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Surgical Options for Management of Pericardial Effusion

Primary Purpose

Pericardial Effusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pericardial effusion drainage
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pericardial Effusion

Eligibility Criteria

6 Months - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Suspected malignant effusion . Systemic collagen diseases e.g; SLE , Rheumatoid Artheritis …… Suspected cases of tuberculosis .

Exclusion Criteria:

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).

Sites / Locations

  • Sohag University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

pericardiocentesis

subxiphoiodal drainage

thoracotomy

VATS drainage

Arm Description

vitally unstable patients with tamponading pericardial effusion undergone percutaneous gradual drainage by a central venous catheter

drainage of the pericardial effusion through a subxiphoidal midline incision

encysted and undiagnosed pericardial effusion drainage through anterior thoracotomy performing a pericardiopleural window and take a pericardial biopsy

encysted and undiagnosed pericardial effusion drainage through VATS that permits performing a pericardiopleural window and take a pericardial biopsy with minimal incisions

Outcomes

Primary Outcome Measures

recurrence
if there is a recurrence or not

Secondary Outcome Measures

Full Information

First Posted
September 20, 2021
Last Updated
September 20, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05061914
Brief Title
Surgical Options for Management of Pericardial Effusion
Official Title
Surgical Options for Management of Pericardial Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
September 18, 2021 (Actual)
Study Completion Date
September 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericardial Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pericardiocentesis
Arm Type
Active Comparator
Arm Description
vitally unstable patients with tamponading pericardial effusion undergone percutaneous gradual drainage by a central venous catheter
Arm Title
subxiphoiodal drainage
Arm Type
Active Comparator
Arm Description
drainage of the pericardial effusion through a subxiphoidal midline incision
Arm Title
thoracotomy
Arm Type
Active Comparator
Arm Description
encysted and undiagnosed pericardial effusion drainage through anterior thoracotomy performing a pericardiopleural window and take a pericardial biopsy
Arm Title
VATS drainage
Arm Type
Active Comparator
Arm Description
encysted and undiagnosed pericardial effusion drainage through VATS that permits performing a pericardiopleural window and take a pericardial biopsy with minimal incisions
Intervention Type
Procedure
Intervention Name(s)
pericardial effusion drainage
Intervention Description
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
Primary Outcome Measure Information:
Title
recurrence
Description
if there is a recurrence or not
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected malignant effusion . Systemic collagen diseases e.g; SLE , Rheumatoid Artheritis …… Suspected cases of tuberculosis . Exclusion Criteria: 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).
Facility Information:
Facility Name
Sohag University
City
Sohag
ZIP/Postal Code
82514
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31918837
Citation
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.
Results Reference
background
PubMed Identifier
23117314
Citation
Saltzman 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.
Results Reference
background
PubMed Identifier
29025543
Citation
Azarbal A, LeWinter MM. Pericardial Effusion. Cardiol Clin. 2017 Nov;35(4):515-524. doi: 10.1016/j.ccl.2017.07.005.
Results Reference
background

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Surgical Options for Management of Pericardial Effusion

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