Gynecologic CancersPhase 4INOCANCT06871787
Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery
A Phase 4 study testing Indocyanine Green and Near-Infrared Fluorescence Imaging System in people with Gynecologic Cancers and Ovarian Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations. The main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers, Ovarian Cancer, Endometrial Cancers
- What is being tested?
- Indocyanine Green and Near-Infrared Fluorescence Imaging System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older.
- Diagnosis of gynecologic cancer (ovarian, endometrial, cervical, vulvar) requiring surgical treatment.
- Planned bowel resection and anastomosis during gynecologic oncology surgery.
- Ability and willingness to provide informed consent.
Who cannot join
- Known allergy or hypersensitivity to indocyanine green (ICG).
- Pregnancy or breastfeeding at the time of surgery.
- Severe liver or kidney dysfunction limiting the use of ICG.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine, Department of Gynecologic Oncology
Istanbul, Istanbul, 34093
Yagmur Minareci, Assist. Prof., +905053574361, dryagmurminareci@gmail.com
Atahan Toyran, Medical Doctor
About this study
Official title: Evaluation of Bowel Anastomoses During Gynecologic Oncology Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green
The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations.
The main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment.
Researchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.
Read the detailed description
In gynecologic cancer surgeries, complete removal of the tumor often requires bowel resection (removal of part of the intestine). After resection, surgeons perform bowel anastomosis to restore gastrointestinal continuity. However, anastomosis can sometimes fail, leading to complications such as leaks, pelvic abscesses, or infections. Such complications significantly affect patient health, recovery, and outcomes.
Indocyanine green (ICG) is a dye approved by health authorities for clinical use. When injected into the bloodstream, it glows brightly under near-infrared (NIR) light, allowing investigators to visually assess blood flow in tissues during surgery. Good blood flow is critical for proper healing of the bowel reconnection.
This study aims to evaluate the effectiveness of using ICG-enhanced NIR fluorescence imaging specifically during gynecologic oncology surgeries involving bowel resections. After surgeons complete the anastomosis, ICG will be administered intravenously. Investigators will then examine the blood flow at the anastomosis site using a special near-infrared camera. If the blood flow appears insufficient, investigators may choose to revise the bowel connection during the same operation.
The study will include approximately 50 women undergoing surgery for gynecologic cancers such as ovarian, uterine, cervical, or vulvar cancer. The primary goal is to determine whether the use of this imaging technique reduces complications, especially within the first 30 days after surgery.
The results of this research could lead to safer surgical procedures, improved patient outcomes, and potentially influence clinical practice guidelines in gynecologic oncology.
- Conditions
- Gynecologic Cancers, Ovarian Cancer, Endometrial Cancers, Cervical Cancers, Vulvar Cancer, Anastomotic Leaks
- Being tested
- Indocyanine Green, Near-Infrared Fluorescence Imaging System
- Keywords
- Indocyanine Green, Near-Infrared Imaging, Bowel Anastomosis, Gynecologic Oncology, Anastomotic Complications, Perfusion Assessment
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Indocyanine green (ICG), administered intravenously at a dose of 2.5 mg/ml, will be used during surgery to evaluate bowel anastomosis perfusion through near-infrared fluorescence imaging.
Near-Infrared Fluorescence Imaging SystemDevice
A near-infrared fluorescence imaging device will be used intraoperatively to visualize indocyanine green (ICG) fluorescence, assessing the perfusion of bowel anastomoses during gynecologic oncology surgery.
| Study group | Role | What they receive |
|---|---|---|
| ICG Fluorescence Imaging Group | Experimental | Women undergoing gynecologic oncology surgery with bowel resection and anastomosis. Anastomotic perfusion will be evaluated intraoperatively using indocyanine green (ICG) enhanced near-infrared fluorescence imaging. Receives: Drug: Indocyanine Green; Device: Near-Infrared Fluorescence Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Anastomotic Complications within 30 Days After Surgery
The primary outcome will be the incidence of anastomotic leaks, pelvic abscesses, and infections observed within 30 days following bowel anastomosis performed during gynecologic oncology surgery with indocyanine green-enhanced near-infrared fluorescence imaging.
Measured: 30 days after surgery
Secondary outcomes (1)
Number of Anastomoses Revised After Indocyanine Green Fluorescence Imaging
The secondary outcome will evaluate how frequently the bowel anastomosis site was revised intraoperatively due to insufficient perfusion as detected by indocyanine green-enhanced near-infrared fluorescence imaging.
Measured: Intraoperative (During Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- More trials run by Istanbul 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atahan Toyran, Istanbul University
- Investigators
- Samet Topuz, Prof., Study chair, Istanbul UniversityYagmur Minareci, Assist. Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871787
- Sponsor's protocol ID
- 07.01.2025-3097444
- Acronym
- INOCA
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: A decision regarding individual participant data (IPD) sharing has not yet been made. Data sharing will be considered upon completion of the study and publication of results.
Publications
Emile SH, Khan SM, Wexner SD. Impact of change in the surgical plan based on indocyanine green fluorescence angiography on the rates of colorectal anastomotic leak: a systematic review and meta-analysis. Surg Endosc. 2022 Apr;36(4):2245-2257. doi: 10.1007/s00464-021-08973-2. Epub 2022 Jan 13.
PubMed 35024926Chan DKH, Lee SKF, Ang JJ. Indocyanine green fluorescence angiography decreases the risk of colorectal anastomotic leakage: Systematic review and meta-analysis. Surgery. 2020 Dec;168(6):1128-1137. doi: 10.1016/j.surg.2020.08.024. Epub 2020 Oct 1.
PubMed 33010938Parthasarathy M, Greensmith M, Bowers D, Groot-Wassink T. Risk factors for anastomotic leakage after colorectal resection: a retrospective analysis of 17 518 patients. Colorectal Dis. 2017 Mar;19(3):288-298. doi: 10.1111/codi.13476.
PubMed 27474844BRUNSCHWIG A. Complete excision of pelvic viscera for advanced carcinoma; a one-stage abdominoperineal operation with end colostomy and bilateral ureteral implantation into the colon above the colostomy. Cancer. 1948 Jul;1(2):177-83. doi: 10.1002/1097-0142(194807)1:23.0.co;2-a. No abstract available.
PubMed 18875031Grimm C, Harter P, Alesina PF, Prader S, Schneider S, Ataseven B, Meier B, Brunkhorst V, Hinrichs J, Kurzeder C, Heitz F, Kahl A, Traut A, Groeben HT, Walz M, du Bois A. The impact of type and number of bowel resections on anastomotic leakage risk in advanced ovarian cancer surgery. Gynecol Oncol. 2017 Sep;146(3):498-503. doi: 10.1016/j.ygyno.2017.06.007. Epub 2017 Jun 10.
PubMed 28610745Harter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, Kim JW, Raspagliesi F, Lampe B, Aletti G, Meier W, Cibula D, Mustea A, Mahner S, Runnebaum IB, Schmalfeldt B, Burges A, Kimmig R, Scambia G, Greggi S, Hilpert F, Hasenburg A, Hillemanns P, Giorda G, von Leffern I, Schade-Brittinger C, Wagner U, du Bois A. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019 Feb 28;380(9):822-832. doi: 10.1056/NEJMoa1808424.
PubMed 30811909Morales-Conde S, Alarcon I, Yang T, Licardie E, Camacho V, Aguilar Del Castillo F, Balla A. Fluorescence angiography with indocyanine green (ICG) to evaluate anastomosis in colorectal surgery: where does it have more value? Surg Endosc. 2020 Sep;34(9):3897-3907. doi: 10.1007/s00464-019-07159-1. Epub 2019 Oct 4.
PubMed 31586247
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bowel Anastomoses During Gynecologic Oncology Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green
- ClinicalTrials.gov ID
- NCT06871787
- Acronym / sponsor ID
- INOCA / 07.01.2025-3097444
- Conditions
- Gynecologic Cancers, Ovarian Cancer, Endometrial Cancers, Cervical Cancers, Vulvar Cancer, Anastomotic Leaks
- Keywords
- Indocyanine Green, Near-Infrared Imaging, Bowel Anastomosis, Gynecologic Oncology, Anastomotic Complications, Perfusion Assessment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 12 Mar 2025 (actual)
- 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.
The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations.
The main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment.
Researchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.
Detailed description
In gynecologic cancer surgeries, complete removal of the tumor often requires bowel resection (removal of part of the intestine). After resection, surgeons perform bowel anastomosis to restore gastrointestinal continuity. However, anastomosis can sometimes fail, leading to complications such as leaks, pelvic abscesses, or infections. Such complications significantly affect patient health, recovery, and outcomes.
Indocyanine green (ICG) is a dye approved by health authorities for clinical use. When injected into the bloodstream, it glows brightly under near-infrared (NIR) light, allowing investigators to visually assess blood flow in tissues during surgery. Good blood flow is critical for proper healing of the bowel reconnection.
This study aims to evaluate the effectiveness of using ICG-enhanced NIR fluorescence imaging specifically during gynecologic oncology surgeries involving bowel resections. After surgeons complete the anastomosis, ICG will be administered intravenously. Investigators will then examine the blood flow at the anastomosis site using a special near-infrared camera. If the blood flow appears insufficient, investigators may choose to revise the bowel connection during the same operation.
The study will include approximately 50 women undergoing surgery for gynecologic cancers such as ovarian, uterine, cervical, or vulvar cancer. The primary goal is to determine whether the use of this imaging technique reduces complications, especially within the first 30 days after surgery.
The results of this research could lead to safer surgical procedures, improved patient outcomes, and potentially influence clinical practice guidelines in gynecologic oncology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG Fluorescence Imaging Group | Experimental | Drug: Indocyanine Green, Device: Near-Infrared Fluorescence Imaging SystemWomen undergoing gynecologic oncology surgery with bowel resection and anastomosis. Anastomotic perfusion will be evaluated intraoperatively using indocyanine green (ICG) enhanced near-infrared fluorescence imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18 years or older.
- Diagnosis of gynecologic cancer (ovarian, endometrial, cervical, vulvar) requiring surgical treatment.
- Planned bowel resection and anastomosis during gynecologic oncology surgery.
- Ability and willingness to provide informed consent.
Key exclusion criteria (3 listed)
- Known allergy or hypersensitivity to indocyanine green (ICG).
- Pregnancy or breastfeeding at the time of surgery.
- Severe liver or kidney dysfunction limiting the use of ICG.
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 |
|---|---|---|
| Indocyanine GreenIndocyanine green (ICG), administered intravenously at a dose of 2.5 mg/ml, will be used during surgery to evaluate bowel anastomosis perfusion through near-infrared fluorescence imaging. | Drug | ICG Fluorescence Imaging Group |
| Near-Infrared Fluorescence Imaging SystemA near-infrared fluorescence imaging device will be used intraoperatively to visualize indocyanine green (ICG) fluorescence, assessing the perfusion of bowel anastomoses during gynecologic oncology surgery. | Device | ICG Fluorescence Imaging Group |
Primary outcome
Rate of Anastomotic Complications within 30 Days After Surgery
Time frame: 30 days after surgery
The primary outcome will be the incidence of anastomotic leaks, pelvic abscesses, and infections observed within 30 days following bowel anastomosis performed during gynecologic oncology surgery with indocyanine green-enhanced near-infrared fluorescence imaging.
1 secondary outcome
Number of Anastomoses Revised After Indocyanine Green Fluorescence Imaging
Time frame: Intraoperative (During Surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 35024926Emile SH, Khan SM, Wexner SD. Impact of change in the surgical plan based on indocyanine green fluorescence angiography on the rates of colorectal anastomotic leak: a systematic review and meta-analysis. Surg Endosc. 2022 Apr;36(4):2245-2257. doi: 10.1007/s00464-021-08973-2. Epub 2022 Jan 13.
- Background: PubMed 33010938Chan DKH, Lee SKF, Ang JJ. Indocyanine green fluorescence angiography decreases the risk of colorectal anastomotic leakage: Systematic review and meta-analysis. Surgery. 2020 Dec;168(6):1128-1137. doi: 10.1016/j.surg.2020.08.024. Epub 2020 Oct 1.
- Background: PubMed 27474844Parthasarathy M, Greensmith M, Bowers D, Groot-Wassink T. Risk factors for anastomotic leakage after colorectal resection: a retrospective analysis of 17 518 patients. Colorectal Dis. 2017 Mar;19(3):288-298. doi: 10.1111/codi.13476.
- Background: PubMed 18875031BRUNSCHWIG A. Complete excision of pelvic viscera for advanced carcinoma; a one-stage abdominoperineal operation with end colostomy and bilateral ureteral implantation into the colon above the colostomy. Cancer. 1948 Jul;1(2):177-83. doi: 10.1002/1097-0142(194807)1:23.0.co;2-a. No abstract available.
- Background: PubMed 28610745Grimm C, Harter P, Alesina PF, Prader S, Schneider S, Ataseven B, Meier B, Brunkhorst V, Hinrichs J, Kurzeder C, Heitz F, Kahl A, Traut A, Groeben HT, Walz M, du Bois A. The impact of type and number of bowel resections on anastomotic leakage risk in advanced ovarian cancer surgery. Gynecol Oncol. 2017 Sep;146(3):498-503. doi: 10.1016/j.ygyno.2017.06.007. Epub 2017 Jun 10.
- Background: PubMed 30811909Harter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, Kim JW, Raspagliesi F, Lampe B, Aletti G, Meier W, Cibula D, Mustea A, Mahner S, Runnebaum IB, Schmalfeldt B, Burges A, Kimmig R, Scambia G, Greggi S, Hilpert F, Hasenburg A, Hillemanns P, Giorda G, von Leffern I, Schade-Brittinger C, Wagner U, du Bois A. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019 Feb 28;380(9):822-832. doi: 10.1056/NEJMoa1808424.
- Results publication: PubMed 31586247Morales-Conde S, Alarcon I, Yang T, Licardie E, Camacho V, Aguilar Del Castillo F, Balla A. Fluorescence angiography with indocyanine green (ICG) to evaluate anastomosis in colorectal surgery: where does it have more value? Surg Endosc. 2020 Sep;34(9):3897-3907. doi: 10.1007/s00464-019-07159-1. Epub 2019 Oct 4.
- Individual participant dataSharing planned: Undecided. A decision regarding individual participant data (IPD) sharing has not yet been made. Data sharing will be considered upon completion of the study and publication of results.
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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.
Samet Topuz, Prof. study chair
Istanbul University
Yagmur Minareci, Assist. Prof. study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine Green and Near-Infrared Fluorescence Imaging System in people with Gynecologic Cancers and Ovarian Cancer, run by Istanbul 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Mar 2025. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atahan Toyran, Medical Doctor (+905057146233, atahan.toyran@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Anastomotic Complications within 30 Days After Surgery (time frame: 30 days after surgery). 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 NCT06871787, which also lists 7 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 14 Mar 2025.