UNLABELLED: With the increasing possibilities for surgical treatment of colorectal liver metastases, careful selection of patients who may benefit from surgical treatment becomes critical. The addition of PET to (18)F-FDG may significantly improve conventional staging by CT. Up to now, definitive evidence that the addition of (18)F-FDG PET to conventional staging leads to superior clinical results and improved clinical management in these patients has been lacking. In this randomized controlled trial in patients with colorectal liver metastases, we investigated whether the addition of (18)F-FDG PET is beneficial and reduces the number of futile laparotomies. METHODS: A total of 150 patients with colorectal liver metastases selected for surgical treatment by imaging with CT were randomly assigned to CT only (n = 75) or CT plus (18)F-FDG PET (n = 75). Patients were followed up for at least 3 y. The primary outcome measure was futile laparotomy, defined as any laparotomy that did not result in complete tumor treatment, that revealed benign disease, or that did not result in a disease-free survival period longer than 6 mo. RESULTS: Patient and tumor characteristics were similar for both groups. The number of futile laparotomies was 34 (45%) in the control arm without (18)F-FDG PET and 21 (28%) in the experimental arm with (18)F-FDG PET; the relative risk reduction was 38% (95% confidence interval, 4%-60%, P = 0.042). CONCLUSION: The number of futile laparotomies was reduced from 45% to 28%; thus, the addition of (18)F-FDG PET to the work-up for surgical resection of colorectal liver metastases prevents unnecessary surgery in 1 of 6 patients.
RCT Entities:
UNLABELLED: With the increasing possibilities for surgical treatment of colorectal liver metastases, careful selection of patients who may benefit from surgical treatment becomes critical. The addition of PET to (18)F-FDG may significantly improve conventional staging by CT. Up to now, definitive evidence that the addition of (18)F-FDG PET to conventional staging leads to superior clinical results and improved clinical management in these patients has been lacking. In this randomized controlled trial in patients with colorectal liver metastases, we investigated whether the addition of (18)F-FDG PET is beneficial and reduces the number of futile laparotomies. METHODS: A total of 150 patients with colorectal liver metastases selected for surgical treatment by imaging with CT were randomly assigned to CT only (n = 75) or CT plus (18)F-FDG PET (n = 75). Patients were followed up for at least 3 y. The primary outcome measure was futile laparotomy, defined as any laparotomy that did not result in complete tumor treatment, that revealed benign disease, or that did not result in a disease-free survival period longer than 6 mo. RESULTS:Patient and tumor characteristics were similar for both groups. The number of futile laparotomies was 34 (45%) in the control arm without (18)F-FDG PET and 21 (28%) in the experimental arm with (18)F-FDG PET; the relative risk reduction was 38% (95% confidence interval, 4%-60%, P = 0.042). CONCLUSION: The number of futile laparotomies was reduced from 45% to 28%; thus, the addition of (18)F-FDG PET to the work-up for surgical resection of colorectal liver metastases prevents unnecessary surgery in 1 of 6 patients.
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