Multicentre phase II trial of near-infrared imaging in elective colorectal surgery

F Ris, E Liot, N C Buchs, R Kraus, G Ismael, V Belfontali, J Douissard, C Cunningham, I Lindsey, R Guy, O Jones, B George, P Morel, N J Mortensen, R Hompes, R A Cahill, Near-Infrared Anastomotic Perfusion Assessment Network VOIR, F Ris, E Liot, N C Buchs, R Kraus, G Ismael, V Belfontali, J Douissard, C Cunningham, I Lindsey, R Guy, O Jones, B George, P Morel, N J Mortensen, R Hompes, R A Cahill, Near-Infrared Anastomotic Perfusion Assessment Network VOIR

Abstract

Background: Decreasing anastomotic leak rates remain a major goal in colorectal surgery. Assessing intraoperative perfusion by indocyanine green (ICG) with near-infrared (NIR) visualization may assist in selection of intestinal transection level and subsequent anastomotic vascular sufficiency. This study examined the use of NIR-ICG imaging in colorectal surgery.

Methods: This was a prospective phase II study (NCT02459405) of non-selected patients undergoing any elective colorectal operation with anastomosis over a 3-year interval in three tertiary hospitals. A standard protocol was followed to assess NIR-ICG perfusion before and after anastomosis construction in comparison with standard operator visual assessment alone.

Results: Five hundred and four patients (median age 64 years, 279 men) having surgery for neoplastic (330) and benign (174) pathology were studied. Some 425 operations (85·3 per cent) were started laparoscopically, with a conversion rate of 5·9 per cent. In all, 220 patients (43·7 per cent) underwent high anterior resection or reversal of Hartmann's operation, and 90 (17·9 per cent) low anterior resection. ICG angiography was achieved in every patient, with a median interval of 29 s to visualization of the signal after injection. NIR-ICG assessment resulted in a change in the site of bowel division in 29 patients (5·8 per cent) with no subsequent leaks in these patients. Leak rates were 2·4 per cent overall (12 of 504), 2·6 per cent for colorectal anastomoses and 3 per cent for low anterior resection. When NIR-ICG imaging was used, the anastomotic leak rates were lower than those in the participating centres from over 1000 similar operations performed with identical technique but without NIR-ICG technology.

Conclusion: Routine NIR-ICG assessment in patients undergoing elective colorectal surgery is feasible. NIR-ICG use may change intraoperative decisions, which may lead to a reduction in anastomotic leak rates.

© 2018 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

Figures

Figure 1
Figure 1
Near‐infrared (NIR) assessment of level of transection. Images of a planned transection before indocyanine green (ICG) injection (arrow) and b visible transection area after ICG injection (arrow) are shown in normal view, NIR view and enhanced reality view. There is no change in transection area if the perfusion signal reaches the planned area for transection
Figure 2
Figure 2
Near‐infrared (NIR) perfusion assessment after a side‐to‐end colorectal anastomosis had been constructed. Intraoperative images of the anastomosis a before and b after indocyanine green (ICG) injection are shown in normal view, NIR view and enhanced reality view. After ICG injection, there was a good signal on the rectal stump and colon
Figure 3
Figure 3
Near‐infrared (NIR) perfusion assessment with change of plan owing to a lack of perfusion at the level of the section originally planned. Intraoperative images are shown in normal view, NIR view and enhanced reality view. a Image before indocyanine green (ICG) injection showing the planned area for proximal transection (yellow arrow) in a segment of descending colon after its mobilization (including high vascular ligation) and mesocolic preparation. b After ICG injection, a clear demarcation line appeared (white arrow) that was 4 cm more proximal (vertical yellow arrow on the initial transection area) and led to more proximal transection (horizontal arrow shows distance that has been assessed as well perfused) being undertaken. c A second injection of ICG in the same patient showed satisfactory perfusion of the constructed colorectal anastomosis in situ

References

    1. Vallance A, Wexner S, Berho M, Cahill R, Coleman M, Haboubi N et al A collaborative review of the current concepts and challenges of anastomotic leaks in colorectal surgery. Colorectal Dis 2017; 19: O1–O12.
    1. Pommergaard HC, Gessler B, Burcharth J, Angenete E, Haglind E, Rosenberg J. Preoperative risk factors for anastomotic leakage after resection for colorectal cancer: a systematic review and meta‐analysis. Colorectal Dis 2014; 16: 662–671.
    1. Scarborough JE, Mantyh CR, Sun Z, Migaly J. Combined mechanical and oral antibiotic bowel preparation reduces incisional surgical site infection and anastomotic leak rates after elective colorectal resection: an analysis of colectomy‐targeted ACS NSQIP. Ann Surg 2015; 262: 331–337.
    1. Sammour T, Hayes IP, Jones IT, Steel MC, Faragher I, Gibbs P. Impact of anastomotic leak on recurrence and survival after colorectal cancer surgery: a BioGrid Australia analysis. ANZ J Surg 2018; 88: E6–E10.
    1. 2015 European Society of Coloproctology Collaborating Group . The relationship between method of anastomosis and anastomotic failure after right hemicolectomy and ileo‐caecal resection: an international snapshot audit. Colorectal Dis 2017; 19: e296–e311.
    1. Jessen M, Nerstrøm M, Wilbek TE, Roepstorff S, Rasmussen MS, Krarup PM. Risk factors for clinical anastomotic leakage after right hemicolectomy. Int J Colorectal Dis 2016; 31: 1619–1624.
    1. McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg 2015; 102: 462–479.
    1. Ris F, Yeung T, Hompes R, Mortensen NJ. Enhanced reality and intraoperative imaging in colorectal surgery. Clin Colon Rectal Surg 2015; 28: 158–164.
    1. Chadi SA, Fingerhut A, Berho M, DeMeester SR, Fleshman JW, Hyman NH et al Emerging trends in the etiology, prevention, and treatment of gastrointestinal anastomotic leakage. J Gastrointest Surg 2016; 20: 2035–2051.
    1. Sherwinter DA. Transanal near‐infrared imaging of colorectal anastomotic perfusion. Surg Laparosc Endosc Percutan Tech 2012; 22: 433–436.
    1. Sherwinter DA, Gallagher J, Donkar T. Intra‐operative transanal near infrared imaging of colorectal anastomotic perfusion: a feasibility study. Colorectal Dis 2013; 15: 91–96.
    1. Ris F, Hompes R, Cunningham C, Lindsey I, Guy R, Jones O et al Near‐infrared (NIR) perfusion angiography in minimally invasive colorectal surgery. Surg Endosc 2014; 28: 2221–2226.
    1. Jafari MD, Wexner SD, Martz JE, McLemore EC, Margolin DA, Sherwinter DA et al Perfusion assessment in laparoscopic left‐sided/anterior resection (PILLAR II): a multi‐institutional study. J Am Coll Surg 2015; 220: 82–92.e1.
    1. Boni L, David G, Dionigi G, Rausei S, Cassinotti E, Fingerhut A. Indocyanine green‐enhanced fluorescence to assess bowel perfusion during laparoscopic colorectal resection. Surg Endosc 2016; 30: 2736–2742.
    1. Boni L, Fingerhut A, Marzorati A, Rausei S, Dionigi G, Cassinotti E. Indocyanine green fluorescence angiography during laparoscopic low anterior resection: results of a case‐matched study. Surg Endosc 2017; 31: 1836–1840.
    1. Jafari MD, Lee KH, Halabi WJ, Mills SD, Carmichael JC, Stamos MJ et al The use of indocyanine green fluorescence to assess anastomotic perfusion during robotic assisted laparoscopic rectal surgery. Surg Endosc 2013; 27: 3003–3008.
    1. Cahill RA, Ris F, Mortensen NJ. Near‐infrared laparoscopy for real‐time intra‐operative arterial and lymphatic perfusion imaging. Colorectal Dis 2011; 13(Suppl 7): 12–17.
    1. Ris F, Hompes R, Lindsey I, Cunningham C, Mortensen NJ, Cahill RA. Near infra‐red laparoscopic assessment of the adequacy of blood perfusion of intestinal anastomosis – a video vignette. Colorectal Dis 2014; 16: 646–647.
    1. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD et al The Clavien–Dindo classification of surgical complications: five‐year experience. Ann Surg 2009; 250: 187–196.
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205–213.
    1. Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A et al Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery 2010; 147: 339–351.
    1. Buchs NC, Gervaz P, Secic M, Bucher P, Mugnier‐Konrad B, Morel P. Incidence, consequences, and risk factors for anastomotic dehiscence after colorectal surgery: a prospective monocentric study. Int J Colorectal Dis 2008; 23: 265–270.
    1. ISRCTN Registry . IntAct: Intraoperative Fluorescence Angiography to Prevent Anastomotic Leak in Rectal Cancer Surgery [accessed 3 September 2017].
    1. Shogan BD, Belogortseva N, Luong PM, Zaborin A, Lax S, Bethel C et al Collagen degradation and MMP9 activation by Enterococcus faecalis contribute to intestinal anastomotic leak. Sci Transl Med 2015; 7: 286ra68.
    1. Ashraf SQ, Burns EM, Jani A, Altman S, Young JD, Cunningham C et al The economic impact of anastomotic leakage after anterior resections in English NHS hospitals: are we adequately remunerating them? Colorectal Dis 2013; 15: e190–e198.
    1. Hammond J, Lim S, Wan Y, Gao X, Patkar A. The burden of gastrointestinal anastomotic leaks: an evaluation of clinical and economic outcomes. J Gastrointest Surg 2014; 18: 1176–1185.
    1. Diana M, Noll E, Diemunsch P, Dallemagne B, Benahmed MA, Agnus V et al Enhanced‐reality video fluorescence: a real‐time assessment of intestinal viability. Ann Surg 2014; 259: 700–707.
    1. Diana M, Agnus V, Halvax P, Liu YY, Dallemagne B, Schlagowski AI et al Intraoperative fluorescence‐based enhanced reality laparoscopic real‐time imaging to assess bowel perfusion at the anastomotic site in an experimental model. Br J Surg 2015; 102: e169–e176.
    1. Daly HC, Sampedro G, Bon C, Wu D, Ismail G, Cahill RA et al BF2‐azadipyrromethene NIR‐emissive fluorophores with research and clinical potential. Eur J Med Chem 2017; 135: 392–400.
    1. Nguyen QT, Tsien RY. Fluorescence‐guided surgery with live molecular navigation‐‐a new cutting edge. Nat Rev Cancer 2013; 13: 653–662.

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