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Comparing the effectiveness of balloon along with botox injection compared to balloon alone in achalasia patients

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240629062273N1
Enrollment
70
Registered
2024-07-23
Start date
2024-06-29
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

achalasia. Achalasia of cardia

Interventions

Intervention 1: 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 Childre

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 14 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmohammad aghaee

Shahid Beheshti University of Medical Sciences

aghaee.moham@gmail.com22257997

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026