ClinicalTrials.gg
Active, not recruitingNCT06972836Updated May 15, 2025

Safety and Efficacy of Awake Uniportal Video Assisted Thoracoscopic Modified Pericardial Window in Recurrent Pericardial Effusion at Mid Term Result

An interventional study of modified pericardial window and traditional pericardial window in Awake Thoracoscope, Pericardial Effusion and Pericadiopleural Window, sponsored by Zagazig University. Active, not recruiting at 2 sites in Egypt. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Zagazig University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as active, not recruiting.
  • Registered 6 months after the study started (first participant enrolled Oct 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study summary

this study compare two surgical techniues at the same time two methods of anathesia with assisstance of thoracoscope for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months

Read the detailed description

this study compare two thoracoscopic techniues awake modified pericardial window and pericardial window under general anasethia for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months

02

Conditions studied

  • Awake Thoracoscope
  • Pericardial Effusion
  • Pericadiopleural Window

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Keywords

  • pericardial effusion
  • pericardiopleural window
03

In context

Pericardial Effusion

29 studies on the registry are indexed under Pericardial Effusion; 5 are open to participants now.

This study's enrollment of 36 is below the median of 78 across 24 interventional studies indexed under Pericardial Effusion.

Browse Pericardial Effusion studies →

Lead sponsor

Zagazig University is the lead sponsor of 457 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who presented with recurrent massive pericardial effusion based on clinical, radiological evidence by Echo and C.T. chest

Exclusion criteria

Exclusion Criteria:

  • hemodynamically unstable patients
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Awake modified pericardial window

    H) shaped lines done by diathemy hoke above phrenic nerve then the upper and lower pericardial flabs reflelected outward in upper and lower directions respectively then 3 large clips applied on each angle of the reflected pericardial anlgles then heavy non absorbable suture is taken from the centre of the free reflected edge to adjacent upper and lower pericardium

    Procedure: modified pericardial window

  • Active comparator
    General traditional pericardial window

    A portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook

    Procedure: traditional pericardial window

Interventions

  • Proceduremodified pericardial window

    (H) shaped lines done by diathemy hoke above phrenic nerve then the upper and lower pericardial flabs reflelected outward in upper and lower directions respectively then 3 large clips applied on each angle of the reflected pericardial anlgles then heavy non absorbable suture is taken from the centre of the free reflected edge to adjacent upper and lower pericardium

  • Proceduretraditional pericardial window

    A portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook

06

What researchers measure

Primary outcomes

  1. recurrence of pericardial effusion

    clinical (Beck's triad:Hypotension with a narrowed pulse pressure,jugular venous distension,distant heart sounds )and Echo findings suggestive of recurrence of pericardial effusion

    Time frame: follow up each month at out patient clinic for 6 months from the date of surgery

  2. Awake anasethia

    the patient is sedated -cooperative- hemodynamically stable by transthoracic spinal anasthsia at Cervical 5

    Time frame: from the start till the end of the procedure about 45 min

07

Study locations

2 sites
  • Amr El Sayed Tawfek
    Zagazig, Sharqia Province 44519, Egypt
  • cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt
    Zagazig, Sharqia Province 44519, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06972836
Lead sponsor
Zagazig University
Responsible party
Amr Elsayed Tawfek Ibrahim (assisstant professor, Zagazig University) — Principal investigator
First posted
May 15, 2025
Start date
Oct 20, 2024
Primary completion
Aug 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
May 15, 2025

Study contacts

Amr Tawfek, as prof
principal investigator · cardiothoracic surgery department-faculty of medecine-zagazig univeristy-Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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