G Desolneux1, M Isambert1, S Mathoulin-Pelissier2, A Dupré3, M Rivoire4, V Cattena5, J Palussière5, D Dinart6, C Bellera7, S Evrard8. 1. Digestive Tumours Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France. 2. Clinical Research and Clinical Epidemiology Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France; Université de Bordeaux, 146 rue Léo Saignat, 33000, Bordeaux, France. 3. Department of Surgical Oncology, Centre Léon Bérard, Comprehensive Cancer Centre, 28 Promenade Léa et Napoléon Bullukian, 69008, Lyon, France. 4. Department of Surgical Oncology, Centre Léon Bérard, Comprehensive Cancer Centre, 28 Promenade Léa et Napoléon Bullukian, 69008, Lyon, France; Université de Lyon, 92 Rue Pasteur, 69007, Lyon, France. 5. Department of Interventional Radiology, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France. 6. Clinical Research and Clinical Epidemiology Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France. 7. Clinical Research and Clinical Epidemiology Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France; INSERM CIC-EC 14.01 (Clinical Epidemiology), Bordeaux, France. 8. Digestive Tumours Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France; Université de Bordeaux, 146 rue Léo Saignat, 33000, Bordeaux, France. Electronic address: s.evrard@bordeaux.unicancer.fr.
Abstract
BACKGROUND: Detecting more colorectal liver metastases (CRLMs) during surgery may help optimise strategy and improve outcomes. Our objective was to determine clinical utility (CU) of contrast-enhanced intra-operative ultrasound (CE-IOUS) using sulphur hexafluoride microbubbles during CRLM surgery. METHOD: A prospective phase II trial performed at two comprehensive cancer research centres. Patients operated for CRLMs were eligible and assessable if intra-operative ultrasound (IOUS) and CE-IOUS had been performed and pathological results were available and/or 3-month imaging. CU was defined as the justified change in planned surgical strategy or procedure using CE-IOUS. RESULTS: Out of the 68 patients enrolled, 54 were eligible and assessable. 43 patients underwent pre-operative chemotherapy. The median number of CRLMs was 2 (range, 1-11). Pre-operative staging was performed using MRI. IOUS allowed identification of 45 new CRLMs in 13 (24.7%) patients. Compared to IOUS, CE-IOUS allowed identification of 10 additional CRLMs in 9 (16.7%) patients. Surgery was altered and justified in 4 patients only, leading to a CU rate of 7.70% (95 CI, [3.2, 18.6]). No missing CRLMs were identified by CE-IOUS. CONCLUSIONS: Although the primary endpoint was not met for one protocol violation, secondary endpoints indicate that CE-IOUS has an intermediate added-value for surgeons treating CRLMs. TRIAL REGISTRATION: NCT01880554 (https://clinicaltrials.gov/).
BACKGROUND: Detecting more colorectal liver metastases (CRLMs) during surgery may help optimise strategy and improve outcomes. Our objective was to determine clinical utility (CU) of contrast-enhanced intra-operative ultrasound (CE-IOUS) using sulphur hexafluoride microbubbles during CRLM surgery. METHOD: A prospective phase II trial performed at two comprehensive cancer research centres. Patients operated for CRLMs were eligible and assessable if intra-operative ultrasound (IOUS) and CE-IOUS had been performed and pathological results were available and/or 3-month imaging. CU was defined as the justified change in planned surgical strategy or procedure using CE-IOUS. RESULTS: Out of the 68 patients enrolled, 54 were eligible and assessable. 43 patients underwent pre-operative chemotherapy. The median number of CRLMs was 2 (range, 1-11). Pre-operative staging was performed using MRI. IOUS allowed identification of 45 new CRLMs in 13 (24.7%) patients. Compared to IOUS, CE-IOUS allowed identification of 10 additional CRLMs in 9 (16.7%) patients. Surgery was altered and justified in 4 patients only, leading to a CU rate of 7.70% (95 CI, [3.2, 18.6]). No missing CRLMs were identified by CE-IOUS. CONCLUSIONS: Although the primary endpoint was not met for one protocol violation, secondary endpoints indicate that CE-IOUS has an intermediate added-value for surgeons treating CRLMs. TRIAL REGISTRATION: NCT01880554 (https://clinicaltrials.gov/).