| CTRI Number |
CTRI/2018/07/015095 [Registered on: 27/07/2018] Trial Registered Prospectively |
| Last Modified On: |
19/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the rates of decreased calcium levels in blood after total thyroid removal operation when using Indocyanine green dye v/s no dye usage |
|
Scientific Title of Study
|
Incidence of postoperative hypocalcemia after Indocyanine Green fluorescence guided v/s Conventional assessment of parathyroid function following total thyroidectomy - A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keshav Agarwal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines
All India Institute of Medical Sciences, New Delhi
Ansari Nagar, New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9818442016 |
| Fax |
|
| Email |
keshavagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vathulru Seenu |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines
All India Institute of Medical Sciences, New Delhi
Ansari Nagar, New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9910834455 |
| Fax |
|
| Email |
varnaseenu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keshav Agarwal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines
All India Institute of Medical Sciences, New Delhi
Ansari Nagar, New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9818442016 |
| Fax |
|
| Email |
keshavagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines
All India Institute of Medical Sciences, New Delhi
Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
All India Institute of Medical Sciences, New Delhi
Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Keshav Agarwal |
All India Institute of Medical Sciences, New Delhi |
Department of Surgical Disciplines
All India Institute of Medical Sciences, New Delhi
Ansari Nagar, New Delhi - 110029
New Delhi
DELHI |
9818442016
keshavagar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
All Patients undergoing total thyroidectomy for both benign and malignant conditions, (1) ICD-10 Condition: E012||Iodine-deficiency related (endemic) goiter, unspecified, (2) ICD-10 Condition: E010||Iodine-deficiency related diffuse(endemic) goiter, (3) ICD-10 Condition: E011||Iodine-deficiency related multinodular (endemic) goiter, (4) ICD-10 Condition: E011||Iodine-deficiency related multinodular (endemic) goiter, (5) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (6) ICD-10 Condition: E040||Nontoxic diffuse goiter, (7) ICD-10 Condition: E049||Nontoxic goiter, unspecified, (8) ICD-10 Condition: E042||Nontoxic multinodular goiter, (9) ICD-10 Condition: E048||Other specified nontoxic goiter, (10) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, (11) ICD-10 Condition: E050||Thyrotoxicosis with diffuse goiter, (12) ICD-10 Condition: E052||Thyrotoxicosis with toxic multinodular goiter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine Green dye injection |
After total thyroidectomy, Indocyanine Green dye will be mixed with 5 ml sterile water and 2.5 ml will be injected intravenously. The injection could be repeated until a maximum dose of 5 mg per kg per day . The catheter will be flushed after each injection for a rapid image gain. After approximately 1–2min, images will be acquired using the SPY Fluorescent Imaging system |
| Comparator Agent |
No injection of Indocyanine Green dye |
After total thyroidectomy, no dye will be injected. The parathyroid glands will only be visually assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All Patients undergoing total thyroidectomy for both benign and malignant conditions |
|
| ExclusionCriteria |
| Details |
1. Patients with known renal impairment or iodine allergy
2. Patients with concomitant hyperparathyroidism
3. Age< 18 years Age > 70 years
4. Pregnancy
5. Patients undergoing central
compartment neck dissection or modified radical neck dissection |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the use of ICG angiography to assess parathyroid gland function after thyroid surgery and thereby, take appropriate steps to prevent postoperative hypocalcemia
2. To compare the incidence of postoperative hypocalcemia after ICG guided assessment of parathyroid function with that of conventional methods |
Postoperative Day 0 and postoperative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the correlation between parathyroid fluorescence after ICG dye injection and POD0 and POD1 calcium levels and POD1 PTH levels |
Postoperative day 0 and postoperative day 1 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2018 |
| Date of Study Completion (India) |
19/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Identification of parathyroid glands is one of the main concerns in thyroid surgery. It is usually very difficult to distinguish parathyroid glands from thyroid and surrounding tissues in the neck due to their small size and variable location. The percentage of incidental parathyroidectomies is around 16% The incidence rate of hypocalcemia can reach up to 4.5% in total thyroidectomies rising to 11.5% in thyroidectomies with central node dissection. These rates can increase to 50% for transient hypocalcemia and 13.8% for permanent hypocalcemia in total thyroidectomies. The main cause of hypocalcaemia after total thyroidectomy is hypoparathyroidism due to intraoperative damage to the parathyroid glands by trauma, inadvertent parathyroid gland removal or devascularization. The extent of damage to the parathyroid glands is difficult to predict during surgery. The feasibility of ICG in assessing the parathyroid gland function in patients undergoing thyroidectomy and thereby preventing postoperative hypocalcemia is being compared with our conventional methods in this study |