Anastomotic LeakPhase 2NCT02459405
Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging
A Phase 2 study testing NIR anastomotic perfusion assessment and Near infrared camera in people with Anastomotic Leak, run by University Hospital, Geneva at 4 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- NIR anastomotic perfusion assessment and Near infrared camera
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Mar 2013to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Ireland1 site
Dublin University College, department of colorectal surgery
Dublin, 4
Switzerland1 site
Geneva University Hospitals, Service of Visceral Surgery
Geneva, 1224
United Kingdom1 site
Oxford University Hospitals, Department of colorectal Surgery
Oxford, Oxfordshire, OX3
About this study
Official title: Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study
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.
Read the 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
- Conditions
- Anastomotic Leak
- Being tested
- NIR anastomotic perfusion assessment, Near infrared camera
- Keywords
- Colorectal surgery, Near infrared, Indocyanine green, anastomotic leak, Prevention of leak
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIR anastomotic perfusion assessmentProcedure or surgery
Also called Indocyanine assessment of anastomotic microvascularisation
Patient will have their anastomosis assessed by near infrared technology after indocyanine green has been injected i.v. The procedure will be repeated twice, once before the anastomosis and the second time after the anastomosis has been performed.
Near infrared cameraDevice
Also called Pinpoint evaluation
Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
| Study group | Role | What they receive |
|---|---|---|
| NIR anastomotic perfusion assessment | Experimental | Patient will have their anastomosis assessed after they receive 7.5 to 9 mg of Indocyanine green intravenously (at a concentration of 2.5mg/ml).
The microvascularisation assessment will be performed using a near infrared device(Pinpoint device), allowing to increase reality.
This procedure will be repeated twice during the surgery, the first time before and the second time after the anastomosis has been done. Receives: Procedure: NIR anastomotic perfusion assessment; Device: Near infrared camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak rate
anastomotic leak rate at 30 post operative days
Measured: first 30 days
Secondary outcomes (5)
Time to perform the near infrared procedure
measured added time to the procedure
Measured: during surgery
Time to get a near infrared signal
Time to see a signal during surgery
Measured: during surgery
complication rate
according to Clavien Dindo classification
Measured: 30 days
Mortality
30 days mortality
Measured: 30 days
Alteration of the course of surgery due to insufficient vascularisation
If the vascularisation is insufficient during the surgery, the investigators can change the course of the surgery he is performing. For example, it could lead to a second resection to obtain well vascularized tissue for the anastomosis. Any alteration of the regular course of surgery for the safety of the patient is reported. The number of patient requiring an alteration of the course of surgery will be recorded.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, University College Dublin
- Responsible party
- Principal investigator, Ris Frederic, University Hospital, Geneva
- Investigators
- Frederic Ris, MD, Prof, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459405
- Sponsor's protocol ID
- 10/H0724/13
- Status last verified
- May 2021
- First submitted
- 4 Apr 2015
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24566744Cahill 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.
PubMed 22098511Clough EJ, Nightingale K, Smith S, Burke JR. Investigating the Benefit of Fluorescence in Acute Mesenteric Ischaemia: A Systematic Review and Narrative Synthesis. ANZ J Surg. 2026 Apr;96(4):733-741. doi: 10.1111/ans.70433. Epub 2026 Jan 1.
PubMed 41479254Ris 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.
PubMed 29663330
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT02459405
- Acronym / sponsor ID
- 10/H0724/13
- Conditions
- Anastomotic Leak
- Keywords
- Colorectal surgery, Near infrared, Indocyanine green, anastomotic leak, Prevention of leak
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, University College Dublin
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIR anastomotic perfusion assessment | Experimental | Procedure: NIR anastomotic perfusion assessment, Device: Near infrared cameraPatient will have their anastomosis assessed after they receive 7.5 to 9 mg of Indocyanine green intravenously (at a concentration of 2.5mg/ml). The microvascularisation assessment will be performed using a near infrared device(Pinpoint device), allowing to increase reality. This procedure will be repeated twice during the surgery, the first time before and the second time after the anastomosis has been done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIR anastomotic perfusion assessmentAlso: Indocyanine assessment of anastomotic microvascularisationPatient will have their anastomosis assessed by near infrared technology after indocyanine green has been injected i.v. The procedure will be repeated twice, once before the anastomosis and the second time after the anastomosis has been performed. | Procedure or surgery | NIR anastomotic perfusion assessment |
| Near infrared cameraAlso: Pinpoint evaluationUse of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green | Device | NIR anastomotic perfusion assessment |
Primary outcome
Anastomotic leak rate
Time frame: first 30 days
anastomotic leak rate at 30 post operative days
5 secondary outcomes
Time to perform the near infrared procedure
Time frame: during surgery
Time to get a near infrared signal
Time frame: during surgery
complication rate
Time frame: 30 days
Mortality
Time frame: 30 days
Alteration of the course of surgery due to insufficient vascularisation
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Background: PubMed 24566744Ris 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.
- Background: PubMed 22098511Cahill 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.
- Derived from this study: PubMed 41479254Clough EJ, Nightingale K, Smith S, Burke JR. Investigating the Benefit of Fluorescence in Acute Mesenteric Ischaemia: A Systematic Review and Narrative Synthesis. ANZ J Surg. 2026 Apr;96(4):733-741. doi: 10.1111/ans.70433. Epub 2026 Jan 1.
- Derived from this study: PubMed 29663330Ris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Ris, MD, Prof principal investigator
University Hospital, Geneva
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NIR anastomotic perfusion assessment and Near infrared camera in people with Anastomotic Leak, run by University Hospital, Geneva at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ireland, Italy, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak rate (time frame: first 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459405, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.