Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy?

NCT04204317 | Completed

• 1 other identifier: FLUOB
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy

Conditions

Thyroidectomy

Keywords

autofluorescence; parathyroid glands; thyroidectomy; FLUOBEAM XS

Outcome Measures

Primary Outcomes (1)

• The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy.

  The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy

  6 months

Secondary Outcomes (5)

• Detecting the changes of practice in performing total thyroidectomy when monitoring parathyroids with autofluorescence.

  6 months

• Comparing autofluorescence monitored minimal invasive total thyroidectomy with classic minimal invasive total thyroidectomy

  6 months

• Correlating autofluorescence with 24 hours post-operative PTH.

  7 months

• Identifying the cut-off points that predict low PTH levels (less than 20pg/ml)

  7 months

• Identifying and analyzing problematic groups of patients

  6 months

Study Arms (2)

Autofluorescence

The surgeon will perform the preplanned operation with FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments 5. Number and location of the visualized glands 6. Intra-operative autofluorescence score (either 0 (no visualization or 1 visualization) for each gland

Control

The surgeon will perform the preplanned operation without FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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

Study Sites (1)

AHEPA University Hospital of Thessaloniki

Thessaloniki, 54636, Greece

Location

Study Officials

• Theodossis S 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: December 3, 2019
• First Posted: December 18, 2019
• Study Start: December 17, 2019
• Primary Completion: March 27, 2020
• Study Completion: March 27, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-04

Locations

GR (1)