An interventional study of Intraoperative ICG-Guided Lymphatic Mapping in Rectal Cancer and Sigmoid Colon Cancer, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Jagiellonian University · Not applicable, Interventional, and Treatment
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.
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.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's enrollment of 29 is below the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Intraoperative Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Intraoperative ICG-Guided Lymphatic Mapping
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.
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.
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.
Time frame: From surgery to final histopathological assessment (approximately 30 days after surgery).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
The proportion of patients requiring unplanned hospital readmission within 30 days after the index surgical procedure.
Time frame: 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.
Time frame: 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.
Time frame: Within 30 days after surgery.
Plan to share: No — Individual participant data will not be made publicly available due to patient confidentiality and data protection considerations.
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