Study of the Quality of Lung Resection

Bronchial Cancer Clinical Trial

— ResPul  

Official title:

Measurement of the Quality: Application to Lung Resection for Cancer Using a National PMSI Database

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02877043
• Other study ID #: PAGES AOI 2015
• Status: Active, not recruiting
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 19, 2016
• Start date: December 2015

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

In 2009, centres that carried out lung resection for cancer were required to obtain authorization following the first cancer plan. One of the criteria to obtain authorization was the volume of activity: the centre had to carry out at least 30 lung resections per year for cancer. Five years later, it would be useful to know the impact of this new organization of oncology on the quality of care. To answer this question, the PMSI database is an ideal source of an indicator of quality: in-hospital mortality. This observational cohort study will be conducted using the national PMSI database with data covering the period from 1st January 2005 to 31st December 2013. It will be limited to hospitalization for lung resection. The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period 2008-2010 includes the implementation of authorizations for cancer surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72000
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Any patients who underwent lung resection for bronchial cancer will be included in this study. The PMSI (Programme de Médicalisation des Systèmes d'Information) database will be searched for all patients with:

• A principal diagnosis of ICD10 (international classification of diseases) codes for bronchial cancer

• And CCAM (Classification Commune des Actes médicaux ) procedure codes for lung resection (segmentectomy, lobectomy, pneumonectomy).

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bronchial Cancer
• Carcinoma, Bronchogenic

Intervention

Procedure:
• resection pulmonaire

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of deaths during hospitalization	number of death during hospitalization for pulmonary resection from 2005 to 2013	9 years	No