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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
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Obstruction focused on measuring Hamartoma, Cryotherapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 11, 2018
    Last Updated
    July 27, 2018
    Sponsor
    Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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    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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