative hypocalcemia	Number of participants with postoperative hypocalcemia	12 months
Neck incision	Number of conversions to open	1 month
Rate of oral infections	Number of participants with oral infections	12 months
Rate of hematoma	Number of participants with hematomas	1 month
Rate of seroma	Number of participants with seromas	1 month
Rate of neck infection	Number of participants with neck infections	12 months
Rate of subcutaneous emphysema	Number of participants with subcutaneous emphysema	12 months
Rate of gas-induced embolism	Number of participants with gas-induced embolism	12 months
Surgical time	Surgical time in hours	until surgical discharge, average of 24 hours
Length of stay	Length of stay in days	until surgical discharge, average of 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Score	EORTC Thyroid specific Health related quality of life	12 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Jesse D Pasternak, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: April 11, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 11, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: TOETVA; Transoral Endoscopic Thyroidectomy Vestibular Approach
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: 19-5679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No