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Medical Thoracoscopy Versus Tube Thoracostomy in Management of Empyema .

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ClinicalTrials.gov Identifier: NCT03859206
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
shahenda mohammed gamal el din, Assiut University

Brief 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) .


Condition or disease Intervention/treatment Phase
Empyema Other: Medical thoracoscopy Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Comparative Study : Medical Thoracoscopy Versus Tube Thoracostomy in Early Management of Empyema .
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
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
• 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.

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.



Primary Outcome Measures :
  1. 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 .


Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: up to 14 day . ]
    Reduction in hospital stay in group with medical thoracoscopy in comparison to the group with simple chest tube

  2. Adverse events [ Time Frame: within 24 hour after medical thoracoscopy ]
    such as bleeding , sever pain , persistence air leak



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859206


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

Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: shahenda mohammed gamal el din, assistant lecturer , chest department and tuberculosis, Assiut University
ClinicalTrials.gov Identifier: NCT03859206    
Other Study ID Numbers: medical thoracoscopy empyema
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by shahenda mohammed gamal el din, Assiut University:
medical
Thoracoscopy
loculated
empyema
Additional relevant MeSH terms:
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Empyema
Suppuration
Infection
Inflammation
Pathologic Processes