Clinical trial NCT00657722: Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension
Official title: Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Pulmonary hypertension
Chronic thromboembolic pulmonary hypertension
Operability
Thromboendarteriectomy
Operative mortality rate
Technical failure
Pulmonary angiography
Computed tomography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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 %.

Eligibility criteria: 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.

Primary outcomes:
measure: surgical effectiveness evaluated by the death or failure rate.
timeFrame: 6 months
Secondary outcomes:
measure: surgical effectiveness evaluated by the death or failure rate.
timeFrame: 3 months
measure: Check that none of the patients considered unresectable on data from staff was declared operable with the criteria predictive success of imaging examinations.
timeFrame: before surgery
measure: Determine the interest of pulmonary angiography in the operability decision compared first to Multi detector AngioCT alone with standardized analyze and then with the both exams.
timeFrame: before surgery
measure: Determine the incidence of adverse events associated with each of these two exams or their combination.
timeFrame: 3 and 6 months after surgery
measure: Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT
timeFrame: Before surgery
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital Antoine Beclere
city: Le Plessis Robinson
country: France
facility: Hospital Marie Lannelongue
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
name: Mathieu LIBERATORE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
name: Dominique MUSSET, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
name: Gerald SIMONNEAU, MD, PhD
role: STUDY_DIRECTOR
References: