Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair

Tracheo Esophageal Fistula Clinical Trial

Official title:

Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01287312
• Other study ID #: shlomoco-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2011
• Last updated: January 31, 2011
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2011
• Source: Hadassah Medical Organization
• Contact: shlomo cohen, MD
• Phone: +972 2 6776817
• Email: shlomoco[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: ISRAEL: Ministry of Health - Director General
• Study type: Interventional

Clinical Trial Summary

Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.

The investigators want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Description:

Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.

We want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 20 Years

Eligibility

Inclusion Criteria:

• children age 1 month- 20 years old with recurrent TEF.

• Failure of surgical repair.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Fistula
• Fistula
• Tracheo Esophageal Fistula
• Tracheoesophageal Fistula

Intervention

Procedure:
• Endoscopic repair of recurrent TEF by trichloroacetic acid aplications

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of the fistula	Closure of the fistula
Secondary	clinical and pulmonary improvment