NCT07916532Completed
Indocyanine Green Lymphatic Mapping in Minimally Invasive Sigmoid and Rectal Cancer Surgery
Indocyanine Green Lymph Node Mapping During Minimally Invasive Rectosigmoid Cancer Surgery: A Prospective Single-Center Study
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 27 Oct 2026
- Start date
- 8 Oct 2023
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Jagiellonian University
- Diseases
- Colorectal cancer
- NCT number
- NCT07916532
What you commit to
- Study type: Interventional
- Participants enrolled: 29
- From 8 Oct 2023 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known allergy to iodine-containing compounds or previous adverse reactions to indocyanine green (ICG).
- Intraoperative Exclusion Criteria:
- Conversion to open surgery.
Other illness
- Intraoperative identification of unresectable metastatic disease.
Other
- Unresectable distant metastases identified on preoperative imaging.
- Pregnancy or breastfeeding.
- Final histopathological diagnosis inconsistent with adenocarcinoma.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital in Krakow (Szpital Uniwersytecki w Krakowie) Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.