EmpyemaNCT03859206
Medical Thoracoscopy Versus Tube Thoracostomy in Management of Empyema .
A study testing Medical thoracoscopy in people with Empyema, run by Assiut University.
Trial summary
Pleural empyema : is a collection of pus in the pleural cavity caused by microorganisms, usually bacteria.[1] Medical thoracoscopy has played a marginal role in the treatment of empyema for a long time, but has become more and more established in recent years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Empyema
- What is being tested?
- Medical thoracoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral or bilateral frank pleural empyema (pus) .
- age > 18 and <70 years old
Who cannot join
- Transudative pleural effusion.
- Bleeding disorders.
- Hemo-dynamically unstable patients.
- General contraindications to thoracoscopy e.g. unstable angina, left ventricular failure, uncontrolled hypertension, bleeding tendency. . .etc.
- Recent history of chest trauma or proved hemothorax.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Study : Medical Thoracoscopy Versus Tube Thoracostomy in Early Management of Empyema .
Pleural empyema : is a collection of pus in the pleural cavity caused by microorganisms, usually bacteria.[1]
Medical thoracoscopy has played a marginal role in the treatment of empyema for a long time, but has become more and more established in recent years. It can be per-formed in analgo-sedation in a bronchoscopy suite. It is minimally invasive and costs are much lower compared to surgical VATS. The diagnostic and therapeutic power seems to be comparable to VATS, since several studies show success rates with medical thoracoscopy between 73 and 100% (2, 3) .
Read the detailed description
Study Setting: Assuit university hospital - Chest department. endoscopy unit . the subjects will under go the following :
- Thorough medical history .
- Routine hematologic investigations .
- Pleural fluid aspiration and analyses . .
- Radiological investigation \& Chest X ray and CT scan to localize pleural fluid collection and assess the echogenicity of the effusion. \& Chest ultrasound. Loculated empyema defined as ultrasonographic presence of empyema loculations with presence of intrapleural septa.
- Medical thoracoscopy (MT):
Medical thoracoscopy with single-port-of-entry technique will be performed in the bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg) or bethdein.
- To define the point of entry into the pleural cavity, an ultrasound will be carried out.
- vertical incision will be made with the scalpel (usually near the midaxillary line), through the skin and subcutaneous tissue, appropriate to the size of the trocar to be used, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space.
- Then the trocar will be inserted in a corkscrew motion until the sudden release of resistance (after passing the costal pleura) is felt, while holding the handle of the trocar firmly in the palm of the hand, as index finger is extended.
- Under direct vision with the thoracoscope, introduction of pneumothorax will be performed, and all pleural fluid will be removed, and the pleural cavity will be inspected.
- With the closed biopsy forceps, step by step, fibrinous septae were perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken \& If no lesion, biopsy from parietal pleura was obtained from any sites.
- \& Following thoracoscopy, a chest tube (gauge 26-28) was introduced and connected to underwater seal. The wound was then closed around the tube by stitches to fix it in position.
- \& After the procedure, chest X- ray PA view was done to show if any complications had happened and to insure inflation of the lung, to determine the size of the residual pneumothorax.
- Vital signs were recorded at appropriate intervals for 24 h. \& The rigid thoracoscope and its accessories were sterilized by cold immersion in 2% gultraldhyde (cidex) for at least 30 min.
- An intercostal drain will be placed with underwater seal drainage to drain residual air and fluid from the pleural cavity, allowing the lung to re expand.
- The indications for removal of chest tubes will be absence of air leakage and cessation of fluid flow (100-150 mL daily).
- The patients who would be diagnosed will be blindly randomized to the two study arms : medical thoracoscopy or tube thoracostomy .
- Conditions
- Empyema
- Being tested
- Medical thoracoscopy
- Keywords
- medical, Thoracoscopy, loculated, empyema
- Medical subject headings
- Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical thoracoscopyOther
- With the closed biopsy forceps, step by step, fibrinous septae were perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken \& If no lesion, biopsy from parietal pleura was obtained from any sites.
| Study group | Role | What they receive |
|---|---|---|
| empyema patients having medical thoracoscopy | Experimental | patients having empyema will undergo medical thoracoscopy as follow :
With the closed biopsy forceps, step by step, fibrinous septae will be perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken \& If no lesion, biopsy from parietal pleura was obtained from any sites.
the intervention : is breaking the septation within the loculated empyema Receives: Other: Medical thoracoscopy |
| tube thoracostomy in patients with empyema | No intervention | after confirmation of diagnosis of empyema Following , a chest tube (gauge 26-28) will be introduced and connected to underwater seal. The wound was then closed around the tube by stitches to fix it in position. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical cure without secondary Intervention
medical cure will be defined as radiologic confirmation of successful pleural drainage (i.e. reduction of the size of the pleural fluid on the chest X-ray and chest ultrasound )with no need for further treatment by r surgical interventions) objective evidence of sepsis resolution (improvement in temperature and clinical condition and decreasing inflammatory laboratory markers .and decrease of amount of fluid discharge less than (50-100)cc per day .
Measured: up to 14 days .
Secondary outcomes (2)
Duration of hospital stay
Reduction in hospital stay in group with medical thoracoscopy in comparison to the group with simple chest tube
Measured: up to 14 day .
Adverse events
such as bleeding , sever pain , persistence air leak
Measured: within 24 hour after medical thoracoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EmpyemaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shahenda mohammed gamal el din, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859206
- Sponsor's protocol ID
- medical thoracoscopy empyema
- Status last verified
- Mar 2019
- First submitted
- 19 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Redden MD, Chin TY, van Driel ML. Surgical versus non-surgical management for pleural empyema. Cochrane Database Syst Rev. 2017 Mar 17;3(3):CD010651. doi: 10.1002/14651858.CD010651.pub2.
PubMed 28304084Brutsche MH, Tassi GF, Gyorik S, Gokcimen M, Renard C, Marchetti GP, Tschopp JM. Treatment of sonographically stratified multiloculated thoracic empyema by medical thoracoscopy. Chest. 2005 Nov;128(5):3303-9. doi: 10.1378/chest.128.5.3303.
PubMed 16304276
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study : Medical Thoracoscopy Versus Tube Thoracostomy in Early Management of Empyema .
- ClinicalTrials.gov ID
- NCT03859206
- Acronym / sponsor ID
- medical thoracoscopy empyema
- Conditions
- Empyema
- Keywords
- medical, Thoracoscopy, loculated, empyema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pleural empyema : is a collection of pus in the pleural cavity caused by microorganisms, usually bacteria.[1]
Medical thoracoscopy has played a marginal role in the treatment of empyema for a long time, but has become more and more established in recent years. It can be per-formed in analgo-sedation in a bronchoscopy suite. It is minimally invasive and costs are much lower compared to surgical VATS. The diagnostic and therapeutic power seems to be comparable to VATS, since several studies show success rates with medical thoracoscopy between 73 and 100% (2, 3) .
Detailed description
Study Setting: Assuit university hospital - Chest department. endoscopy unit . the subjects will under go the following :
- Thorough medical history .
- Routine hematologic investigations .
- Pleural fluid aspiration and analyses . .
- Radiological investigation \& Chest X ray and CT scan to localize pleural fluid collection and assess the echogenicity of the effusion. \& Chest ultrasound. Loculated empyema defined as ultrasonographic presence of empyema loculations with presence of intrapleural septa.
- Medical thoracoscopy (MT):
Medical thoracoscopy with single-port-of-entry technique will be performed in the bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg) or bethdein.
- To define the point of entry into the pleural cavity, an ultrasound will be carried out.
- vertical incision will be made with the scalpel (usually near the midaxillary line), through the skin and subcutaneous tissue, appropriate to the size of the trocar to be used, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space.
- Then the trocar will be inserted in a corkscrew motion until the sudden release of resistance (after passing the costal pleura) is felt, while holding the handle of the trocar firmly in the palm of the hand, as index finger is extended.
- Under direct vision with the thoracoscope, introduction of pneumothorax will be performed, and all pleural fluid will be removed, and the pleural cavity will be inspected.
- With the closed biopsy forceps, step by step, fibrinous septae were perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken \& If no lesion, biopsy from parietal pleura was obtained from any sites.
- \& Following thoracoscopy, a chest tube (gauge 26-28) was introduced and connected to underwater seal. The wound was then closed around the tube by stitches to fix it in position.
- \& After the procedure, chest X- ray PA view was done to show if any complications had happened and to insure inflation of the lung, to determine the size of the residual pneumothorax.
- Vital signs were recorded at appropriate intervals for 24 h. \& The rigid thoracoscope and its accessories were sterilized by cold immersion in 2% gultraldhyde (cidex) for at least 30 min.
- An intercostal drain will be placed with underwater seal drainage to drain residual air and fluid from the pleural cavity, allowing the lung to re expand.
- The indications for removal of chest tubes will be absence of air leakage and cessation of fluid flow (100-150 mL daily).
- The patients who would be diagnosed will be blindly randomized to the two study arms : medical thoracoscopy or tube thoracostomy .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empyema patients having medical thoracoscopy | Experimental | Other: Medical thoracoscopypatients having empyema will undergo medical thoracoscopy as follow : With the closed biopsy forceps, step by step, fibrinous septae will be perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken \& If no lesion, biopsy from parietal pleura was obtained from any sites. the intervention : is breaking the septation within the loculated empyema |
| tube thoracostomy in patients with empyema | No intervention | –after confirmation of diagnosis of empyema Following , a chest tube (gauge 26-28) will be introduced and connected to underwater seal. The wound was then closed around the tube by stitches to fix it in position. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral or bilateral frank pleural empyema (pus) .
- age > 18 and <70 years old
Key exclusion criteria (5 listed)
- Transudative pleural effusion.
- Bleeding disorders.
- Hemo-dynamically unstable patients.
- General contraindications to thoracoscopy e.g. unstable angina, left ventricular failure, uncontrolled hypertension, bleeding tendency. . .etc.
- Recent history of chest trauma or proved hemothorax.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical thoracoscopy• With the closed biopsy forceps, step by step, fibrinous septae were perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken \& If no lesion, biopsy from parietal pleura was obtained from any sites. | Other | empyema patients having medical thoracoscopy |
Primary outcome
Medical cure without secondary Intervention
Time frame: up to 14 days .
medical cure will be defined as radiologic confirmation of successful pleural drainage (i.e. reduction of the size of the pleural fluid on the chest X-ray and chest ultrasound )with no need for further treatment by r surgical interventions) objective evidence of sepsis resolution (improvement in temperature and clinical condition and decreasing inflammatory laboratory markers .and decrease of amount of fluid discharge less than (50-100)cc per day .
2 secondary outcomes
Duration of hospital stay
Time frame: up to 14 day .
Adverse events
Time frame: within 24 hour after medical thoracoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Background: PubMed 28304084Redden MD, Chin TY, van Driel ML. Surgical versus non-surgical management for pleural empyema. Cochrane Database Syst Rev. 2017 Mar 17;3(3):CD010651. doi: 10.1002/14651858.CD010651.pub2.
- Background: PubMed 16304276Brutsche MH, Tassi GF, Gyorik S, Gokcimen M, Renard C, Marchetti GP, Tschopp JM. Treatment of sonographically stratified multiloculated thoracic empyema by medical thoracoscopy. Chest. 2005 Nov;128(5):3303-9. doi: 10.1378/chest.128.5.3303.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Medical thoracoscopy in people with Empyema, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shahenda mohammed gamal el din, MD (01009190918, elkadyshahenda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical cure without secondary Intervention (time frame: up to 14 days .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03859206, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.