Colon NeoplasmsPhase 2/3NCT02598414
The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery
A Phase 2/3 study testing Near-infrared ICG fluorescence imaging, Traditional bowel anastomosis and FireFly™ in people with Colon Neoplasms and Rectal Neoplasms, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Neoplasms, Rectal Neoplasms, Inflammatory Bowel Disease
- What is being tested?
- Near-infrared ICG fluorescence imaging, Traditional bowel anastomosis and FireFly™
- 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
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2015to Dec 2017
- Phase
- Phase 2/3
- 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
- Subject is able to give informed consent for participation in the study
- Subject is willing and able to comply with the study procedures
- Subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision
- Subject is scheduled for robotic colon or rectal resection
- A negative pregnancy test for women of childbearing potential prior to surgery
Who cannot join
- Subjects present with bowel obstruction or perforation
- Subject undergo emergency surgery
- Subject with ASA IV, V
- History of allergy or hypersensitivity against indocyanine green
- Pregnant or breast-feeding women
- Subject has uremia (serum creatinine >2.5 mg/dl)
Show all 9Show fewer
- Subject is undergoing palliative surgery or who is terminally ill
- Subject who is unable to discontinue warfarin anticoagulation 5 days before surgery
- Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University
Istanbul
norgaz, MD, tnorgaz@yahoo.com
Ali Buturak, MD
About this study
Official title: The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial
In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time.
Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.
- Being tested
- Near-infrared ICG fluorescence imaging, Traditional bowel anastomosis, FireFly™
- Keywords
- Colorectal Disease, Robotic Surgery, Indocyanine Green Fluorescence Imaging, Anastomotic Leak, Short-term Outcomes
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Inflammatory Bowel Diseases, Diverticular Diseases, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared ICG fluorescence imagingProcedure or surgery
Also called Near-infrared fluorescence imaging, Indocyanine green
Patient will have their bowel anastomosis assessed intraoperatively by near-infrared technology after indocyanine green has been injected intravenously at a concentration of 2.5 mg/ml. This procedure will be repeated twice during surgery, the first time before and the second time after the anastomosis has been done. The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
Traditional bowel anastomosisProcedure or surgery
Traditional bowel anastomosis will be performed without ICG fluorescence imaging.
FireFly™Device
The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
| Study group | Role | What they receive |
|---|---|---|
| Bowel Anastomosis Under ICG Guidance | Experimental | Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging. Receives: Procedure: Near-infrared ICG fluorescence imaging; Device: FireFly™ |
| Standard Bowel Anastomosis | Active comparator | Patients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging. Receives: Procedure: Traditional bowel anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak rate
Anastomotic leak rate within 30 post operative days
Measured: Postoperative 30 days
Secondary outcomes (2)
Complication rate
Complication rate within postoperative 30 days
Measured: Postoperative 30 days
Mortality
Mortality within 30 post operative days
Measured: Postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmsStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem Atakent University Hospital
- Responsible party
- Sponsor
- Investigators
- Bilgi Baca, MD,Prof.Dr., Principal investigator, Department of General Surgery, Acibadem University, Atakent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598414
- Sponsor's protocol ID
- ICG-COLORECTAL
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 24566744Jafari MD, Wexner SD, Martz JE, McLemore EC, Margolin DA, Sherwinter DA, Lee SW, Senagore AJ, Phelan MJ, Stamos MJ. Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study. J Am Coll Surg. 2015 Jan;220(1):82-92.e1. doi: 10.1016/j.jamcollsurg.2014.09.015. Epub 2014 Sep 28.
PubMed 25451666
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02598414
- Acronym / sponsor ID
- ICG-COLORECTAL
- Keywords
- Colorectal Disease, Robotic Surgery, Indocyanine Green Fluorescence Imaging, Anastomotic Leak, Short-term Outcomes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Acibadem Atakent University Hospital
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Nov 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.
In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time.
Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bowel Anastomosis Under ICG Guidance | Experimental | Procedure: Near-infrared ICG fluorescence imaging, Device: FireFly™Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging. |
| Standard Bowel Anastomosis | Active comparator | Procedure: Traditional bowel anastomosisPatients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is able to give informed consent for participation in the study
- Subject is willing and able to comply with the study procedures
- Subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision
- Subject is scheduled for robotic colon or rectal resection
- A negative pregnancy test for women of childbearing potential prior to surgery
Key exclusion criteria (9 listed)
- Subjects present with bowel obstruction or perforation
- Subject undergo emergency surgery
- Subject with ASA IV, V
- History of allergy or hypersensitivity against indocyanine green
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Near-infrared ICG fluorescence imagingAlso: Near-infrared fluorescence imaging, Indocyanine greenPatient will have their bowel anastomosis assessed intraoperatively by near-infrared technology after indocyanine green has been injected intravenously at a concentration of 2.5 mg/ml. This procedure will be repeated twice during surgery, the first time before and the second time after the anastomosis has been done. The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™). | Procedure or surgery | Bowel Anastomosis Under ICG Guidance |
| Traditional bowel anastomosisTraditional bowel anastomosis will be performed without ICG fluorescence imaging. | Procedure or surgery | Standard Bowel Anastomosis |
| FireFly™The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™). | Device | Bowel Anastomosis Under ICG Guidance |
Primary outcome
Anastomotic leak rate
Time frame: Postoperative 30 days
Anastomotic leak rate within 30 post operative days
2 secondary outcomes
Complication rate
Time frame: Postoperative 30 days
Mortality
Time frame: Postoperative 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Results publication: 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.
- Results publication: PubMed 25451666Jafari MD, Wexner SD, Martz JE, McLemore EC, Margolin DA, Sherwinter DA, Lee SW, Senagore AJ, Phelan MJ, Stamos MJ. Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study. J Am Coll Surg. 2015 Jan;220(1):82-92.e1. doi: 10.1016/j.jamcollsurg.2014.09.015. Epub 2014 Sep 28.
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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.
Bilgi Baca, MD,Prof.Dr. principal investigator
Department of General Surgery, Acibadem University, Atakent Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Near-infrared ICG fluorescence imaging, Traditional bowel anastomosis and FireFly™ in people with Colon Neoplasms and Rectal Neoplasms, run by Acibadem University at 1 site in Turkey (Türkiye).
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 9 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: status not confirmed, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Volkan Ozben, MD (+905346484678, volkanozben@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak rate (time frame: Postoperative 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 NCT02598414, which also lists 2 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 24 Nov 2015.