ClinicalTrials.gg
Status unknownNCT03859206Updated Mar 5, 2019

Medical Thoracoscopy Versus Tube Thoracostomy in Management of Empyema .

An interventional study of Medical thoracoscopy in Empyema, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Assiut University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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 :

  1. Thorough medical history .
  2. Routine hematologic investigations .
  3. Pleural fluid aspiration and analyses .

    .

  4. 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.
  5. 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 .

02

Conditions studied

  • Empyema

Browse trials for

Keywords

  • medical
  • Thoracoscopy
  • loculated
  • empyema
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 60 is below the median of 92 across 28 interventional studies indexed under Empyema.

Browse Empyema studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

  1. unilateral or bilateral frank pleural empyema (pus) .
  2. age > 18 and \<70 years old

Exclusion criteria

Exclusion Criteria:

  1. Transudative pleural effusion.
  2. Bleeding disorders.
  3. Hemo-dynamically unstable patients.
  4. General to thoracoscopy e.g. unstable angina, left ventricular failure, uncontrolled hypertension, bleeding tendency. . .etc.
  5. Recent history of chest trauma or proved hemothorax.
Terms in these criteria, in plain language(1)

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.

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
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    empyema patients having medical thoracoscopy

    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

    Other: Medical thoracoscopy

  • No intervention
    tube thoracostomy in patients with empyema

    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.

Interventions

  • OtherMedical 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.

06

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: up to 14 days .

Secondary outcomes

  1. Duration of hospital stay

    Reduction in hospital stay in group with medical thoracoscopy in comparison to the group with simple chest tube

    Time frame: up to 14 day .

  2. Adverse events

    such as bleeding , sever pain , persistence air leak

    Time frame: within 24 hour after medical thoracoscopy

07

Study locations

No study locations are listed for this record.

08

References and documents

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 28304084 ↗
  • Brutsche 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03859206
Lead sponsor
Assiut University
Responsible party
shahenda mohammed gamal el din (assistant lecturer , chest department and tuberculosis, Assiut University) — Principal investigator
First posted
Mar 1, 2019
Start date
Mar 1, 2019 (estimated)
Primary completion
Mar 1, 2021 (estimated)
Completion
May 1, 2021 (estimated)
Last update
Mar 5, 2019

Study contacts

shahenda mohammed gamal el din, MD
Contact
elkadyshahenda@yahoo.com
01009190918
Mohamed M.Reda Abdelaziz, MD
Contact
m_reda306@yahoo.com
01007041335

Oversight

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

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