Can Recurrence of Hamartomas be Prevented?
Primary Purpose
Airway Obstruction, Hamartoma of Lung
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endobronchial hamartomas treatment
Sponsored by
About this trial
This is an interventional treatment trial for Airway Obstruction focused on measuring Hamartoma, Cryotherapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Endobronchial hamartomas treatment
Arm Description
After removal of endobronchial lesions, cryotherapy is applied to the area of origin. Recurrences are followed. Recurrences are recorded as poor results, compared with good results.
Outcomes
Primary Outcome Measures
Recurrences
Follow up recurrences
Secondary Outcome Measures
Full Information
NCT ID
NCT03604055
First Posted
July 11, 2018
Last Updated
July 27, 2018
Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03604055
Brief Title
Can Recurrence of Hamartomas be Prevented?
Official Title
Can we Prevent Recurrences in the Endoscopic Treatment of Endobronchial Hamartomas?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction, Hamartoma of Lung
Keywords
Hamartoma, Cryotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endobronchial hamartomas treatment
Arm Type
Other
Arm Description
After removal of endobronchial lesions, cryotherapy is applied to the area of origin. Recurrences are followed. Recurrences are recorded as poor results, compared with good results.
Intervention Type
Procedure
Intervention Name(s)
Endobronchial hamartomas treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Recurrences
Description
Follow up recurrences
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Can Recurrence of Hamartomas be Prevented?
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