EmpyemaNCT06132997
Medical Thoracoscopy in Treatment Outcomes of Empyema Management
A study testing Thoracoscopy procedure and Chest tube thoracostomy in people with Empyema, run by Hend Mohamed Sayed Mohamed.
Trial summary
To evaluate the efficacy of drainage achieved by thoracoscopy vs tube drainage alone. To compare clinical outcomes such as length of hospital stay, need for additional procedures, and treatment failure rates between the two drainage methods. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Empyema
- What is being tested?
- Thoracoscopy procedure and Chest tube thoracostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 24 Dec 2023to 24 Mar 2025
- 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
- Confirmed diagnosis of empyema via Imaging tests (e.g. chest x-ray/CT scan)
- Age 18 years or older
- Clinical signs/symptoms consistent with Empyema such as fever, chest pain, coughs
- Pleural fluid loculations/septations seen on Imaging requiring drainage
- No previous drainage procedures done for Current empyema
Who cannot join
- Age less than 18 years
- Immunocompromised state or other conditions Contraindications to thoracoscopy
- Previous drainage procedure for current Empyema
- Residual pleural fluid not amenable to drain
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Medical Thoracoscopy Versus Conventional Intercostal Tube in Treatment Outcomes of Empyema Management
To evaluate the efficacy of drainage achieved by thoracoscopy vs tube drainage alone.
To compare clinical outcomes such as length of hospital stay, need for additional procedures, and treatment failure rates between the two drainage methods.
To asses resolution of pleural infection and rates of fluid re-accumulation over follow-up.
To compare safety profiles and complication rates of thoracoscopy versus tube drainage alone
Read the detailed description
Empyema is a serious infection characterized by pus accumulation in the pleural space. Effective drainage and treatment is necessary for resolution. Traditionally, intercostal tube placement was standard initial management. However, recent studies have compared outcomes of early medical thoracoscopy or video-assisted thoracoscopic surgery (VATS).
Thoracoscopy enables direct visualization for thorough pleural space cleansing and debridement under direct vision. medical thoracoscopy significantly improved drainage adequacy and reduced treatment failure risks compared to tube drainage alone. Also reported shorter hospital stays and lower complication rates with early thoracoscopy-directed management.
Additional benefits of thoracoscopy include enabling talc pleurodesis for reducing empyema recurrence. thoracoscopy-directed pleurodesis achieved higher long-term success rates than tube drainage followed by pleurodesis. Overall, current evidence indicates medical thoracoscopy provides superior empyema treatment outcomes to conventional tube drainage through optimized drainage and debridement under direct visualization.
- Conditions
- Empyema
- Being tested
- Thoracoscopy procedure, Chest tube thoracostomy
- Medical subject headings
- Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopy procedureProcedure or surgery
is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions.
Chest tube thoracostomyProcedure or surgery
Insert chest intercostal tube without thoracoscopy
| Study group | Role | What they receive |
|---|---|---|
| Medical thoracoscopy group | Active comparator | Medical thoracoscopy is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions. Receives: Procedure: Thoracoscopy procedure; Procedure: Chest tube thoracostomy |
| Intercostal tube group | Active comparator | Intercostal chest tube placed without thoracoscopy for patients with confirmed empyema. Receives: Procedure: Thoracoscopy procedure; Procedure: Chest tube thoracostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success:
Asses by chest ultrasound
Measured: baseline
Secondary outcomes (1)
Success of pleurodesis
measured by assessing the recurrence rate of pleural effusion over a specified follow-up period.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start24 Dec 2023 (estimated)
- Primary completion28 Dec 2024 (estimated)
- Study completion24 Mar 2025 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Medical thoracoscopy group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hend Mohamed Sayed Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hend Mohamed Sayed Mohamed, Assiut University
- Investigators
- Mustafa Ahmed, MD, Study chair, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132997
- Sponsor's protocol ID
- Medical thoracoscopy&Empyem
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Godfrey MS, Bramley KT, Detterbeck F. Medical and Surgical Management of Empyema. Semin Respir Crit Care Med. 2019 Jun;40(3):361-374. doi: 10.1055/s-0039-1694699. Epub 2019 Sep 16.
PubMed 31525811Aboudara M, Maldonado F. Update in the Management of Pleural Effusions. Med Clin North Am. 2019 May;103(3):475-485. doi: 10.1016/j.mcna.2018.12.007.
PubMed 30955515
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Thoracoscopy Versus Conventional Intercostal Tube in Treatment Outcomes of Empyema Management
- ClinicalTrials.gov ID
- NCT06132997
- Acronym / sponsor ID
- Medical thoracoscopy&Empyem
- Conditions
- Empyema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hend Mohamed Sayed MohamedUniversity, hospital or other
- Study start
- 24 Dec 2023 (estimated)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 24 Mar 2025 (estimated)
- First posted
- 15 Nov 2023 (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.
To evaluate the efficacy of drainage achieved by thoracoscopy vs tube drainage alone.
To compare clinical outcomes such as length of hospital stay, need for additional procedures, and treatment failure rates between the two drainage methods.
To asses resolution of pleural infection and rates of fluid re-accumulation over follow-up.
To compare safety profiles and complication rates of thoracoscopy versus tube drainage alone
Detailed description
Empyema is a serious infection characterized by pus accumulation in the pleural space. Effective drainage and treatment is necessary for resolution. Traditionally, intercostal tube placement was standard initial management. However, recent studies have compared outcomes of early medical thoracoscopy or video-assisted thoracoscopic surgery (VATS).
Thoracoscopy enables direct visualization for thorough pleural space cleansing and debridement under direct vision. medical thoracoscopy significantly improved drainage adequacy and reduced treatment failure risks compared to tube drainage alone. Also reported shorter hospital stays and lower complication rates with early thoracoscopy-directed management.
Additional benefits of thoracoscopy include enabling talc pleurodesis for reducing empyema recurrence. thoracoscopy-directed pleurodesis achieved higher long-term success rates than tube drainage followed by pleurodesis. Overall, current evidence indicates medical thoracoscopy provides superior empyema treatment outcomes to conventional tube drainage through optimized drainage and debridement under direct visualization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Medical thoracoscopy group
| Arm | Type | Receives |
|---|---|---|
| Medical thoracoscopy group | Active comparator | Procedure: Thoracoscopy procedure, Procedure: Chest tube thoracostomyMedical thoracoscopy is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions. |
| Intercostal tube group | Active comparator | Procedure: Thoracoscopy procedure, Procedure: Chest tube thoracostomyIntercostal chest tube placed without thoracoscopy for patients with confirmed empyema. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of empyema via Imaging tests (e.g. chest x-ray/CT scan)
- Age 18 years or older
- Clinical signs/symptoms consistent with Empyema such as fever, chest pain, coughs
- Pleural fluid loculations/septations seen on Imaging requiring drainage
- No previous drainage procedures done for Current empyema
Key exclusion criteria (4 listed)
- Age less than 18 years
- Immunocompromised state or other conditions Contraindications to thoracoscopy
- Previous drainage procedure for current Empyema
- Residual pleural fluid not amenable to drain
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 |
|---|---|---|
| Thoracoscopy procedureis a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions. | Procedure or surgery | Intercostal tube group, Medical thoracoscopy group |
| Chest tube thoracostomyInsert chest intercostal tube without thoracoscopy | Procedure or surgery | Intercostal tube group, Medical thoracoscopy group |
Primary outcome
Treatment success:
Time frame: baseline
Asses by chest ultrasound
1 secondary outcome
Success of pleurodesis
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Background: PubMed 31525811Godfrey MS, Bramley KT, Detterbeck F. Medical and Surgical Management of Empyema. Semin Respir Crit Care Med. 2019 Jun;40(3):361-374. doi: 10.1055/s-0039-1694699. Epub 2019 Sep 16.
- Background: PubMed 30955515Aboudara M, Maldonado F. Update in the Management of Pleural Effusions. Med Clin North Am. 2019 May;103(3):475-485. doi: 10.1016/j.mcna.2018.12.007.
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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.
Mustafa Ahmed, MD study chair
Doctor
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoscopy procedure and Chest tube thoracostomy in people with Empyema, run by Hend Mohamed Sayed Mohamed.
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 5 inclusion and 4 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 15 Nov 2023. 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 Hend saleh, MD (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success: (time frame: baseline). 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 NCT06132997, 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 15 Nov 2023.