Clinical trial · Interventional
Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The main questions it aims to answer are: * Does the use of ICG increase the total number of harvested lymph nodes? * Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes? Participants will intraoperatively receive a trans-anal administration of ICG near to rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. A comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of ICG.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Cancer Metastatic | Rectal Neoplasm | PROBABILISTIC | 0.70 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG-guided lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG-guided lymphadenectomy
- description
- Patients will intraoperatively receive a transanal local administration of ICG. During laparoscopic total mesorectal excision, ICG-fluorescent lymph nodes beyond the mesorectum will be separately excised and sent for pathology
- interventionNames
- Procedure: ICG-guided lymphadenectomy
Primary outcomes (2)
- measure
- Total number of harvested lymph nodes
- timeFrame
- 15 days
- measure
- Number of harvested extra-mesorectal lymph nodes
- timeFrame
- 15 days
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Low or middle rectal adenocarcinoma * Indication for sphincter-saving surgery * Neoadjuvant chemoradiation * Indication for laparoscopic surgery * Signed informed consent Exclusion Criteria: * Distant metastases at diagnosis, included peritoneal carcinomatosis * Squamous cell cancer * Allergy to indocyanine green
References
Publications (1)
- BACKGROUNDColletti G, Battaglia L, Sorrentino L, Guaglio M, Cosimelli M. Indocyanine green-guided lymphadenectomy of the inferior mesenteric artery in laparoscopic total mesorectal excision for low rectal cancer after neoadjuvant chemoradiotherapy - A Video Vignette. Colorectal Dis. 2022 Apr;24(4):547. doi: 10.1111/codi.16031. Epub 2022 Jan 6. No abstract available. PMID 34953173