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Comparing the effects of bougie, Balloon dilatation and incisional therapy on dysphagia in patients with benign esophageal stricture secondary to caustic injury

Protocol summary

Study aim
Comparing the treatments of bougie, Balloon dilatation and incisional therapy in patients with benign esophageal stricture secondary to caustic injury
Design
A clinical trial, with three intervention groups, with parallel groups, unblinded, randomized, phase 2 on 75 patients, randomized with Sealed envelope software.
Settings and conduct
This intervention will be implemented in the endoscopy department of Taleghani Hospital in Tehran. The participants will be randomly placed in three groups for interventions to remove esophageal stricture. Interventions will include bogie, balloon dilatation and shear therapy. All patients will be evaluated before the intervention, one month, three months and six months after the intervention in terms of clinical success, technical success, improvement of quality of life and occurrence of complications.
Participants/Inclusion and exclusion criteria
Inclusion criteria: inability to swallow, difficulty in swallowing, stenosis due to burn injury. Exclusion criteria: achalasia, esophageal cancer, INR>1.5, PLT<50,000, hemodynamic instability, eosinophilic esophagitis, esophageal surgery in the past month, need for surgery
Intervention groups
Intervention groups: Patients initially undergo endoscopy and barium swallow. Then each group is subjected to one of the bougie, balloon or incisional therapy
Main outcome variables
Dysphagia improvement, technical improvement, quality of life, body mass index, complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230425057990N2
Registration date: 2023-11-14, 1402/08/23
Registration timing: prospective

Last update: 2023-11-14, 1402/08/23
Update count: 0
Registration date
2023-11-14, 1402/08/23
Registrant information
Name
Saeed Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2459 6000
Email address
saeedabdi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of bougie, Balloon dilatation and incisional therapy on dysphagia in patients with benign esophageal stricture secondary to caustic injury
Public title
The effect of endoscopic treatments in the treatment of benign esophageal stricture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unable to swallow Difficulty to swallow Benign esophageal stricture secondary to caustic injury
Exclusion criteria:
achalasia Untreated reflex Esophageal surgery during the last month Patients needing surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two groups using the random block method. The number of blocks will be 6 and in each block 4 patients will be included in the study order. Random allocation of blocks of patients to three treatment groups will be done through Sealed Envelope online software. The randomized list of blocks will be placed in sealed envelopes and will be provided to prescribers on a daily basis.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee in research of research institute for gastroenterology and liver disease
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.SBMU.RIGLD.REC.1402.005

Health conditions studied

1

Description of health condition studied
benign esophageal stricture
ICD-10 code
K22.2
ICD-10 code description
Esophageal obstruction

Primary outcomes

1

Description
Technical success
Timepoint
Before the intervention, one month, three months and six months after the intervention
Method of measurement
Based of lumen diameter with residual stenosis less than 30%

2

Description
Technical success
Timepoint
Before the intervention, one month, three months and six months after the intervention
Method of measurement
Improvement of dysphagia symptoms

Secondary outcomes

1

Description
Generic Quality of life
Timepoint
Before the intervention, one month, three months and six months after the intervention
Method of measurement
EuroQol-5D (EQ-5D) index

2

Description
Physically quality of life
Timepoint
Before the intervention, one month, three months and six months after the intervention
Method of measurement
body mass index

3

Description
complication
Timepoint
up to 6 hours after the intervention
Method of measurement
Physical examination and history

Intervention groups

1

Description
Intervention group: bougie-For this group of patients, we start with 7 to 9 mm bougie. Then, according to the response to the treatment, we increase the size of the bogie up to 13-15 mm in three stages (1-3 months apart) to control the patient's symptoms (dysphagia).
Category
Treatment - Devices

2

Description
Intervention group: Balloon dilatation-For patients in this group, we start with a 7 to 9 mm balloon and increase it to 15 mm to control the patient's symptoms (dysphagia). At each stage (within a time interval of one to three months), we will have up to three numbers of size increase.
Category
Treatment - Devices

3

Description
Intervention group: incisional therapy-For patients in this group, cutting with a special knife is used to improve the esophageal stricture.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Endoscopy ward, Taleghani Hospital
Full name of responsible person
Amir Sadeghi
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 2303 1505
Email
Amirsadeghimd@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
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
Ramyar Zaman Golzari
Position
Gastroenterologist assistant
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
ramyar.golzari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Abdi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
saeedabdi75@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Forootan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
mojganforootan@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only the information related to the study protocol, statistical analysis plan and clinical study report will be made available to the requestors (and not publicly) to other researchers for guidance for further studies.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Researchers, students and professors in the field of gastroenterology
Under which criteria data/document could be used
For use in further research and if the source is cited
From where data/document is obtainable
corresponding author Dr. Saeed Abdi saeedabdi75@yahoo.com
What processes are involved for a request to access data/document
Send a request via email to the responsible author and mention the reason for the request and how to use the tens
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