Colorectal Cancer (CRC)NCT07423130
Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery
An observational study of Colorectal Cancer (CRC) and Rectal Cancer Surgery, run by Jagiellonian University at 1 site in Poland.
Trial summary
Anastomotic leakage remains a major complication after colorectal cancer surgery. Indocyanine green fluorescence angiography (ICG-FA) allows real-time intraoperative assessment of bowel perfusion; however, its clinical impact remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC), Rectal Cancer Surgery, Sigmoid Colon Cancer
- How many people
- 115 participants
- Where
- 1 sitePoland
- Study dates
- 9 Oct 2023to 15 Jul 2025
- Phase
- Observational
- 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
Study population: Adult patients undergoing elective laparoscopic resection for sigmoid or rectal adenocarcinoma at a single tertiary academic center.
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed or clinically suspected sigmoid or rectal adenocarcinoma
- Elective laparoscopic resection with curative intent and planned colorectal/coloanal anastomosis
- Ability to provide informed consent
Who cannot join
- Pregnancy or breastfeeding
- Known hypersensitivity to indocyanine green or iodine
- Emergency surgery
- Planned end colostomy without anastomosis
- Conversion to open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery: A Prospective Single-Center Observational Study With a Historical Control Group
Anastomotic leakage remains a major complication after colorectal cancer surgery. Indocyanine green fluorescence angiography (ICG-FA) allows real-time intraoperative assessment of bowel perfusion; however, its clinical impact remains controversial.
This prospective single-center observational study evaluated the association between intraoperative use of ICG-FA and postoperative outcomes in patients undergoing laparoscopic sigmoid or rectal cancer surgery. Outcomes of patients assessed with ICG-FA were compared with those of a historical control cohort treated without fluorescence imaging.
Read the detailed description
This was a prospective, single-center observational cohort study conducted at a tertiary academic surgical center. Adult patients undergoing elective laparoscopic resection for sigmoid or rectal adenocarcinoma were included. In the prospective cohort, indocyanine green fluorescence angiography was used intraoperatively to assess bowel perfusion prior to anastomosis creation. The decision to modify the transection line was left to the operating surgeon based on fluorescence imaging.
Study outcomes in the ICG-FA cohort were compared with a historical control group of patients who underwent similar laparoscopic procedures without fluorescence imaging during an earlier period at the same institution. The primary outcome was the incidence of anastomotic leakage within 30 days after surgery, defined according to the International Study Group of Rectal Cancer criteria. Secondary outcomes included anastomotic stricture diagnosed during follow-up, postoperative complications, reoperation rate, length of hospital stay, and 30-day mortality.
All patients were treated according to standard institutional perioperative protocols. Data were collected prospectively for the ICG-FA cohort and retrospectively for the control cohort. The study was approved by the local Research Ethics Board, and all procedures were performed in accordance with the Declaration of Helsinki.
- Keywords
- Indocyanine Green, Fluorescence Angiography, Anastomotic Leakage, Anastomotic Stricture, Laparoscopic Colorectal Surgery
- Medical subject headings
- Colorectal Neoplasms, Sigmoid Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICG-FA group | Prospective cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery with intraoperative indocyanine green fluorescence angiography for bowel perfusion assessment. | |
| Control group | Historical control cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery without fluorescence imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Leakage Rate
Incidence of anastomotic leakage defined according to the International Study Group of Rectal Cancer criteria.
Measured: Within 30 days after surgery
Secondary outcomes (6)
Overall Postoperative Complications
Postoperative complications assessed according to the Clavien-Dindo classification.
Measured: Within 30 days after surgery
Postoperative Anastomotic Stricture
Incidence of anastomotic stricture diagnosed endoscopically or radiologically during postoperative follow-up.
Measured: Up to 6 months after surgery
Non-elective Reoperation
Incidence of unplanned reoperations within 30 days following primary surgery.
Measured: Within 30 days after surgery
Length of Hospital Stay
Length of postoperative hospital stay measured in days.
Measured: Up to 60 days
Hospital Readmission
Incidence of hospital readmission within 30 days after discharge.
Measured: Within 30 days after discharge
30-day All-cause Mortality
All-cause mortality occurring within 30 days after surgery.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start9 Oct 2023
- Primary completion15 Feb 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Rubinkiewicz, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423130
- Sponsor's protocol ID
- ICG-FA-CRC-UH-Krakow-2023
- Other IDs
- 1072.6120.59.2023
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Semeniv S, Pedziwiatr M, Rymarowicz J, Szpakowska A, Jurczak M, Putowski M, Rubinkiewicz M. Indocyanine green fluorescence angiography in laparoscopic sigmoid and rectal cancer surgery: no reduction in anastomotic leakage but a lower incidence of anastomotic strictures. A prospective single-center study. Front Surg. 2026 Jun 25;13:1822071. doi: 10.3389/fsurg.2026.1822071. eCollection 2026.
PubMed 42428782
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery: A Prospective Single-Center Observational Study With a Historical Control Group
- ClinicalTrials.gov ID
- NCT07423130
- Acronym / sponsor ID
- ICG-FA-CRC-UH-Krakow-2023
- Keywords
- Indocyanine Green, Fluorescence Angiography, Anastomotic Leakage, Anastomotic Stricture, Laparoscopic Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 20 Feb 2026 (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.
Anastomotic leakage remains a major complication after colorectal cancer surgery. Indocyanine green fluorescence angiography (ICG-FA) allows real-time intraoperative assessment of bowel perfusion; however, its clinical impact remains controversial.
This prospective single-center observational study evaluated the association between intraoperative use of ICG-FA and postoperative outcomes in patients undergoing laparoscopic sigmoid or rectal cancer surgery. Outcomes of patients assessed with ICG-FA were compared with those of a historical control cohort treated without fluorescence imaging.
Detailed description
This was a prospective, single-center observational cohort study conducted at a tertiary academic surgical center. Adult patients undergoing elective laparoscopic resection for sigmoid or rectal adenocarcinoma were included. In the prospective cohort, indocyanine green fluorescence angiography was used intraoperatively to assess bowel perfusion prior to anastomosis creation. The decision to modify the transection line was left to the operating surgeon based on fluorescence imaging.
Study outcomes in the ICG-FA cohort were compared with a historical control group of patients who underwent similar laparoscopic procedures without fluorescence imaging during an earlier period at the same institution. The primary outcome was the incidence of anastomotic leakage within 30 days after surgery, defined according to the International Study Group of Rectal Cancer criteria. Secondary outcomes included anastomotic stricture diagnosed during follow-up, postoperative complications, reoperation rate, length of hospital stay, and 30-day mortality.
All patients were treated according to standard institutional perioperative protocols. Data were collected prospectively for the ICG-FA cohort and retrospectively for the control cohort. The study was approved by the local Research Ethics Board, and all procedures were performed in accordance with the Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG-FA group | – | –Prospective cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery with intraoperative indocyanine green fluorescence angiography for bowel perfusion assessment. |
| Control group | – | –Historical control cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery without fluorescence imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective laparoscopic resection for sigmoid or rectal adenocarcinoma at a single tertiary academic center.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Histologically confirmed or clinically suspected sigmoid or rectal adenocarcinoma
- Elective laparoscopic resection with curative intent and planned colorectal/coloanal anastomosis
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- Known hypersensitivity to indocyanine green or iodine
- Emergency surgery
- Planned end colostomy without anastomosis
- Conversion to open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anastomotic Leakage Rate
Time frame: Within 30 days after surgery
Incidence of anastomotic leakage defined according to the International Study Group of Rectal Cancer criteria.
6 secondary outcomes
Overall Postoperative Complications
Time frame: Within 30 days after surgery
Postoperative Anastomotic Stricture
Time frame: Up to 6 months after surgery
Non-elective Reoperation
Time frame: Within 30 days after surgery
Length of Hospital Stay
Time frame: Up to 60 days
Hospital Readmission
Time frame: Within 30 days after discharge
30-day All-cause Mortality
Time frame: Within 30 days after 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 20 Feb 2026.
- Derived from this study: PubMed 42428782Semeniv S, Pedziwiatr M, Rymarowicz J, Szpakowska A, Jurczak M, Putowski M, Rubinkiewicz M. Indocyanine green fluorescence angiography in laparoscopic sigmoid and rectal cancer surgery: no reduction in anastomotic leakage but a lower incidence of anastomotic strictures. A prospective single-center study. Front Surg. 2026 Jun 25;13:1822071. doi: 10.3389/fsurg.2026.1822071. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (CRC) and Rectal Cancer Surgery, run by Jagiellonian University at 1 site in Poland.
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 5 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 20 Feb 2026. 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 Poland. 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.
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 Leakage Rate (time frame: Within 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 NCT07423130, which also lists 1 linked publication.
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 20 Feb 2026.