Clinical trial NCT02459405: Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging
Official title: Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anastomotic Leak
Keywords: Colorectal surgery
Near infrared
Indocyanine green
anastomotic leak
Prevention of leak
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: University College Dublin
First posted: 2015-06-02
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread means of assessing the viability of a laparoscopic anastomosis. The investigators described recently the feasibility of microvascularisation assessment with near-infra red technology (NIR).

The aim of this study is to look at the implementation of this technique in a wider prospective series of patients undergoing colorectal resection.

Detailed description: Multicentric prospective study of 260 consecutive patients undergoing colonic resection and being assessed during the course of surgery for microvascularisation.

After vessel division and after colorectal anastomosis, indocyanine green (2.5mg/ml) is injected intravenously and anastomotic microvascularisation assessed with the PinPoint NIR system (Novadaq, Vancouver, Canada).

Study primary endpoint is the anastomotic leak rate Secondary endpoint are peroperative and post-operative complications according to the Clavien Dindo scale, time of the procedure and time to record a signal as well as any change of the procedure.

This study will be performed on 3 different sites Geneva, Oxford and Dublin University Hospitals

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Participant willing and able to comply with the study procedures.
* Diagnosed with required colon or rectal neoplasia requiring surgical excision by either laparoscopic or open surgery.
* A negative pregnancy test for women of childbearing potential prior to surgery
* Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
* Allergy to Indocyanine green.
* Participant who is undergoing purely palliative surgery or who is terminally ill
* Subject has other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: first 30 days
Secondary outcomes:
measure: Time to perform the near infrared procedure
timeFrame: during surgery
measure: Time to get a near infrared signal
timeFrame: during surgery
measure: complication rate
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Alteration of the course of surgery due to insufficient vascularisation
timeFrame: during surgery
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Dublin University College, department of colorectal surgery
city: Milan
country: Italy
facility: Humanitas Universtity Hospitals
state: Rozzano (Milano)
city: Geneva
country: Switzerland
facility: Geneva University Hospitals, Service of Visceral Surgery
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals, Department of colorectal Surgery
state: Oxfordshire
Study officials:
affiliation: University Hospital, Geneva
name: Frederic Ris, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ris F, Hompes R, Cunningham C, Lindsey I, Guy R, Jones O, George B, Cahill RA, Mortensen NJ. Near-infrared (NIR) perfusion angiography in minimally invasive colorectal surgery. Surg Endosc. 2014 Jul;28(7):2221-6. doi: 10.1007/s00464-014-3432-y. Epub 2014 Feb 25.
citation: Cahill RA, Ris F, Mortensen NJ. Near-infrared laparoscopy for real-time intra-operative arterial and lymphatic perfusion imaging. Colorectal Dis. 2011 Nov;13 Suppl 7:12-7. doi: 10.1111/j.1463-1318.2011.02772.x.
citation: Ris F, Liot E, Buchs NC, Kraus R, Ismael G, Belfontali V, Douissard J, Cunningham C, Lindsey I, Guy R, Jones O, George B, Morel P, Mortensen NJ, Hompes R, Cahill RA; Near-Infrared Anastomotic Perfusion Assessment Network VOIR. Multicentre phase II trial of near-infrared imaging in elective colorectal surgery. Br J Surg. 2018 Sep;105(10):1359-1367. doi: 10.1002/bjs.10844. Epub 2018 Apr 16.