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A prospective study to compare the efficacy of ICG dye Angiography and Parathyroid Hormone measurement in early prediction of risk of decrease in blood calcium levels after thyroid surgery.

Comparison of Indocyanine Green Angiography vs Intraoperative Parathyroid Hormone measurement in early prediction of risk of post thyroidectomy hypocalcemia : a prospective cohort study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042270
Enrollment
100
Registered
2022-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C73- Malignant neoplasm of thyroid gland Health Condition 2: E040- Nontoxic diffuse goiter Health Condition 3: E049- Nontoxic goiter, unspecified Health Condition 4: E049- Nontoxic goiter, unspecified Health Condition 5: E042- Nontoxic multinodular goiter Health Condition 6: E041- Nontoxic single thyroid nodule Health Condition 7: E048- Other specified nontoxic goiter

Interventions

Intervention1: Diagnostic dye indocyanine green: Drug: Indocyanine Green 25 mg of lypophilized sterile powder ICG is mixed with 5 mL of sterile water, for injection and shaken well for at least 3 minu
1-gray/heterogeneous (partially vascularized)
2-white (well vascularized). Serum iPTH levels will be measured 20 min after total thyroidectomy. Serum ionized calcium will be done 6 hours post surgery and on the morning and evening of postoperativ

Sponsors

Department of Endocrine Surgery SGPGIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection for both benign and malignant conditions. 2. Normal renal and hepatic functions. 3. Absence of a history of hypersensitivity reactions to iodine or indocyanine green. 4. Able to understand the nature and protocol of the study and its procedures. 5.Willingness to participate with the subsequent signing of informed consent

Exclusion criteria

Exclusion criteria: 1. Age to iodine or to indocyanine green. 4. Pregnancy or lactation 5.Inability to understand the nature and procedures of the study. 6. Previous thyroid and parathyroid surgery. 7. Patients with known preoperative hyperparathyroidism or any concomitant parathyroid disease. 8. Previous treatment with calcium.

Design outcomes

Primary

MeasureTime frame
The primary end point will be the need for calcium supplementation. Patients will be administered calcium supplementation when labelled as clinically and biochemically hypocalcemic. Timepoint: Within 48 hours post surgery—

Secondary

MeasureTime frame
Calcium supplements will be given to only those who will develop clinical or severe biochemical hypocalcemia. Criteria for predicting hypocalcemia will be levels of iPTH less than 4.28 pmol/lTimepoint: 72-96 hours post surgery—

Countries

India

Contacts

Public ContactYuvraj Devgan

SGPGIMS, Lucknow

devgan55@gmail.com9896005273

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026