Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension (ETHAPE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Treatments: Other: Angiography and Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT00657722

K060205

Details and patient eligibility

About

In order to improve effectiveness of the surgical operation thanks to a reduction in the rate of failure, this study will allow us to identify predictive angiographic and CT finding of surgical failure, starting from standardized reading grids, in order to have a better selection of the operable patients.

Full description

Chronic thromboembolic pulmonary hypertension(CTEPH) is caused by obstruction of the large pulmonary arteries by acute and recurrent pulmonary emboli, and organization of these blood clots. ANTOINE BECLERE respiratory unit, in partnership with the MARIE LANNELONGUE hospital thoracic and vascular surgery departments was designated recently as reference national centre for pulmonary hypertension and represents the only French structure for evaluation of CTEPH with 150 patients addressed each year.If the disease is proximately located, CTEPH can be cured surgically through a complex surgical procedure performed under Hypothermia and total circulatory arrest. In spite of multidisciplinary meeting deciding the operability of each case the rate of failure is approximately of 15% (9% of operative mortality rate and 6% of technical failure).

The aim of this study is to identify predictive angiographic and CT findings of success, by allowing a better selection of operable patients.

It would be possible to improve the effectiveness of the surgical treatment and reduce the rate failure from 15% to 7 % or even 5 %.

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients addressed to the reference centre of pulmonary hypertension for a suspected CPC-PE
• Achieving an assessment prior to the operation, including:1) Right cardiac catheterization confirming HTP with a mean pulmonary arterial pressure> 25 mm Hg at rest; 2) Echography and Doppler of the lower limbs in search of phlebitis sequela; 3) Pulmonary scintigraphy with 6 views in ventilation and perfusion; 4) Digital pulmonary angiography; 5) A 64 detector pulmonary computed tomography; 6) Having read the briefing note and given their agreement.

Exclusion criteria

• Refusal examinations .
• Patient for which one method is contraindicated
• Patient considered not operable by the staff
• Life expectancy of less than 3 months
• Geographical distance for the clinical follow-up at 3 months
• Renal insufficiency (creatinine clearance <30 mL / min)
• Proven allergy to iodinated contrast agents
• Pregnant woman.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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249 participants in 1 patient group

1

Experimental group

Description:

Angiography and Computed Tomography

Treatment:

Other: Angiography and Computed Tomography