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

NCT04339478 | Completed

• 1 other identifier: FLUOBCC
• Study Type: observational
• Target: 180
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Thyroid Cancer; Thyroidectomy With Central Lymph Node Dissection

Keywords

Thyroidectomy; Central Lymph node compartment dissection; autofluorescence; FLUOBEAM XS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Detecting the changes of practice in performing total thyroidectomywith central lymph node dissection when monitoring parathyroids with autofluorescence.

  6 months

• Correlating autofluorescence with 24 hours post-operative PTH.

  6 months

• Correlating autofluorescence with postoperative hypocalcemia

  7months

• Identifying and analyzing problematic groups of patients

  7 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient is over 18 years old
• Patient scheduled for a non-emergency operation
• Patient eligible for total thyroidectomy

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Umraniye Education and Research Hospital: collaborator
• The Hashemite University: collaborator

Study Sites (2)

1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki

Thessaloniki, 54621, Greece

Location

Department of Surgery, Faculty of Medicine, Hashemite University

Zarqa, 13133, Jordan

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Theodossis Papavramidis, MD, PhD

  AHEPA University Hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: April 6, 2020
• Primary Completion: March 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1); GR (1)