The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

NCT ID: NCT04842942

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2022-07-31

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.

Conditions

Thyroid Diseases; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TOETVA

Transoral Endoscopic Thyroidectomy Vestibular Approach

Group Type: EXPERIMENTAL

TOETVA

Intervention Type: PROCEDURE

Transoral Endoscopic Thyroidectomy Vestibular Approach

Interventions

TOETVA

Transoral Endoscopic Thyroidectomy Vestibular Approach

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesse D Pasternak, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Univeristy Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jesse D Pasternak, MD

Role: CONTACT

jesse.pasternak@uhn.ca

14163405195

Facility Contacts

Jesse D Pasternak, MD

Role: primary

jesse.pasternak@uhn.ca

4163405195

Other Identifiers

19-5679

Identifier Type: -

Identifier Source: org_study_id