Trial Title:
Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy With Central Lymph Node Compartment Dissection
NCT ID:
NCT04339478
Condition:
Thyroid Cancer
Thyroidectomy With Central Lymph Node Dissection
Conditions: Official terms:
Thyroid Neoplasms
Conditions: Keywords:
Thyroidectomy
Central Lymph node compartment dissection
autofluorescence
FLUOBEAM XS
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Summary:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki
Address:
City:
Thessaloniki
Zip:
54621
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Theodosios Papavramidis, Ass.Prof.
Phone:
+306944536972
Email:
papavramidis@hotmail.com
Contact backup:
Last name:
Theodosios S Papavramidis, PhD
Phone:
+306944536972
Email:
papavramidis@hotmail.com
Investigator:
Last name:
Ioannis Pliakos, Acad. Fellow
Email:
Principal Investigator
Investigator:
Last name:
Antonios Michalopoulos, Professor
Email:
Principal Investigator
Investigator:
Last name:
Angeliki Chorti, Resident
Email:
Sub-Investigator
Investigator:
Last name:
Stavros Panidis, Acad. Fellow
Email:
Principal Investigator
Investigator:
Last name:
Georgios Kotsovolis, Anesthesiologist
Email:
Sub-Investigator
Investigator:
Last name:
George Tzikos, Resident
Email:
Sub-Investigator
Facility:
Name:
Department of Surgery, Faculty of Medicine, Hashemite University
Address:
City:
Zarqa
Zip:
13133
Country:
Jordan
Status:
Recruiting
Contact:
Last name:
Sohail Bakkar, PhD
Email:
sohail.bakkar@gmail.com
Facility:
Name:
Umraniye Education and Research Hospital
Address:
City:
Istanbul
Zip:
34764
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Ethem Unal, PhD
Email:
drethemunal@gmail.com
Investigator:
Last name:
Ethem Unal, PhD
Email:
Principal Investigator
Investigator:
Last name:
Sema Yuksekdag, MD
Email:
Principal Investigator
Investigator:
Last name:
Kadir Yildirak, MD
Email:
Sub-Investigator
Investigator:
Last name:
Kirkan Furkan, MD
Email:
Sub-Investigator
Start date:
April 6, 2020
Completion date:
August 30, 2022
Lead sponsor:
Agency:
Aristotle University Of Thessaloniki
Agency class:
Other
Collaborator:
Agency:
Umraniye Education and Research Hospital
Agency class:
Other
Collaborator:
Agency:
The Hashemite University
Agency class:
Other
Source:
Aristotle University Of Thessaloniki
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04339478
