Does Indocyanine Imaging Scoring Predicts Postoperative PTH Levels at 24 Hours After Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intra-operative ICG fluarangiography predicts post-operative PTH values
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is over 18 years old
- •Patient scheduled for a non-emergency operation
- •Patient eligible for total thyroidectomy
排除标准
- •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)
研究组 & 干预措施
Study group
The group will include all adult patients that will sign ICF and will be operated for total thyroidectomy regardless of the undelying disease
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Intra-operative ICG fluarangiography predicts post-operative PTH values
时间窗: 24 hours
Whether ICG score of parathyroid glands after total thyroidectomy correlates with 24 post-operative values of PTH
次要结局
- ICG improves the intraoperative recognizability of the parathyroids(Intraoperative)
研究者
Papavramidis Theodossis
Associate Professor in Surgery
Aristotle University Of Thessaloniki