Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy

Rectal Cancer Clinical Trial

— (GreenEye-CRC)  

Official title:

Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873621
• Other study ID #: 279/20
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2023
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Luca Sorrentino, MD
• Phone: +39 0223902578
• Email: luca.sorrentino[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Cancer Metastatic
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• ICG-guided lymphadenectomy
Excision of ICG-fluorescent lymph nodes in addition to standard laparoscopic total mesorectal excision in rectal cancer patients after neoadjuvant chemoradiation

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Colletti 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of harvested lymph nodes		15 days
Primary	Number of harvested extra-mesorectal lymph nodes		15 days
Secondary	Intraoperative and postoperative complications rates		15 days
Secondary	Time of surgery		15 days