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Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01287312
First received: January 27, 2011
Last updated: January 31, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Tracheo Esophageal Fistula
 Procedure: Endoscopic repair of recurrent TEF by trichloroacetic acid aplications

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Closure of the fistula
    Closure of the fistula


Secondary Outcome Measures:
  • clinical and pulmonary improvment

Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Month to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children age 1 month- 20 years old with recurrent TEF.
  • Failure of surgical repair.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287312

Contacts
Contact: shlomo cohen, MD +972 2 6776817 shlomoco@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Hadas Lemberg, PhD     +972 2 6776095     lhadas@hadassah.org.il    
Principal Investigator: Shlomo Cohen, DM            
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Shlomo Cohen, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01287312     History of Changes
Other Study ID Numbers: shlomoco-HMO-CTIL
Study First Received: January 27, 2011
Last Updated: January 31, 2011
Health Authority: ISRAEL: Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
We will treat children age 1 month to 20 years with recurrent TEF after surgical failure

Additional relevant MeSH terms:
Tracheal Diseases
Esophageal Diseases
Esophageal Fistula
Fistula
Tracheoesophageal Fistula
Gastrointestinal Diseases
 Digestive System Diseases
Digestive System Fistula
Pathological Conditions, Anatomical
Respiratory Tract Fistula
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013