Can Recurrence of Hamartomas be Prevented?

Airway Obstruction Clinical Trial

Official title:

Can we Prevent Recurrences in the Endoscopic Treatment of Endobronchial Hamartomas?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604055
• Other study ID #: Za1238
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital Pulmonary Rehabilitation and Home Care Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background. Recently, treatment of endobronchial hamartomas with interventional bronchoscopic methods has become possible. Although there are several reports of therapeutic benefits, the protocol of administration varies between centers and high recurrence rates continue to be a problem. In this study, the investigators aimed to show that cryotherapy applied to the root of the bronchial wall after removal of the intraluminal portion of endobronchial hamartoma with interventional bronchoscopic methods can prevent recurrences.

Methods. Between 2012 and 2016, the treatment outcomes and long-term follow-up data of 21 consecutive patients with symptomatic endobronchial hamartomas treated by interventional bronchoscopic methods were prospectively recorded. After debulking, cryotherapy was applied to the root of the bronchial wall of all lesions. The data were analyzed retrospectively.

Description:

Introduction:

Hamartomas are the most common benign pulmonary tumors. The incidence varies between 0.025% and 0.032%. Endobronchial hamartomas constitute 10-20% of all pulmonary hamartomas. Pulmonary hamartomas are usually asymptomatic and are diagnosed incidentally. In endobronchial hamartomas, at least one of the symptoms of airway obstruction such as cough, hemoptysis and dyspnea are most commonly seen (80%). The results of bronchoscopic removal of symptomatic endobronchial hamartomas and recurrence rates have been the subject of several studies.

Cryotherapy is an endobronchial therapy based on the cytotoxic effects of extreme cold on tumor tissues. Excessive cold causes intracellular and extracellular ice crystals to form in the affected tissue. These crystals damage intracellular organelles, especially mitochondria. The most lethal effect is the formation of intracellular ice crystals. This effect results from fast freezing and slow thawing cycles. In clinical practice, cryotherapy is used as an endobronchial treatment method capable of destroying tumor cells at a depth of 10 mm with a rigid probe and at a depth of 3 mm with a flexible probe.

The investigators investigated the treatment and long-term follow-up results of patients who underwent cryotherapy to the site of origin on the airway wall after the luminal part of the symptomatic endobronchial hamartomas was removed by interventional bronchoscopic methods. We aimed to determine the benefit of cryotherapy to conventional endobronchial debulking at the sites of origin of hamartomas.

Material and Methods:

General anesthesia was administered by an intravenous anesthesia technique. Patients were intubated with a rigid bronchoscope (Effer-Dumon, 11 mm diameter, 43 cm length, Efer Endoscopy, Marseille, France). Debulking procedures were performed by mechanical tumor resection (MTR) using the tip of the rigid bronchoscope, rigid pliers or argon plasma coagulation assisted MTR (ERBE ICC 200/APC 300 electrosurgical unit, rigid APC probe, 50 cm length, 2.3 mm diameter; ERBE, Medizintechnik, GmbH, Tübingen, Germany) or cryorecanalization (ERBOKRYO® CA unit, ERBE flexible cryoprobe 2.4 mm diameter, 90 cm length or ERBE rigid cryoprobe 3 mm diameter, 53 cm length; ERBE, Medizintechnik, GmbH, Tübingen, Germany) or electrocautery - snare probe (Erbotom ICC 200 electrosurgical unit ERBE, Medizintechnik GmbH, Tübingen, Germany and Electrosurgical snare probe SD-7C-1, loop diameter 23 mm, length 1050 mm, Olympus EndoTherapy, Tokyo, Japan). An innovation of study was that cryotherapy (Using the same equipment as cryorecanalization) was performed in the regions where the lesions originated after debulking.

Descriptive statistics were expressed as the mean ± standard deviation for intermittent and continuous numerical variables, and categorical variables were expressed as number of cases and "(%)".

This study has been approved by the local ethics committee. Informed consent was obtained from all patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with symptomatic endobronchial hamartomas treated by interventional bronchoscopic methods.

Exclusion Criteria:

• Patients with coagulation anomalies or low platelet counts, pregnancy, or who were younger than 18 years of age and those who did not sign the informed consent were excluded from the study

Related Conditions & MeSH terms

• Airway Obstruction
• Hamartoma of Lung
• Recurrence

Intervention

Procedure:
• Endobronchial hamartomas treatment
General anesthesia was administered by an intravenous anesthesia technique. Patients were intubated with a rigid bronchoscope. Debulking procedures were performed by mechanical tumor resection (MTR) using the tip of the rigid bronchoscope, rigid pliers or argon plasma coagulation assisted MTR or cryorecanalization or electrocautery - snare probe. An innovation of our study was that cryotherapy was performed in the regions where the lesions originated after debulking

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital Pulmonary Rehabilitation and Home Care Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrences	Follow up recurrences	36 months