ClinicalTrials.gg
Not yet recruitingNCT06132997Updated Nov 15, 2023

Medical Thoracoscopy in Treatment Outcomes of Empyema Management

An interventional study of Thoracoscopy procedure and Chest tube thoracostomy in Empyema, sponsored by Hend Mohamed Sayed Mohamed. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Hend Mohamed Sayed Mohamed · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Empyema

Browse trials for

03

In context

Empyema

38 studies on the registry are indexed under Empyema; 11 are open to participants now.

This study's planned enrollment of 100 is close to the median of 92 across 28 interventional studies indexed under Empyema.

Browse Empyema studies →

Lead sponsor

This is the only study on the registry with Hend Mohamed Sayed Mohamed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Age less than 18 years
  • state or other conditions to thoracoscopy
  • Previous drainage procedure for current Empyema
  • Residual pleural fluid not amenable to drain
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Medical thoracoscopy group

    Medical thoracoscopy is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions.

    Procedure: Thoracoscopy procedure · Procedure: Chest tube thoracostomy

  • Active comparator
    Intercostal tube group

    Intercostal chest tube placed without thoracoscopy for patients with confirmed empyema.

    Procedure: Thoracoscopy procedure · Procedure: Chest tube thoracostomy

Interventions

  • ProcedureThoracoscopy procedure

    is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions.

  • ProcedureChest tube thoracostomy

    Insert chest intercostal tube without thoracoscopy

06

What researchers measure

Primary outcomes

  1. Treatment success:

    Asses by chest ultrasound

    Time frame: baseline

Secondary outcomes

  1. Success of pleurodesis

    measured by assessing the recurrence rate of pleural effusion over a specified follow-up period.

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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 31525811 ↗
  • Aboudara 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06132997
Lead sponsor
Hend Mohamed Sayed Mohamed
Responsible party
Hend Mohamed Sayed Mohamed (Principal investigator, Assiut University) — Sponsor-investigator
First posted
Nov 15, 2023
Start date
Dec 24, 2023 (estimated)
Primary completion
Dec 28, 2024 (estimated)
Completion
Mar 24, 2025 (estimated)
Last update
Nov 15, 2023

Study contacts

Hend saleh, MD
Contact
hend.m.saleh@gmail.com
01098988712
Mohamed yassen, MD
Contact
Mfawzy2013@hotmail.com
0100680052
Mustafa Ahmed, MD
study chair · Doctor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion