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Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage

ABSTRACT: Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC. The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer. The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or hand-sewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision. A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited. In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes.

DISEASE(S): Colorectal Cancer,Anastomotic Leak

PROVIDER: 2399221 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Alterations in glycosylation are seen in many types of cancer, including colorectal cancer (CRC). CRC is known to display glycosylation alterations. Glycans, the sugar moieties of glycoconjugates, are involved in many important functions relevant to cancer, such as cell signaling and adhesion, and may can be of value as biomarkers. In this study, we have used mass spectrometry to analyze the N-glycan profiles of 35 CRC tissue samples from patients with tumors in the right or left colon and 10 healthy tissue samples from non-CRC patients who underwent operations for other reasons. The tumor samples were divided into groups depending on tumor location (right or left colon) and stage (II or III), while the healthy samples were divided into right or left side of the colon. The levels of neutral and acidic N-glycan compositions and glycan classes were analyzed in a total of ten different groups. Surprisingly, there were no significant differences in glycan levels when all right- and left-sided CRC samples were compared, and few differences (such as in the abundance of the neutral N-glycan H3N5) were seen when the samples were divided according to both location and stage. Multiple significant differences were found in the levels of glycans and glycan classes when stage II and III samples were compared, and these glycans could be of value as candidates for new markers of cancer progression. In order to validate our findings, we analyzed healthy tissue samples from the right and left colon and found no significant differences in the levels of any of the glycans analyzed, confirming that our findings when comparing CRC samples from the right and left colon are not due to normal variations in the levels of glycans between the healthy right and left colon. Additionally, the levels of the acidic glycans H4N3F1P1, H5N4F1P1, and S1H5N4F1 were found to change in a cancer-specific but colon location-nonspecific manner, indicating that CRC affects glycan levels in similar ways, regardless of tumor location.

Project description:Interventions: Elective or emergent colonic resection, defined using the procedural ICD-10 codes: 32000-00 Limited excision of large intestine with formation of stoma 32000-01 Right hemicolectomy with formation of stoma 32000-02 Laparoscopic limited excision of large intestine with formation of stoma 32000-03 Laparoscopic right hemicolectomy with formation of stoma 32003-00 Limited excision of large intestine with anastomosis 32003-01 Right hemicolectomy with anastomosis 32003-02 Laparoscopic limited excision of large intestine with anastomosis 32003-03 Laparoscopic right hemicolectomy with anastomosis 32004-00 Subtotal colectomy with formation of stoma 32004-01 Extended right hemicolectomy with formation of stoma 32004-02 Laparoscopic subtotal colectomy with formation of stoma 32004-03 Laparoscopic extended right hemicolectomy with formation of stoma 32005-00 Subtotal colectomy with anastomosis 32005-01 Extended right hemicolectomy with anastomosis 32005-02 Laparoscopic subtotal colectomy with anastomosis 32005-03 Laparoscopic extended right hemicolectomy with anastomosis 32006-00 Left hemicolectomy with anastomosis 32006-01 Left hemicolectomy with formation of stoma 32006-02 Laparoscopic left hemicolectomy with anastomosis 32006-03 Laparoscopic left hemicolectomy with formation of stoma 32009-00 Total colectomy with ileostomy 32009-01 Laparoscopic total colectomy with ileostomy 32012-00 Total colectomy with ileorectal anastomosis 32012-01 Laparoscopic total colectomy with ileorectal anastomosis The procedures were performed at the Austin Hospital, a tertiary hospital with colorectal expertise, over the period of January 2013 and June 2018. Patients were followed-up for 30 days following discharge from the index admission. If no subsequent readmissions occurred within this period, follow-up ceased. If a patient was readmitted within the 30-day period, then the readmission was included, and followi Primary outcome(s): Costs of complications (as a composite outcome) following Colon resections. Costs of complications defined as cost of patients with complications less the cost of patients without complications (ie by comparison of patients with and without complications). All costs related to the index admission for colon resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of costs will be calculated using an activity-based costing methodology. Only in-hospital costs are considered, with both direct and indirect costs assessed to produce a total cost for each patient. Costs for each patient will be obtained from the Austin Health Department of Finance, which maintain an itemised prospective database of all hospital expenses related to each patient.[Costs will be calculated from day of surgery to hospital discharge. Readmissions are considered within 30 days of discharge from the index admission.] Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Retrospective

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Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage

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