| CTRI Number |
CTRI/2025/04/083818 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Indocyanine Green to predict low Calcium levels in patients going Total Thyroidectomy |
|
Scientific Title of Study
|
Role of Intraoperative Indocyanine Green Angiography to Predict Post Operative Hypocalcemia in Patients undergoing Total Thyroidectomy A Diagnostic Cohort Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suhani |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Surgical Disciplines
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drsuhani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhani |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Surgical Disciplines
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drsuhani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Makwana Jaymeen Rahulbhai |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Surgical Disciplines
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
South
DELHI
110029
India |
| Phone |
9825648000 |
| Fax |
|
| Email |
jaymeen96@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS
Dept of Surgical Disciplines
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suhani |
All India Institute of Medical Sciences |
Dept of Surgical Disciplines
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
South
DELHI |
9810534358
drsuhani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (2) ICD-10 Condition: E040||Nontoxic diffuse goiter, (3) ICD-10 Condition: E042||Nontoxic multinodular goiter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Total Thyroidectomy |
Conventional Total Thyroidectomy and its rate of parathyroid preservation. Duration of thyroidectomy is around 2 hours. |
| Intervention |
Indocyanine guided Total thyroidecotmy |
Total Thyroidectomy using Indocyanine green intra operatively to preserve parathyroid. Duration of thyroidectomy is around 2 hours. Half life of ICG is 3-4 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
Patients in whom 4 parathyroids were identified either intraoperatively or sum of in-situ glands and/ or auto transplanted and/ or parathyroids identified in histopathology was 4.
|
|
| ExclusionCriteria |
| Details |
1. Previous thyroid-parathyroid surgery
2. Pre-operative calcium treatment
3. Failure to obtain consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the diagnostic accuracy of intraoperative ICG angiography based functional scoring of parathyroids in predicting the occurrence of early postoperative hypocalcemia |
post operative day 0, post operative day 1, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess levels of io-PTH as compared to pre operative PTH |
post operative day 0 |
| Assess diagnostic accuracy of visual scoring in identifying parathyroid by measuring post operative hypocalcemia |
post operative day 0 |
| Assess diagnostic accuracy of indocyanine green in identifying parathyroid by measuring post operative hypocalcemia |
post operative day 0 |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study investigates the use of intra operative indocyanine green in predicting hypocalcaemia post total thyroidectomy. Total thyroidectomy carries a risk of hypocalcaemia affecting patient well being and requiring prolonged care. The study aims to evaluate ICG angiography’s ability to assess parathyroid vascularity, predicting early and permanent hypocalcaemia. The research will involve patients undergoing total thyroidectomy, utilising ICG angiography to score parathyroid viability. By comparing ICG angiography with traditional visual assessment and ioPTH levels the study seeks to establish a more reliable method for predicting post-operative hypocalcaemia. |