Comparison of the efficacy of two kinds of treatment in idiopathic achalasia: Botolinum Toxin Injection and Sclerotherapy.

Comparison of Botolinum Toxin Injection and Sclerotherapy in treatment of idiopathic achalasia in case of pneumatic balloon dilation contraindication.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201108157335N1

Enrollment

Registered

2011-08-28

Start date

2009-11-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Idiopathic achalasia. Achalasia of cardia

Interventions

Intervention 1: Patients diagnosed with achalasia in this center ,will be carefully checked for PBD contraindications, then they will randomly divided in two groups one group will be treated by Botex,

Treatment - Drugs

Patients diagnosed with achalasia in this center ,will be carefully checked for PBD contraindications, then they will randomly divided in two groups one group will be treated by Botex, using Dysport 5

Patients diagnosed with achalasia in this center ,will be carefully checked for PBD contraindications, then they will randomly divided in two groups ,the second group will be treated by EO, using Etha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria:newly diagnosed Idiopathic achalasia patients with pneumatic balloon dilation contraindication :sigmoid esophagus; epipherenic diverticulum & refusing from pneumatic balloon dilation studied. Exclusion criteria:secondary achalasia & those who refusing from participating in study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Timed barrim esophagoram. Timepoint: before treatment & 1.5 &6&12 months after the last injection. Method of measurement: measuring the retained barrium height & volume in 5th minute after swallow.;Clinical symptom. Timepoint: before treatment & 1.5 &3&9 &6&12 months after the last injection. Method of measurement: filling standardize Achalasia questionary,investigating patients by their clinical symptoms.(solid & liquid dysphagia,active & passive regurgitation,chest pain).;Manometry. Timepoint: before treatment &1.5 month after the last injection. Method of measurement: measuring resting & swallowin LES pressure by catheters which are placed in LES zoon.	—

Measure

Time frame

Timed barrim esophagoram. Timepoint: before treatment & 1.5 &6&12 months after the last injection. Method of measurement: measuring the retained barrium height & volume in 5th minute after swallow.;Clinical symptom. Timepoint: before treatment & 1.5 &3&9 &6&12 months after the last injection. Method of measurement: filling standardize Achalasia questionary,investigating patients by their clinical symptoms.(solid & liquid dysphagia,active & passive regurgitation,chest pain).;Manometry. Timepoint: before treatment &1.5 month after the last injection. Method of measurement: measuring resting & swallowin LES pressure by catheters which are placed in LES zoon.

—

Secondary

Measure	Time frame
Ulcer. Timepoint: in each endoscopy which is done for the injection. Method of measurement: by observation.;Chest pain. Timepoint: whithin first 24 hours after each injection. Method of measurement: by asking patients.;Perforation. Timepoint: whithin first 24 hours after each injection. Method of measurement: by observation & examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Javad Mikaeli

Digestive Disease Research Center Shariati Hospital

mikaeli@ams.ac.ir+98 21 8241 5135

Outcome results

None listed

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