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

Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Other: Angiography and Computed Tomography

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 %.

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92141
    • Hôpital Antoine Béclère
  • Le Plessis Robinson, France, 92350
    • Hospital Marie Lannelongue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Angiography and Computed Tomography	Other: Angiography and Computed Tomography; Preoperative angiography and Computed Tomography; Other Names: standardized reading grids of APN and ASMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
surgical effectiveness evaluated by the death or failure rate.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
surgical effectiveness evaluated by the death or failure rate.	3 months
Check that none of the patients considered unresectable on data from staff was declared operable with the criteria predictive success of imaging examinations.	before surgery
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.	before surgery
Determine the incidence of adverse events associated with each of these two exams or their combination.	3 and 6 months after surgery
Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT	Before surgery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Mathieu LIBERATORE, MD, Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère; Study Director: Dominique MUSSET, MD, PhD, Assistance Publique - Hopitaux de Paris, Hôpital Antoine Beclere; Study Director: Gerald SIMONNEAU, MD, PhD, Assistance Publique - Hopitaux de Paris, Hôpital Antoine Beclere

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: April 11, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Estimate): April 11, 2013
• Last Update Submitted That Met QC Criteria: April 10, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Computed tomography; Pulmonary hypertension; Chronic thromboembolic pulmonary hypertension; Operability; Thromboendarteriectomy; Operative mortality rate; Technical failure; Pulmonary angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: K060205