Investigation of the Effect of Systemic Steroids on Treatment and Prevention of Recurrent Tracheal Stenosis in Postoperative Patients

Tracheal Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855502
• Other study ID #: F93162
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2016
• Last updated: April 2, 2017
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: National Research Institute of Tuberculosis and Lung Disease, Iran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

tracheal stenosis is the result of abnormal wound-healing processes leading to hypertrophic scar formation and obstruction of the airway lumen by excess granulation tissue. This process is progressive so treatment and prevention is essential. Resection-anastomosis of the trachea is becoming the standard of care in many centers and gives the most consistent results in both adult and pediatric patients. But recurrence stenosis, re-granulation and re-inflammation are probable. This study aimed to assess the efficacy of systemic prednisolone on prevention of recurrent tracheal stenosis after surgery.

Description:

Tracheal stenosis affects 4-13% of adults and occurs in 1-8% of neonates after prolonged intubation in United States. The causes of adults' tracheal stenosis include trauma, chronic inflammatory diseases, benign neoplasm, malignant neoplasm and collagen vascular diseases. The most common cause of tracheal stenosis continues to be trauma, which can be internal (prolonged endotracheal intubation, tracheostomy, flame, burn injury) or external (neck trauma). Approximately 90% of chronic subglottic stenosis in children and adults results from endotracheal intubation or tracheostomy and about 10% results from other causes.

The resection anastomosis is the most effective treatment to cure this condition. The other treatments are mechanical dilation (dilators, rigid bronchoscopes), stents, laser co2, diode, and cold knife. But they are not as effective as resection anastomosis. Rigid bronchoscopes or dilators may shear the mucosa leading to further damage. Resection of all damaged segments of the airway, approximation and anastomosis of the two intact ends by means of fine synthetic absorbable sutures with minimum tension. Steroids with anti-inflammatory effect widely use as first line therapy for this condition.

Patients who underwent resection anastomosis during 2014-2016 for treatment of post-intubation tracheal stenosis will be included in this study. Systemic prednisolone will be used for treatment and prevention of recurrent tracheal stenosis in post-operative patients. Post-operative patients will divide in two groups, one of them will receive prednisolone and the other will receive placebo for 30 days. The results will be compared by bronchoscopy (FOB or rigid) after 30 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion criteria:

1. Post-operative resection anastomosis patients.

2. Age more than 10 years old.

3. no severe tension in surgery by the opinion of surgeon.

Exclusion Criteria:

1. Pregnancy

2. History of significant medical condition not controlled by medicines. Ex:

cardiovascular diseases, endocrine impairments and etc.

3. Weight is =200% ideal body weight

4. Severe chronic liver disease

5. immunosuppression including HIV+ status, history of bone marrow or solid organ transplantation, current malignancy, neutropenia

6. Fungal systemic infection

Related Conditions & MeSH terms

• Constriction, Pathologic
• Tracheal Stenosis

Intervention

Drug:
• Prednisolone

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Research Institute of Tuberculosis and Lung Disease, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	inflammation	achieved by fiber optic bronchoscopy (FOB) and surgeon judged the principal etiology of recurrence of an inflammatory process in the anastomosis site which results in development of fibrotic tissue.	30 days
Other	Partial and complete dehiscence with or without infection	patients referent hospital emergency, cause of breathing problems and re intubation must needed.	30 days
Primary	Completely wound healing.	achieved by fiber optic bronchoscopy (FOB) and a surgeon judged that the patients were with out any sign of clinical symptoms of upper respiratory tract stenosis postoperatively and anastomosis site was with out any presence of stenosis (fibrous tissue), granulation tissue formation and inflamed mucosa.	30 days
Secondary	Granulation tissue formation without visible dehiscence	achieved by fiber optic bronchoscopy (FOB) and a surgeon judged about production of fibrotic and excess granulation tissue at the site of anastomosis during FOB.	30 days