Medical Thoracoscopy Versus Tube Thoracostomy in Management of Empyema .
A Comparative Study : Medical Thoracoscopy Versus Tube Thoracostomy in Early Management of Empyema .
1 other identifier
interventional
60
0 countries
N/A
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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMarch 5, 2019
March 1, 2019
2 years
February 19, 2019
March 1, 2019
Conditions
Keywords
Outcome Measures
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 .
up to 14 days .
Secondary Outcomes (2)
Duration of hospital stay
up to 14 day .
Adverse events
within 24 hour after medical thoracoscopy
Study Arms (2)
empyema patients having medical thoracoscopy
EXPERIMENTALpatients 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
tube thoracostomy in patients with empyema
NO INTERVENTIONafter 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
• 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.
Eligibility Criteria
You may qualify if:
- unilateral or bilateral frank pleural empyema (pus) .
- age \> 18 and \<70 years old
You may not qualify if:
- Transudative pleural effusion.
- Bleeding disorders.
- Hemo-dynamically unstable patients.
- General contraindications to thoracoscopy e.g. unstable angina, left ventricular failure, uncontrolled hypertension, bleeding tendency. . .etc.
- Recent history of chest trauma or proved hemothorax.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 28304084BACKGROUNDBrutsche 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.
PMID: 16304276BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer , chest department and tuberculosis
Study Record Dates
First Submitted
February 19, 2019
First Posted
March 1, 2019
Study Start
March 1, 2019
Primary Completion
March 1, 2021
Study Completion
May 1, 2021
Last Updated
March 5, 2019
Record last verified: 2019-03