Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy With Central Lymph Node Compartment Dissection (FLUOBCC)

The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy with central lymph node compartment dissection.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer; Thyroidectomy With Central Lymph Node Dissection

Detailed Description

Real-time intraoperative identification and functional maintenance of structures are of major importance in endocrine surgery, with a critical role in clinical outcomes and patients' quality of life. Despite the advances in preoperative imaging techniques, there is still need for precise intraoperative visualizing [1]. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons [1-3]. Nowadays, attention is attracted to intraoperative imaging techniques using Near Infrared Fluorescence (NIRF) with endogenous or exogenous contrast agents. These imaging techniques are attractive in biomedicine due to its high penetration depth and low scattering in human tissue [2].

Autofluorescence is the ability of several natural substances or drugs to be fluorescent after the absorbance of light or radiation. It has been already proved that parathyroid glands emit their own light after near-infrared (NIR) around 820nm , providing high contrast to the surrounding tissues. This made near-infrared autofluorescence a potential useful tool in hands of experienced endocrine surgeons in order to distinguish parathyroid glands from other anatomic structures during thyroidectomies.

Approximately 7.6% of thyroid surgeries resulted in hypoparathyroidism, with 75% of these cases being transient and 25% being chronic. The mechanisms that underlie hypoPTH are related to disruption of parathyroid arterial supply or venous drainage, mechanical injury, thermal or electrical injury, and either intentional or inadvertent partial or complete removal.

The aim of the present study is to evaluate the value of intra-operative autofluorescence imaging concerning the unintentional excision rate of parathyroids during total thyroidectomy with central lymph node compartment dissection. Moreover, we are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Theodossis Papavramidis, MD, PhD; Phone Number: +306944536972; Email: papavramidis@hotmail.com

Study Locations

• Greece
  • Thessaloniki, Greece, 54621
    • Recruiting
    • 1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki
    • Contact: Theodosios Papavramidis, Ass.Prof.; Phone Number: +306944536972; Email: papavramidis@hotmail.com
    • Contact: Theodosios S Papavramidis, PhD; Phone Number: +306944536972; Email: papavramidis@hotmail.com
    • Principal Investigator: Ioannis Pliakos, Acad. Fellow
    • Principal Investigator: Antonios Michalopoulos, Professor
    • Sub-Investigator: Angeliki Chorti, Resident
    • Principal Investigator: Stavros Panidis, Acad. Fellow
    • Sub-Investigator: Georgios Kotsovolis, Anesthesiologist
    • Sub-Investigator: George Tzikos, Resident
• Jordan
  • Zarqa, Jordan, 13133
    • Recruiting
    • Department of Surgery, Faculty of Medicine, Hashemite University
    • Contact: Sohail Bakkar, PhD; Email: sohail.bakkar@gmail.com
• Turkey
  • Istanbul, Turkey, 34764
    • Not yet recruiting
    • Umraniye Education and Research Hospital
    • Contact: Ethem Unal, PhD; Email: drethemunal@gmail.com
    • Principal Investigator: Ethem Unal, PhD
    • Sub-Investigator: Kadir Yildirak, MD
    • Sub-Investigator: Kirkan Furkan, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Our sample size of 180 patients has been calculated after power analysis regarding other similar studies with an a=0.05 and Power=0.95.

Description

Inclusion Criteria:

1. Patient is over 18 years old
2. Patient scheduled for a non-emergency operation
3. Patient eligible for total thyroidectomy

Exclusion Criteria:

1. Patient is participating in another clinical trial which may affect this study's outcomes
2. Prior operation in the neck
3. Primary or secondary hyperparathyroidism
4. Vitamin D deficiency
5. Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Autofluorescence; The surgeon will perform the preplanned thyroidectomy with central lymph node compartment dissection with FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: Surgery date Duration of surgery Operation performed Procedure related comments Number and location of the visualized glands Intra-operative autofluorescence score (either 0 (no visualization or 1 visualization) for each gland
Control; The surgeon will perform the preplanned thyroidectomy with central lymph node compartment dissection without autofluorescence device. The following intraoperative variables will be recorded for all patients: Surgery date Duration of surgery Operation performed Procedure related comments Number and location of the visualized glands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy with central lymph node dissection	The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy with central lymph node dissection (TTCC). We will measure the number of parathyroids accidentally excised during TTCC with and without autofluorescence.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detecting the changes of practice in performing total thyroidectomywith central lymph node dissection when monitoring parathyroids with autofluorescence.	If autofluorescence is proved to be a useful tool in endocrine surgeons hands, the preservation of parathyroid glands during thyroidectomy with central lymph node dissection would be easier.	6 months
Correlating autofluorescence with 24 hours post-operative PTH.	To identify any correlation between intra-operative parathyroid glands autofluorescence with postoperative hypoparathyroidism. We are going to evaluate the number of parathyroids evaluated and we are going to correlate it with PTH.	6 months
Correlating autofluorescence with postoperative hypocalcemia	To identify any correlation between intra-operative parathyroid glands autofluorescence with postoperative hypoparathyroidism. We are going to evaluate the number of parathyroids evaluated and we are going to correlate it with Ca.	7months
Identifying and analyzing problematic groups of patients	This study will sign out the disadvantages of FLUOBEAM XS or cases that its use should be avoided.	7 months

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: Umraniye Education and Research Hospital; The Hashemite University
• Investigators: Principal Investigator: Theodossis Papavramidis, MD, PhD, AHEPA University Hospital of Thessaloniki, Greece

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Thyroidectomy; autofluorescence; FLUOBEAM XS; Central Lymph node compartment dissection
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms
• Other Study ID Numbers: FLUOBCC

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