CLIMB 1409

A Prospective Colorectal Liver Metastasis Database with an Integrated Quality Assurance Program

Transcript

1. CLIMB 1409 – A Prospective Colorectal Liver Metastasis Database with an Integrated Quality Assurance Program A Collaboration Project with the & the European Organization for the Research and Treatment of Cancer
2. Why we need CLIMB… To strengthen Quality Assurance initiatives for Surgery To foster collaboration between ESSO and EORTC An opportunity to do a prospective study for liver metastasis surgery To answer important questions: Is surgery truly beneficial for initially unresectable CRLM patients? How can we improve surgical strategies? What quality indicators can we use to improve patient care? 2
3. 1409: CLIMB Study Design • Prospective observational cohort study with optional translational research • Participating sites (ESSO and EORTC Network) • France • United Kingdom • Netherlands • Italy • Switzerland • Denmark • Norway • Sweden 3
4. 1409: CLIMB Organization • Study Coordinator • Serge Evrard • Head of the Digestive Tumors Unit • Institut Bergonié • ESSO Clinical Research Director • Co-coordinator • Graeme Poston • Hepatobiliary Center • Aintree University Hospital • ESSO President • Clinical Research Fellow • Carmela Isabel Caballero, MD (EORTC) 4
5. 1409: CLIMB Patient Population • All patients with colorectal adenocarcinoma with unresectable or initially unresectable liver metastasis who are potential candidates for a surgical procedure • Patient must be discussed within a multidisciplinary tumor board before surgery. 5
6. 1409: CLIMB Primary Objectives • Evaluate the complications from different surgical strategies for initially unresectable liver metastasis from colorectal cancer. • Develop thresholds for quality parameters for different surgical strategies for initially unresectable liver metastases from colorectal cancer. 6
7. 1409: CLIMB Secondary Objectives • Determine the long-term outcomes of patients with CRLM who undergo different treatment strategies • Determine the short-term impact of participating in a database in terms of improved complication rates among participating institutions 7
8. 1409: CLIMB Database Development 8 Start up phase • Development of the protocol and the database • Selection and activation of the participating institutions • Development of the infrastructure 1st analysis • Review of the data, benchmarking for Quality parameters • Identification of the source of errors • Selection of targets for improvement • Development of an action plan to improve the selected targets • Analyses of short-term outcome (DFS, PFS) Implementation phase • Implementation of processes to improve predefined targets 2nd analysis • Review of the data, benchmarking • Analysis of the impact of implemented processes on the targets • Analyses of outcome (DFS, PFS, OS)