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Comparison of the efficacy of esophageal balloon dilatation and Botox injection, with esophageal balloon dilatation alone, in children with achalasia referred to Mofid children hospital

Protocol summary

Study aim
The study's aim is to assess the rate of improvement in gastrointestinal and non-gastrointestinal symptoms in achalasia patients receiving both balloon dilatation and botox injection concurrently, compared to balloon dilation alone, in order to understand patients' reasons for visits, gastrointestinal complications, endoscopy indications, and determine the most effective treatment approach.
Design
The present study is a clinical trial with a historical control group. The intervention group is selected from international patients with a diagnosis of esophageal achalasia in need of treatment For this group, balloon expansion is done with botox injection.
Settings and conduct
The present study is a clinical trial. The intervention group will be selected from patients diagnosed with esophageal achalasia in need of treatment, who are referred to the endoscopy depatement. For this group, balloon dilatation was performed simultaneously with botox injection.
Participants/Inclusion and exclusion criteria
Patients diagnosed with esophageal achalasia and aged 3 months to 14 years presenting with symptoms of dysphagia, weight loss, respiratory symptoms, and chest pain due to food aspiration, and exhibiting signs of FTT, abdominal pain, chest pain, or dental caries. Patients who underwent balloon dilation for reasons other than achalasia, such as anastomotic stricture following esophageal atresia, syndromic FTTs, abdominal pain from alternative etiologies, and chest pain attributable to cardiac conditions
Intervention groups
patients diagnosed with esophageal achalasia in need of treatment, who were referred to the endoscopy department of Mofid Children's Hospital. For this group, balloon dilatation was performed simultaneously with botox injection.
Main outcome variables
changes in clinical symptoms and sign

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240629062273N1
Registration date: 2024-07-23, 1403/05/02
Registration timing: registered_while_recruiting

Last update: 2024-07-23, 1403/05/02
Update count: 0
Registration date
2024-07-23, 1403/05/02
Registrant information
Name
mohammad aghaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2629 4599
Email address
aghaee.moham@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-29, 1403/04/09
Expected recruitment end date
2025-06-30, 1404/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of esophageal balloon dilatation and Botox injection, with esophageal balloon dilatation alone, in children with achalasia referred to Mofid children hospital
Public title
Comparing the effectiveness of balloon along with botox injection compared to balloon alone in achalasia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with esophageal achalasia and aged three months to 14 years presenting with symptoms of dysphagia, weight loss, respiratory symptoms, and chest pain due to food aspiration, and exhibiting signs of failure to thrive (FTT), abdominal pain, chest pain, or dental caries.
Exclusion criteria:
Patients who underwent balloon dilation for reasons other than achalasia, such as anastomotic stricture following esophageal atresia, syndromic FTTs, abdominal pain from alternative etiologies, and chest pain attributable to cardiac conditions
Age
From 3 months old to 14 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
shariati street mofid hospital
City
tehran
Province
Tehran
Postal code
1986613816
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.SBMU.MSP.REC.1400.636

Health conditions studied

1

Description of health condition studied
achalasia
ICD-10 code
K22.0
ICD-10 code description
Achalasia of cardia

Primary outcomes

1

Description
clinical symptoms and sign
Timepoint
0, 6 months, 12 months, 24 months , 36 months after the injection
Method of measurement
clinical symptoms and sign after the procedure

Secondary outcomes

1

Description
radiologic signs, growth parameters
Timepoint
0, 6, 12, 24 and 36 months after injection
Method of measurement
radiologic signs based on radiologic features and growth parameters based on growth indexes

Intervention groups

1

Description
Intervention group: The intervention group will be selected from patients with esophageal achalasia in need of treatment, who were referred to the endoscopy department of Mofid Children's Hospital. For this group, balloon dilatation was performed simultaneously with botox injection.
Category
Treatment - Drugs

2

Description
Control group: control group will be selected from patients with achalasia who underwent balloon dilatation alone in Mofid Hospital past years.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
mofid children hospital
Full name of responsible person
mohammad aghaee
Street address
shariati street
City
tehran
Province
Tehran
Postal code
1986613816
Phone
+98 912 006 2195
Email
aghaee.moham@gmail.com
Web page address
https://pgnrc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mohammad aghaee
Street address
shariati
City
tehran
Province
Tehran
Postal code
1986613816
Phone
+98 915 860 2700
Email
aghaee.moham@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mohammad aghaee
Position
specialist of pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
shariati
City
tehran
Province
Tehran
Postal code
1986613816
Phone
22257997
Email
aghaee.moham@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mohammad aghaee
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
shariati
City
tehran
Province
Tehran
Postal code
1986613816
Phone
22257997
Email
aghaee.moham@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mohammad
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
shariati
City
tehran
Province
Tehran
Postal code
1986613816
Phone
۰۹۱۲۹۰۰۶۲۱۹۵
Email
aghaee.moham@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparison of the efficacy of esophageal balloon dilatation and Botox injection, with esophageal balloon dilatation alone, in children with achalasia referred to Mofid children hospital
When the data will become available and for how long
1404
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, or people who work in the relevant industries can apply to receive them.
Under which criteria data/document could be used
Deidentified individual participant data (IPD) and supporting documents from this study will be shared for secondary analyzes focusing on the efficacy and safety of the combined treatment approach for achalasia.
From where data/document is obtainable
Researchers must submit a detailed proposal to the data access committee, which will review requests based on scientific merit, potential impact, and ethical considerations. Data will be shared through a secure platform, ensuring compliance with data protection regulations and maintaining participant confidentiality.
What processes are involved for a request to access data/document
To access research data or documents, researchers must submit a detailed proposal, which is reviewed by a data access committee for scientific merit and ethical considerations. If approved, researchers sign a Data Use Agreement outlining confidentiality and data protection measures. Data is then shared through a secure platform, with ongoing compliance monitored to ensure adherence to the agreed-upon policies.
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