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Completed

NCT Number: NCT03910049

Does Indocyanine Imaging Scoring Predicts Postoperative Parathormone Levels at 24 Hours After Total Thyroidectomy

The aim of the present study is to evaluate the prognostic value of intra-operative indocyanine staining scoring concerning 24 hours post-operative PTH levels and the possible advantages that its' use can give in terms of clinical practice compared to conventionally operated patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unit of Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece, Thessaloniki, Please Enter the State Or Province, Greece

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About this study

Study objectives are:

  • Detecting the changes of practice in performing total thyroidectomy with ICG.
  • Comparing ICG-performed minimal invasive total thyroidectomy
  • Identifying the cut-off points that predict low PTH levels (less than 20pg/ml)
  • Identifying and analyzing problematic groups of patients The study is designed as a prospective observational multi-center study. Any patient that has indication for a total thyroidectomy will be considered eligible.

The study will be conducted until 60 subjects are included. It is estimated that it will take up to 3 months to enroll the patients.

Pre-Surgery: Procedures preformed such as routine hospital examinations, antibiotic prophylactic treatment, anticoagulant treatment and diet will be according to the standard management protocol and will be recorded for the study. The following pre-surgery information will be recorded:

  • Demographic information including: name, age, gender, ethnicity
  • Height, weight, BMI and American Society of Anesthesiologists physical status classification system (I-VI)
  • Behavioral history (Smoking, alcohol or drug use)
  • Preoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH, VitD)
  • Diagnosis including clinical observations and previous imaging results
  • Pre-operative characteristics of the adenoma
  • Medications
  • Current and past history of surgical and medical comorbidities

Intra-operative: The surgeon will perform the preplanned operation. 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 ICG score (ranging from 1 to 3 [5]) for each grand

Pathology data form: The following pathology data will be recorded for all patients:

  • Post-operative diagnosis including pathology report
  • Possible parathyroids excised Postoperative follow-up: Follow-up evaluation will be performed during hospitalization

1 Postoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Indocyanine green

Drug

Indocyanine green will be administered intravenously to patients enrolled in this study after the completion of total thyroidectomy in order to assess the visibility of parathyroid glands and to assess the possible correlation of ICG score with post-operative parathormone levels in order to predict post-thyroidectomy hypoparathyroidism.

Other names: indocyanine green solution

Primary outcomes

  1. Intra-operative ICG fluarangiography predicts post-operative PTH values

    Time frame: 24 hours

    Whether ICG score of parathyroid glands after total thyroidectomy correlates with 24 post-operative values of PTH

Secondary outcomes

  1. ICG improves the intraoperative recognizability of the parathyroids

    Time frame: Intraoperative

    To assess the ability of ICG flurangiography to increase recognizability of parathyroid glands during total thyroidectomy based on ICG score of the parathyroids.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Does Indocyanine Imaging Scoring Predicts Postoperative PTH Levels at 24 Hours After Total Thyroidectomy

Acronym: ICGPREDICT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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