Medical Thoracoscopy Versus Tube Thoracostomy in Management of Empyema .

Empyema Clinical Trial

Official title:

A Comparative Study : Medical Thoracoscopy Versus Tube Thoracostomy in Early Management of Empyema .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03859206
• Other study ID #: medical thoracoscopy empyema
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: shahenda mohammed gamal el din, MD
• Phone: 01009190918
• Email: elkadyshahenda[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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) .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. unilateral or bilateral frank pleural empyema (pus) .

2. age > 18 and <70 years old

Exclusion Criteria:

1. Transudative pleural effusion.

2. Bleeding disorders.

3. Hemo-dynamically unstable patients.

4. General contraindications to thoracoscopy e.g. unstable angina, left ventricular failure, uncontrolled hypertension, bleeding tendency. . .etc.

5. Recent history of chest trauma or proved hemothorax.

Related Conditions & MeSH terms

• Empyema

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Brutsche MH, Tassi GF, Györik S, Gökcimen M, Renard C, Marchetti GP, Tschopp JM. Treatment of sonographically stratified multiloculated thoracic empyema by medical thoracoscopy. Chest. 2005 Nov;128(5):3303-9. — View Citation

Redden MD, Chin TY, van Driel ML. Surgical versus non-surgical management for pleural empyema. Cochrane Database Syst Rev. 2017 Mar 17;3:CD010651. doi: 10.1002/14651858.CD010651.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	up to 14 days .
Secondary	Duration of hospital stay	Reduction in hospital stay in group with medical thoracoscopy in comparison to the group with simple chest tube	up to 14 day .
Secondary	Adverse events	such as bleeding , sever pain , persistence air leak	within 24 hour after medical thoracoscopy