NCT05061914

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

5.6 years

First QC Date

September 20, 2021

Last Update Submit

September 20, 2021

Conditions

Pericardial Effusion

Outcome Measures

Primary Outcomes (1)

  • recurrence

    if there is a recurrence or not

    3 months

Study Arms (4)

pericardiocentesis

ACTIVE COMPARATOR

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

Procedure: pericardial effusion drainage

subxiphoiodal drainage

ACTIVE COMPARATOR

drainage of the pericardial effusion through a subxiphoidal midline incision

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

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

Procedure: pericardial effusion drainage

Interventions

pericardial effusion drainagePROCEDURE

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

VATS drainagepericardiocentesissubxiphoiodal drainagethoracotomy

Eligibility Criteria

Age6 Months - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82514, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 31918837BACKGROUND

  • 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.

    PMID: 23117314BACKGROUND

  • Azarbal A, LeWinter MM. Pericardial Effusion. Cardiol Clin. 2017 Nov;35(4):515-524. doi: 10.1016/j.ccl.2017.07.005.

    PMID: 29025543BACKGROUND

MeSH Terms

Conditions

Pericardial Effusion

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at cardiothoracic surgery department

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 30, 2021

Study Start

March 1, 2016

Primary Completion

September 18, 2021

Study Completion

September 18, 2021

Last Updated

September 30, 2021

Record last verified: 2021-09

Locations

EG(1)