Rectal CancerNCT07916532
Indocyanine Green Lymphatic Mapping in Minimally Invasive Sigmoid and Rectal Cancer Surgery
A study testing Intraoperative ICG-Guided Lymphatic Mapping in people with Rectal Cancer and Sigmoid Colon Cancer, run by Jagiellonian University at 1 site in Poland.
Trial summary
This prospective, single-center, non-randomized study with a historical control group evaluated the clinical utility of indocyanine green-guided lymphatic mapping (ICG-LM) during minimally invasive surgery for sigmoid colon and rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Sigmoid Colon Cancer
- What is being tested?
- Intraoperative ICG-Guided Lymphatic Mapping
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 sitePoland
- Study dates
- 8 Oct 2023to 30 Sep 2026
- Phase
- Interventional
- 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
- Age 18 years or older.
- Histologically confirmed or clinically suspected primary adenocarcinoma of the sigmoid colon or rectum.
- Resectable disease (cT1-T4b, N0-3, M0), according to the AJCC TNM classification, 8th edition.
- Eligibility for curative-intent minimally invasive surgical resection (laparoscopic or robotic), either as initial treatment or following neoadjuvant therapy.
Who cannot join
- Unresectable distant metastases identified on preoperative imaging.
- Pregnancy or breastfeeding.
- Known allergy to iodine-containing compounds or previous adverse reactions to indocyanine green (ICG).
- Intraoperative Exclusion Criteria:
- Intraoperative identification of unresectable metastatic disease.
- Conversion to open surgery.
- Final histopathological diagnosis inconsistent with adenocarcinoma.
Trial locations and contacts
1 site in 1 country.
Poland1 site
University Hospital in Krakow (Szpital Uniwersytecki w Krakowie)
Krakow, Lesser Poland Voivodeship, 30-688
About this study
Official title: Indocyanine Green Lymph Node Mapping During Minimally Invasive Rectosigmoid Cancer Surgery: A Prospective Single-Center Study
This prospective, single-center, non-randomized study with a historical control group evaluated the clinical utility of indocyanine green-guided lymphatic mapping (ICG-LM) during minimally invasive surgery for sigmoid colon and rectal cancer.
Adequate lymph node removal is an essential component of colorectal cancer surgery, as the number of lymph nodes examined influences the accuracy of pathological staging and subsequent treatment decisions. Current oncological recommendations generally support the examination of at least 12 lymph nodes for adequate nodal assessment.
Read more
Indocyanine green is a fluorescent dye that enables visualization of lymphatic drainage pathways using near-infrared imaging. Fluorescence-guided lymphatic mapping may help surgeons identify lymphatic structures and lymph nodes that are not readily visible under conventional imaging.
Patients prospectively enrolled in the intervention group underwent endoscopic submucosal injection of ICG before minimally invasive oncological resection. Intraoperative near-infrared fluorescence imaging was used to visualize lymphatic drainage and guide lymph node identification. Outcomes were compared with those of a historical control group of patients who had undergone standard minimally invasive surgery without fluorescence-guided lymphatic mapping.
The primary outcome was the adequacy of lymphadenectomy, evaluated by the proportion of patients with fewer than 12 lymph nodes retrieved and identified during histopathological examination.
Additional outcomes included the total number of retrieved lymph nodes, metastatic lymph node yield, operative time, and postoperative outcomes.
Propensity score matching and overlap weighting were used to account for differences in baseline characteristics between the intervention and historical control groups.
The study assessed the potential value of ICG-guided lymphatic mapping for improving lymph node assessment during minimally invasive surgery for sigmoid colon and rectal cancer.
Read the detailed description
Background and Rationale
Adequate lymphadenectomy is a fundamental component of curative-intent surgery for colorectal cancer. Accurate pathological assessment of regional lymph nodes is essential for determining disease stage, guiding adjuvant treatment, and estimating prognosis. Retrieval and examination of at least 12 lymph nodes is widely accepted as a benchmark for adequate nodal staging.
Nevertheless, lymph node yield may vary according to patient characteristics, tumor location, previous neoadjuvant treatment, surgical technique, and pathological assessment.
Indocyanine green-guided lymphatic mapping (ICG-LM) is a fluorescence-guided surgical technique that enables visualization of lymphatic drainage pathways using near-infrared imaging. By identifying fluorescent lymphatic structures and lymph nodes, this approach may improve intraoperative recognition of lymphatic drainage patterns and facilitate lymph node retrieval.
Study Design and Population
This was a prospective, single-center, non-randomized comparative study with a historical control group, conducted at the University Hospital in Krakow, Poland.
The study included patients undergoing minimally invasive oncological resection for sigmoid colon or rectal adenocarcinoma.
The intervention group consisted of prospectively enrolled patients who underwent indocyanine green-guided lymphatic mapping during minimally invasive colorectal cancer surgery.
The historical control group consisted of patients who had previously undergone standard minimally invasive oncological resection without ICG-guided lymphatic mapping. Clinical and perioperative data from the historical cohort were used for comparative analysis.
No random allocation was performed.
ICG Administration and Fluorescence-Guided Surgery
Patients in the intervention group underwent intraoperative endoscopic administration of indocyanine green into the submucosal layer surrounding the tumor.
The administered dose was 2.5 mg of ICG, corresponding to 2 mL of a solution with a concentration of 1.25 mg/mL.
During minimally invasive surgery, near-infrared fluorescence imaging was used to visualize lymphatic drainage pathways and fluorescent lymph nodes.
Standard oncological resection and lymphadenectomy were performed according to established surgical principles. Fluorescence imaging served as an adjunct to conventional anatomical dissection rather than a replacement for standard oncological surgery.
The fluorescence-guided technique allowed the surgical team to assess lymphatic drainage patterns and identify potentially relevant lymph nodes.
Study Outcomes
The principal outcome of the comparative analysis was the adequacy of lymphadenectomy, assessed by the proportion of patients with an inadequate lymph node yield, defined as fewer than 12 lymph nodes retrieved and identified during histopathological examination of the surgical specimen.
Additional outcomes included total lymph node yield, the number of metastatic lymph nodes, operative time, and postoperative outcomes, including complications and recovery parameters.
The study also evaluated the technical feasibility of fluorescence-guided lymphatic mapping and the intraoperative visualization of lymphatic drainage pathways.
Statistical Analysis
Because treatment allocation was not randomized and the control group was historical, propensity score-based methods were applied to reduce the influence of differences in baseline patient characteristics.
Propensity score matching (PSM) was performed to construct comparable groups based on relevant demographic and clinical characteristics.
The primary outcome was evaluated by comparing the proportion of patients with fewer than 12 retrieved lymph nodes between the ICG-LM and control groups. Effect estimates were expressed using appropriate measures of association and 95% confidence intervals.
An additional analysis using propensity score overlap weighting was performed to assess the robustness of the findings and improve comparability between treatment groups.
Secondary outcomes were compared using statistical methods appropriate to the type and distribution of each variable.
Study Significance
This study investigated the clinical utility of indocyanine green-guided lymphatic mapping in minimally invasive oncological surgery for sigmoid colon and rectal cancer.
By comparing prospectively enrolled patients undergoing fluorescence-guided surgery with a historical control cohort, the study sought to provide preliminary evidence regarding the relationship between fluorescence-guided lymphatic mapping, adequacy of lymphadenectomy, and perioperative outcomes.
- Conditions
- Rectal Cancer, Sigmoid Colon Cancer
- Being tested
- Intraoperative ICG-Guided Lymphatic Mapping
- Keywords
- Indocyanine Green, ICG-Guided Lymphatic Mapping, Near-Infrared Fluorescence Imaging, Fluorescence-Guided Surgery, Lymphadenectomy, Lymph Node Yield, Adequacy of Lymphadenectomy, Minimally Invasive Colorectal Surgery
- Medical subject headings
- Rectal Neoplasms, Sigmoid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ICG-Guided Lymphatic MappingProcedure or surgery
Intraoperative lymphatic mapping using indocyanine green (ICG) during minimally invasive oncological resection for sigmoid colon or rectal cancer. Under general anesthesia, before surgical resection, ICG was administered endoscopically into the submucosal layer around the tumor using a 23-gauge injection needle introduced through the working channel of a flexible endoscope. A total of 2.5 mg of ICG (2 mL of a 1.25 mg/mL solution) was injected at four peritumoral sites (0.5 mL per site). After completion of standard oncological resection, near-infrared fluorescence imaging was used to visualize lymphatic drainage and identify fluorescent lymph nodes outside the standard dissection field. These additional lymph nodes were removed separately for histopathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative ICG-Guided Lymphatic Mapping | Experimental | Patients with sigmoid colon or rectal cancer undergoing minimally invasive oncological resection with intraoperative indocyanine green (ICG)-guided lymphatic mapping. ICG was administered intraoperatively at a total dose of 2.5 mg, corresponding to 2 mL of a solution with a concentration of 1.25 mg/mL. Near-infrared fluorescence imaging was used to visualize lymphatic drainage pathways and identify fluorescent lymph nodes, including those outside the expected lymphatic drainage territory. Fluorescence findings were used to guide intraoperative assessment of lymphatic drainage and identify potential aberrant drainage pathways. Receives: Procedure: Intraoperative ICG-Guided Lymphatic Mapping |
| Historical Control Group - Standard Surgery | No intervention | Patients with sigmoid colon or rectal cancer who underwent minimally invasive oncological resection without indocyanine green (ICG)-guided lymphatic mapping. This historical control group consisted of patients treated at the same institution before implementation of the ICG lymphatic mapping protocol. All patients underwent standard oncological resection with lymphadenectomy according to established surgical principles. No ICG was administered for lymphatic mapping, and no fluorescence-guided lymph node identification was performed. Data were collected retrospectively from institutional medical records for comparison with the prospectively enrolled ICG-LM group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Inadequate Lymphadenectomy
The proportion of patients with inadequate lymphadenectomy, defined as retrieval of fewer than 12 lymph nodes in the surgical specimen, as determined by final histopathological examination. This outcome will be compared between patients undergoing minimally invasive colorectal cancer surgery with intraoperative indocyanine green-guided lymphatic mapping (ICG-LM) and a historical control group undergoing standard minimally invasive surgery without ICG-LM.
Measured: From surgery to final histopathological assessment (approximately 30 days after surgery).
Secondary outcomes (9)
Total Number of Retrieved Lymph Nodes
The total number of lymph nodes retrieved from the surgical specimen, as determined by final histopathological examination. The number of retrieved lymph nodes will be compared between the ICG-guided lymphatic mapping group and the historical control group undergoing standard minimally invasive colorectal cancer surgery.
Measured: From surgery to final histopathological assessment (approximately 30 days after surgery).
Successful Lymphatic Mapping Rate
The proportion of patients in the ICG-LM group in whom fluorescent lymphatic drainage pathways or lymph nodes were successfully visualized using near-infrared fluorescence imaging during minimally invasive colorectal cancer surgery. Mapping success will be expressed as the percentage of patients with successful visualization among all patients who received ICG.
Measured: Intraoperatively, during the index surgical procedure.
Aberrant Lymphatic Drainage Rate
The proportion of patients with successfully visualized lymphatic drainage in whom ICG fluorescence imaging identified lymphatic drainage pathways outside the expected anatomical drainage territory. Aberrant drainage patterns will be assessed intraoperatively and reported as a percentage of patients with successful lymphatic mapping.
Measured: Intraoperatively, during the index surgical procedure.
Number of Additional Lymph Nodes Identified Through ICG Mapping
The number of additional lymph nodes identified and retrieved based on intraoperative ICG fluorescence imaging, including lymph nodes located outside the expected lymphatic drainage territory. Retrieved lymph nodes will undergo histopathological examination to determine the presence or absence of metastatic involvement.
Measured: From surgery to final histopathological assessment (approximately 30 days after surgery).
Postoperative Complications
The incidence and severity of postoperative complications assessed using the Clavien-Dindo classification (grades I-V). Complication rates and severity will be compared between the ICG-LM group and the historical control group.
Measured: Within 30 days after surgery.
Length of Postoperative Hospital Stay
The number of days from the index surgical procedure to hospital discharge, compared between the ICG-LM group and the historical control group.
Measured: From the date of surgery to hospital discharge (length of postoperative hospital stay, measured in days, on average, less than 30 days).
Hospital Readmission Within 30 Days
The proportion of patients requiring unplanned hospital readmission within 30 days after the index surgical procedure.
Measured: Within 30 days after surgery.
30-Day Mortality
The proportion of patients who died from any cause within 30 days following the index surgical procedure.
Measured: Within 30 days after surgery.
Reoperation Within 30 Days
The proportion of patients requiring an additional surgical intervention within 30 days after the index surgical procedure.
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 posted4 Nov 2026
- Study start8 Oct 2023
- Primary completion31 Aug 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Solomiia Semeniv, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916532
- Sponsor's protocol ID
- UJCM-ICG-LM-2023
- Other IDs
- 1072.6120.59.2023
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to patient confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Lymph Node Mapping During Minimally Invasive Rectosigmoid Cancer Surgery: A Prospective Single-Center Study
- ClinicalTrials.gov ID
- NCT07916532
- Acronym / sponsor ID
- UJCM-ICG-LM-2023
- Conditions
- Rectal Cancer, Sigmoid Colon Cancer
- Keywords
- Indocyanine Green, ICG-Guided Lymphatic Mapping, Near-Infrared Fluorescence Imaging, Fluorescence-Guided Surgery, Lymphadenectomy, Lymph Node Yield, Adequacy of Lymphadenectomy, Minimally Invasive Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 4 Nov 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.
This prospective, single-center, non-randomized study with a historical control group evaluated the clinical utility of indocyanine green-guided lymphatic mapping (ICG-LM) during minimally invasive surgery for sigmoid colon and rectal cancer.
Adequate lymph node removal is an essential component of colorectal cancer surgery, as the number of lymph nodes examined influences the accuracy of pathological staging and subsequent treatment decisions. Current oncological recommendations generally support the examination of at least 12 lymph nodes for adequate nodal assessment.
Indocyanine green is a fluorescent dye that enables visualization of lymphatic drainage pathways using near-infrared imaging. Fluorescence-guided lymphatic mapping may help surgeons identify lymphatic structures and lymph nodes that are not readily visible under conventional imaging.
Patients prospectively enrolled in the intervention group underwent endoscopic submucosal injection of ICG before minimally invasive oncological resection. Intraoperative near-infrared fluorescence imaging was used to visualize lymphatic drainage and guide lymph node identification. Outcomes were compared with those of a historical control group of patients who had undergone standard minimally invasive surgery without fluorescence-guided lymphatic mapping.
The primary outcome was the adequacy of lymphadenectomy, evaluated by the proportion of patients with fewer than 12 lymph nodes retrieved and identified during histopathological examination.
Additional outcomes included the total number of retrieved lymph nodes, metastatic lymph node yield, operative time, and postoperative outcomes.
Propensity score matching and overlap weighting were used to account for differences in baseline characteristics between the intervention and historical control groups.
The study assessed the potential value of ICG-guided lymphatic mapping for improving lymph node assessment during minimally invasive surgery for sigmoid colon and rectal cancer.
Detailed description
Background and Rationale
Adequate lymphadenectomy is a fundamental component of curative-intent surgery for colorectal cancer. Accurate pathological assessment of regional lymph nodes is essential for determining disease stage, guiding adjuvant treatment, and estimating prognosis. Retrieval and examination of at least 12 lymph nodes is widely accepted as a benchmark for adequate nodal staging.
Nevertheless, lymph node yield may vary according to patient characteristics, tumor location, previous neoadjuvant treatment, surgical technique, and pathological assessment.
Indocyanine green-guided lymphatic mapping (ICG-LM) is a fluorescence-guided surgical technique that enables visualization of lymphatic drainage pathways using near-infrared imaging. By identifying fluorescent lymphatic structures and lymph nodes, this approach may improve intraoperative recognition of lymphatic drainage patterns and facilitate lymph node retrieval.
Study Design and Population
This was a prospective, single-center, non-randomized comparative study with a historical control group, conducted at the University Hospital in Krakow, Poland.
The study included patients undergoing minimally invasive oncological resection for sigmoid colon or rectal adenocarcinoma.
The intervention group consisted of prospectively enrolled patients who underwent indocyanine green-guided lymphatic mapping during minimally invasive colorectal cancer surgery.
The historical control group consisted of patients who had previously undergone standard minimally invasive oncological resection without ICG-guided lymphatic mapping. Clinical and perioperative data from the historical cohort were used for comparative analysis.
No random allocation was performed.
ICG Administration and Fluorescence-Guided Surgery
Patients in the intervention group underwent intraoperative endoscopic administration of indocyanine green into the submucosal layer surrounding the tumor.
The administered dose was 2.5 mg of ICG, corresponding to 2 mL of a solution with a concentration of 1.25 mg/mL.
During minimally invasive surgery, near-infrared fluorescence imaging was used to visualize lymphatic drainage pathways and fluorescent lymph nodes.
Standard oncological resection and lymphadenectomy were performed according to established surgical principles. Fluorescence imaging served as an adjunct to conventional anatomical dissection rather than a replacement for standard oncological surgery.
The fluorescence-guided technique allowed the surgical team to assess lymphatic drainage patterns and identify potentially relevant lymph nodes.
Study Outcomes
The principal outcome of the comparative analysis was the adequacy of lymphadenectomy, assessed by the proportion of patients with an inadequate lymph node yield, defined as fewer than 12 lymph nodes retrieved and identified during histopathological examination of the surgical specimen.
Additional outcomes included total lymph node yield, the number of metastatic lymph nodes, operative time, and postoperative outcomes, including complications and recovery parameters.
The study also evaluated the technical feasibility of fluorescence-guided lymphatic mapping and the intraoperative visualization of lymphatic drainage pathways.
Statistical Analysis
Because treatment allocation was not randomized and the control group was historical, propensity score-based methods were applied to reduce the influence of differences in baseline patient characteristics.
Propensity score matching (PSM) was performed to construct comparable groups based on relevant demographic and clinical characteristics.
The primary outcome was evaluated by comparing the proportion of patients with fewer than 12 retrieved lymph nodes between the ICG-LM and control groups. Effect estimates were expressed using appropriate measures of association and 95% confidence intervals.
An additional analysis using propensity score overlap weighting was performed to assess the robustness of the findings and improve comparability between treatment groups.
Secondary outcomes were compared using statistical methods appropriate to the type and distribution of each variable.
Study Significance
This study investigated the clinical utility of indocyanine green-guided lymphatic mapping in minimally invasive oncological surgery for sigmoid colon and rectal cancer.
By comparing prospectively enrolled patients undergoing fluorescence-guided surgery with a historical control cohort, the study sought to provide preliminary evidence regarding the relationship between fluorescence-guided lymphatic mapping, adequacy of lymphadenectomy, and perioperative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative ICG-Guided Lymphatic Mapping | Experimental | Procedure: Intraoperative ICG-Guided Lymphatic MappingPatients with sigmoid colon or rectal cancer undergoing minimally invasive oncological resection with intraoperative indocyanine green (ICG)-guided lymphatic mapping. ICG was administered intraoperatively at a total dose of 2.5 mg, corresponding to 2 mL of a solution with a concentration of 1.25 mg/mL. Near-infrared fluorescence imaging was used to visualize lymphatic drainage pathways and identify fluorescent lymph nodes, including those outside the expected lymphatic drainage territory. Fluorescence findings were used to guide intraoperative assessment of lymphatic drainage and identify potential aberrant drainage pathways. |
| Historical Control Group - Standard Surgery | No intervention | –Patients with sigmoid colon or rectal cancer who underwent minimally invasive oncological resection without indocyanine green (ICG)-guided lymphatic mapping. This historical control group consisted of patients treated at the same institution before implementation of the ICG lymphatic mapping protocol. All patients underwent standard oncological resection with lymphadenectomy according to established surgical principles. No ICG was administered for lymphatic mapping, and no fluorescence-guided lymph node identification was performed. Data were collected retrospectively from institutional medical records for comparison with the prospectively enrolled ICG-LM group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Histologically confirmed or clinically suspected primary adenocarcinoma of the sigmoid colon or rectum.
- Resectable disease (cT1-T4b, N0-3, M0), according to the AJCC TNM classification, 8th edition.
- Eligibility for curative-intent minimally invasive surgical resection (laparoscopic or robotic), either as initial treatment or following neoadjuvant therapy.
Key exclusion criteria (7 listed)
- Unresectable distant metastases identified on preoperative imaging.
- Pregnancy or breastfeeding.
- Known allergy to iodine-containing compounds or previous adverse reactions to indocyanine green (ICG).
- Intraoperative identification of unresectable metastatic disease.
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative ICG-Guided Lymphatic MappingIntraoperative lymphatic mapping using indocyanine green (ICG) during minimally invasive oncological resection for sigmoid colon or rectal cancer. Under general anesthesia, before surgical resection, ICG was administered endoscopically into the submucosal layer around the tumor using a 23-gauge injection needle introduced through the working channel of a flexible endoscope. A total of 2.5 mg of ICG (2 mL of a 1.25 mg/mL solution) was injected at four peritumoral sites (0.5 mL per site). After completion of standard oncological resection, near-infrared fluorescence imaging was used to visualize lymphatic drainage and identify fluorescent lymph nodes outside the standard dissection field. These additional lymph nodes were removed separately for histopathological examination. | Procedure or surgery | Intraoperative ICG-Guided Lymphatic Mapping |
Primary outcome
Proportion of Patients With Inadequate Lymphadenectomy
Time frame: From surgery to final histopathological assessment (approximately 30 days after surgery).
The proportion of patients with inadequate lymphadenectomy, defined as retrieval of fewer than 12 lymph nodes in the surgical specimen, as determined by final histopathological examination. This outcome will be compared between patients undergoing minimally invasive colorectal cancer surgery with intraoperative indocyanine green-guided lymphatic mapping (ICG-LM) and a historical control group undergoing standard minimally invasive surgery without ICG-LM.
9 secondary outcomes
Total Number of Retrieved Lymph Nodes
Time frame: From surgery to final histopathological assessment (approximately 30 days after surgery).
Successful Lymphatic Mapping Rate
Time frame: Intraoperatively, during the index surgical procedure.
Aberrant Lymphatic Drainage Rate
Time frame: Intraoperatively, during the index surgical procedure.
Number of Additional Lymph Nodes Identified Through ICG Mapping
Time frame: From surgery to final histopathological assessment (approximately 30 days after surgery).
Postoperative Complications
Time frame: Within 30 days after surgery.
Length of Postoperative Hospital Stay
Time frame: From the date of surgery to hospital discharge (length of postoperative hospital stay, measured in days, on average, less than 30 days).
Hospital Readmission Within 30 Days
Time frame: Within 30 days after surgery.
30-Day Mortality
Time frame: Within 30 days after surgery.
Reoperation Within 30 Days
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to patient confidentiality and data protection considerations.
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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?
A study testing Intraoperative ICG-Guided Lymphatic Mapping in people with Rectal Cancer and Sigmoid Colon Cancer, 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 7 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 Nov 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?
Proportion of Patients With Inadequate Lymphadenectomy (time frame: From surgery to final histopathological assessment (approximately 30 days after surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.