Can Recurrence of Hamartomas be Prevented?

July 27, 2018 updated by: Zafer Aktaş, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Endobronchial hamartomas treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrences
Time Frame: 36 months
Follow up recurrences
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Za1238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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