| CTRI Number |
CTRI/2021/10/037410 [Registered on: 20/10/2021] Trial Registered Prospectively |
| Last Modified On: |
20/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Steroid In Esophageal Sticture |
|
Scientific Title of Study
|
Efficacy of Intralesional Steroid Injection on Esophageal Stricture Dilatation in Children:A Randomized Controlled Trial |
| Trial Acronym |
SIESD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 57 |
Protocol Number |
| 57/1800/11.2.21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuradha Rai |
| Designation |
Assistant Professor |
| Affiliation |
Chacha nehru bal chikitsalaya |
| Address |
Pediatric Medicine Department, Subdivision: Pediatric Gastroenterology, Room No: 303, Third Floor
Chacha Nehru Bal Chikitsalaya
Geeta Colony
Delhi
Geeta Colony
Delhi
East
DELHI
110031
India |
| Phone |
8800674851 |
| Fax |
|
| Email |
anuradharai2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Rai |
| Designation |
Assistant Professor |
| Affiliation |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department: Pediatric Medicine
Sub Division: Pediatric Gastroenterology
Room Number: 303
Chacha Nehru Bal Chikitsalaya
Geeta Colony
Delhi
Geeta Colony
East Delhi
Dehi
East
DELHI
110031
India |
| Phone |
91-8800674851 |
| Fax |
|
| Email |
anuradharai2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuradha Rai |
| Designation |
Assistant Professor |
| Affiliation |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department:Pediatric Medicine Room No 417, fourth Floor
Chacha Nehru Bal Chikitsalaya
Geeta Colony
Delhi
Geeta Colony
East Delhi
Delhi
East
DELHI
110031
India |
| Phone |
8800674851 |
| Fax |
|
| Email |
anuradharai2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department: Pediatric Medicine
Chacha Nehru Bal Chikitsalaya
Geeta Colony
East Delhi
Delhi |
|
|
Primary Sponsor
|
| Name |
Chacha Nehru Bal Chikitsalaya |
| Address |
Geeta Colony Delhi |
| 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 |
| Anuradha Rai |
Pediatric Gastroenterology Division of Chacha Nehru Bal Chikitsalaya (Room No 417- Endoscopy Room)) |
Endoscopy Room (417), Pediatric Gastroenterology Division Chacha Nehru Bal chikitsalaya ChikitsalayaGeeta Colony
East Delhi
East
DELHI |
8800674851
anuradharai2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K228||Other specified diseases of esophagus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intralesional steroid injection ( Triamcinolone) |
Intralesional steroid injection 10 mg/0.5 ml in 4 quadrants will be given in stricture segment with esophageal stricture dilatation in patients of esophageal stricture . Frequency of injection will be at 4 to 6 week interval and total for four times. It will be given intralesional in esophagus via 23 Gauze injector through Pediatric Esophagogsatroduodenoscope.
Dose:10 mg in four quadrant
Frequency:At four week Interval
Duration:Total four times |
| Comparator Agent |
Only esophageal dilatation of stricture will be done |
In this group no injection will be given. Only Dilatation of Esophageal Stricture will be done. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children having esophageal stricture and requiring more than three dilatation. |
|
| ExclusionCriteria |
| Details |
Long and Multiple Strictures
Post Sclerotherapy Strictures |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare number of dilatations in patients of benign refractory or recurrent esophageal stricture receiving intralesional steroid injection with dilatation or dilatation alone which will be measured as periodic dilatation index. |
After four sessions dilatation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To compare the level of dysphagia and the child’s eating behaviour between the two groups.
- To compare the effect of intralesional steroid injections on the luminal diameter and the stricture length between the two groups.
- To evaluate a possible influence of comedication (eg Proton pump inhibitor) on stricture recurrence.
- To compare complication rate (perforation and requirement of surgery) in two groups.
|
six month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/10/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized controlled trial of role of intralesional steroid in esophageal stricture dilatation. Its single blinded trial. It will include children with esophageal stricture requiring more than three dilatation to maintain their luminal patency with the age group between 6 months to 12 years. |