Pericardial EffusionNCT05061914
Surgical Options for Management of Pericardial Effusion
A study testing pericardial effusion drainage in people with Pericardial Effusion, run by Sohag University at 1 site in Egypt.
Trial summary
This is a retrospective descriptive study which will be conducted at Sohag university Hospital, Sohag, Egypt at emergency and cardiothoracic department . It includes all patients with pericardial effusion who diagnosed as temponading pericardial effusion or threatened cardiac temponade , The aim of this work is to… Read more about this study
- Who is it for?
- Ages 6 months to 80 years
- Conditions the study is for
- Pericardial Effusion
- What is being tested?
- pericardial effusion drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2016to 18 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suspected malignant effusion . Systemic collagen diseases e.g; SLE , Rheumatoid Artheritis …… Suspected cases of tuberculosis .
Who cannot join
- Cardiac tamponade as a complication of acute coronary syndromes Cardiac tamponade as a complication of aortic dissection . Pericardial effusion following penetrating and blunt chest trauma (heamopericardium).
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective descriptive study which will be conducted at Sohag university Hospital, Sohag, Egypt at emergency and cardiothoracic department . It includes all patients with pericardial effusion who diagnosed as temponading pericardial effusion or threatened cardiac temponade , The aim of this work is to clarify the suitability and individualization of each surgical procedure (either subxiphoidal drainage, drainage through thoracotomy or video-assisted thoracoscopic (VATS) pericardiotomy) in treatment and diagnosis of patients presenting with pericardial effusion .
Read the detailed description
The normal pericardial space contains up to 50 ml of fluid that formed of a plasma ultrafiltrate and the amount greater than this amount is considered as a pathologic effusion.
The curvilinear pressure-volume relationship of the pericardial sac leads to the consequences of the pericardial effusion specially the rapidly accumulating fluid that causes cardiac tamponade.
There is a lot of diseases and complications that vary in causing pericardial effusion e.g idiopathatic pericarditis, malignancy, connective tissue diseases and heamorrhage. The management of pericardial effusion depends on whether there is tamponade or not.
Despite the new diagnostic strategies and the recent data have improved our ability to assess the presence and the amount of pericardial effusion, and assess the cause and its heamodynamic impact, the optimal management of the pericardial effusion is still controversial. While the Echocardiography is the corner stone in the management, multimodal imaging strategies specially computed tomography are dependable. The optimal therapy for symptomatic pericardial effusions remains controversial. In general, there are surgical based approaches and percutaneous-based approaches to pericardial fluid drainage.
A surgical subxiphoid approach for draining a pericardial effusion was first described in 1829 and there have been several additional methods proposed for surgical pericardial effusion drainage since that time.
In 1986, Kopecky and colleagues reported the first percutaneous pericardiocentesis series with multiple subsequent reports characterizing the relative safety and efficacy of a percutaneous approach.
Initially, pericardial effusion is classified by the volume of effusion. The treatment is directed at the primary disease in patients with a small amount of effusion without symptoms. In contrast, pericardiocentesis is performed for patients who are vitally unstable and with a massive amount of effusion to prevent cardiac tamponade, Surgical drainage of pericardial effusion was classically conducted by either open thoracotomy or subxiphoid pericardiectomy.
Thoracoscopy has established itself as an alternative to open thoracotomy for the management of many pericardial, pleural and pulmonary disorders. Thoracoscopic cardiac procedures have been performed less frequently. It affords excellent visualization of the pericardial surface, thus allowing the safe performance of pericardial resection and formation of a pericardial window.
A pericardial window allows drainage of pericardial fluid into the adjacent space, usually the pleural cavity. The subxiphoid approach is erroneously referred to as a "window" because no connection is made to the adjacent space during the standard subxiphoid approach.
The thoracoscopic approach creates a true window but it is done under general anaesthesia with single-lung ventilation and through 2 or 3 intercostal ports. However, the role of the thoracoscopic approach is limited in patients with hemodynamically significant pericardial effusions due to the positioning of the patients in the lateral decubitus which makes emergency pericardiocentesis very difficult.
Recently , video-assisted thoracoscopic (VATS) pericardiotomy has gained popularity as a minimally invasive approach. VATS allows for visual evaluation of the pericardium and is used when the diagnosis of pericardial effusion has remained undiagnosed despite previous, less-invasive tests. It is also used to drain the excess fluid and prevent its reaccumulation.
Choosing the best surgical approach to drain the pericardial effusion is a matter of debate and it should be based upon the effectiveness of the approach in avoiding recurrence of the pericardial effusion and upon the morbidity and mortality associated with the procedure. Moreover, the relative simplicity of the procedure and its cost are other important aspects that should be considered when choosing the optimal surgical approach.
- Conditions
- Pericardial Effusion
- Being tested
- pericardial effusion drainage
- Medical subject headings
- Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pericardial effusion drainageProcedure or surgery
tamponading pericardial effusion is a life threatenning condition , pericardiocentesis is performed for patients who are vitally unstable and with a massive amount of effusion to prevent cardiac tamponade, Surgical drainage of pericardial effusion was classically conducted by either open thoracotomy or subxiphoid pericardiectomy. Thoracoscopy has established itself as an alternative to open thoracotomy for the management of many pericardial, pleural and pulmonary disorders
| Study group | Role | What they receive |
|---|---|---|
| pericardiocentesis | Active comparator | vitally unstable patients with tamponading pericardial effusion undergone percutaneous gradual drainage by a central venous catheter Receives: Procedure: pericardial effusion drainage |
| subxiphoiodal drainage | Active comparator | drainage of the pericardial effusion through a subxiphoidal midline incision Receives: Procedure: pericardial effusion drainage |
| thoracotomy | Active comparator | encysted and undiagnosed pericardial effusion drainage through anterior thoracotomy performing a pericardiopleural window and take a pericardial biopsy Receives: Procedure: pericardial effusion drainage |
| VATS drainage | Active comparator | encysted and undiagnosed pericardial effusion drainage through VATS that permits performing a pericardiopleural window and take a pericardial biopsy with minimal incisions Receives: Procedure: pericardial effusion drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
if there is a recurrence or not
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Mar 2016
- Primary completion18 Sep 2021
- Study completion18 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pericardial EffusionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Omar Ragheb, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061914
- Sponsor's protocol ID
- Soh-Med-21-09-04
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chiabrando JG, Bonaventura A, Vecchie A, Wohlford GF, Mauro AG, Jordan JH, Grizzard JD, Montecucco F, Berrocal DH, Brucato A, Imazio M, Abbate A. Management of Acute and Recurrent Pericarditis: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jan 7;75(1):76-92. doi: 10.1016/j.jacc.2019.11.021.
PubMed 31918837Saltzman AJ, Paz YE, Rene AG, Green P, Hassanin A, Argenziano MG, Rabbani L, Dangas G. Comparison of surgical pericardial drainage with percutaneous catheter drainage for pericardial effusion. J Invasive Cardiol. 2012 Nov;24(11):590-3.
PubMed 23117314Azarbal A, LeWinter MM. Pericardial Effusion. Cardiol Clin. 2017 Nov;35(4):515-524. doi: 10.1016/j.ccl.2017.07.005.
PubMed 29025543
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Options for Management of Pericardial Effusion
- ClinicalTrials.gov ID
- NCT05061914
- Acronym / sponsor ID
- Soh-Med-21-09-04
- Conditions
- Pericardial Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective descriptive study which will be conducted at Sohag university Hospital, Sohag, Egypt at emergency and cardiothoracic department . It includes all patients with pericardial effusion who diagnosed as temponading pericardial effusion or threatened cardiac temponade , The aim of this work is to clarify the suitability and individualization of each surgical procedure (either subxiphoidal drainage, drainage through thoracotomy or video-assisted thoracoscopic (VATS) pericardiotomy) in treatment and diagnosis of patients presenting with pericardial effusion .
Detailed description
The normal pericardial space contains up to 50 ml of fluid that formed of a plasma ultrafiltrate and the amount greater than this amount is considered as a pathologic effusion.
The curvilinear pressure-volume relationship of the pericardial sac leads to the consequences of the pericardial effusion specially the rapidly accumulating fluid that causes cardiac tamponade.
There is a lot of diseases and complications that vary in causing pericardial effusion e.g idiopathatic pericarditis, malignancy, connective tissue diseases and heamorrhage. The management of pericardial effusion depends on whether there is tamponade or not.
Despite the new diagnostic strategies and the recent data have improved our ability to assess the presence and the amount of pericardial effusion, and assess the cause and its heamodynamic impact, the optimal management of the pericardial effusion is still controversial. While the Echocardiography is the corner stone in the management, multimodal imaging strategies specially computed tomography are dependable. The optimal therapy for symptomatic pericardial effusions remains controversial. In general, there are surgical based approaches and percutaneous-based approaches to pericardial fluid drainage.
A surgical subxiphoid approach for draining a pericardial effusion was first described in 1829 and there have been several additional methods proposed for surgical pericardial effusion drainage since that time.
In 1986, Kopecky and colleagues reported the first percutaneous pericardiocentesis series with multiple subsequent reports characterizing the relative safety and efficacy of a percutaneous approach.
Initially, pericardial effusion is classified by the volume of effusion. The treatment is directed at the primary disease in patients with a small amount of effusion without symptoms. In contrast, pericardiocentesis is performed for patients who are vitally unstable and with a massive amount of effusion to prevent cardiac tamponade, Surgical drainage of pericardial effusion was classically conducted by either open thoracotomy or subxiphoid pericardiectomy.
Thoracoscopy has established itself as an alternative to open thoracotomy for the management of many pericardial, pleural and pulmonary disorders. Thoracoscopic cardiac procedures have been performed less frequently. It affords excellent visualization of the pericardial surface, thus allowing the safe performance of pericardial resection and formation of a pericardial window.
A pericardial window allows drainage of pericardial fluid into the adjacent space, usually the pleural cavity. The subxiphoid approach is erroneously referred to as a "window" because no connection is made to the adjacent space during the standard subxiphoid approach.
The thoracoscopic approach creates a true window but it is done under general anaesthesia with single-lung ventilation and through 2 or 3 intercostal ports. However, the role of the thoracoscopic approach is limited in patients with hemodynamically significant pericardial effusions due to the positioning of the patients in the lateral decubitus which makes emergency pericardiocentesis very difficult.
Recently , video-assisted thoracoscopic (VATS) pericardiotomy has gained popularity as a minimally invasive approach. VATS allows for visual evaluation of the pericardium and is used when the diagnosis of pericardial effusion has remained undiagnosed despite previous, less-invasive tests. It is also used to drain the excess fluid and prevent its reaccumulation.
Choosing the best surgical approach to drain the pericardial effusion is a matter of debate and it should be based upon the effectiveness of the approach in avoiding recurrence of the pericardial effusion and upon the morbidity and mortality associated with the procedure. Moreover, the relative simplicity of the procedure and its cost are other important aspects that should be considered when choosing the optimal surgical approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pericardiocentesis | Active comparator | Procedure: pericardial effusion drainagevitally unstable patients with tamponading pericardial effusion undergone percutaneous gradual drainage by a central venous catheter |
| subxiphoiodal drainage | Active comparator | Procedure: pericardial effusion drainagedrainage of the pericardial effusion through a subxiphoidal midline incision |
| thoracotomy | Active comparator | Procedure: pericardial effusion drainageencysted and undiagnosed pericardial effusion drainage through anterior thoracotomy performing a pericardiopleural window and take a pericardial biopsy |
| VATS drainage | Active comparator | Procedure: pericardial effusion drainageencysted and undiagnosed pericardial effusion drainage through VATS that permits performing a pericardiopleural window and take a pericardial biopsy with minimal incisions |
Who may qualify
- Ages
- 6 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Suspected malignant effusion . Systemic collagen diseases e.g; SLE , Rheumatoid Artheritis …… Suspected cases of tuberculosis .
Key exclusion criteria (1 listed)
- Cardiac tamponade as a complication of acute coronary syndromes Cardiac tamponade as a complication of aortic dissection . Pericardial effusion following penetrating and blunt chest trauma (heamopericardium).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pericardial effusion drainagetamponading pericardial effusion is a life threatenning condition , pericardiocentesis is performed for patients who are vitally unstable and with a massive amount of effusion to prevent cardiac tamponade, Surgical drainage of pericardial effusion was classically conducted by either open thoracotomy or subxiphoid pericardiectomy. Thoracoscopy has established itself as an alternative to open thoracotomy for the management of many pericardial, pleural and pulmonary disorders | Procedure or surgery | VATS drainage, pericardiocentesis, subxiphoiodal drainage, thoracotomy |
Primary outcome
recurrence
Time frame: 3 months
if there is a recurrence or not
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Background: PubMed 31918837Chiabrando JG, Bonaventura A, Vecchie A, Wohlford GF, Mauro AG, Jordan JH, Grizzard JD, Montecucco F, Berrocal DH, Brucato A, Imazio M, Abbate A. Management of Acute and Recurrent Pericarditis: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jan 7;75(1):76-92. doi: 10.1016/j.jacc.2019.11.021.
- Background: PubMed 23117314Saltzman AJ, Paz YE, Rene AG, Green P, Hassanin A, Argenziano MG, Rabbani L, Dangas G. Comparison of surgical pericardial drainage with percutaneous catheter drainage for pericardial effusion. J Invasive Cardiol. 2012 Nov;24(11):590-3.
- Background: PubMed 29025543Azarbal A, LeWinter MM. Pericardial Effusion. Cardiol Clin. 2017 Nov;35(4):515-524. doi: 10.1016/j.ccl.2017.07.005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pericardial effusion drainage in people with Pericardial Effusion, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05061914, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.