ICG in Colon Cancer

Official title

A Prospective Study of Indocyanine Green (ICG) Fluorescence-Guided Lymphatic Mapping During Laparoscopic Colon Cancer Resection

Overview

The aim of this study is to evaluate the role of indocyanine green (ICG) injection in fluorescence-guided lymphatic mapping during laparoscopic colon cancer resection. This is a single-center prospective single-arm pilot clinical study that will include at least 25 patients with resectable colon cancer. All enrolled patients will undergo intraoperative subserosal ICG-guided lymphatic mapping before dissection, and intravenous ICG perfusion assessment before anastomosis. The primary goal is to determine the proportion of analyzable pN+ patients in whom all metastatic lymph nodes identified on final histopathology are located within the ICG-mapped lymphatic basin.

Detailed description

Adequate lymphadenectomy is a key component of curative colon cancer surgery because lymph node status is essential for accurate staging and postoperative treatment planning. Indocyanine green (ICG) fluorescence imaging has become increasingly used intraoperatively to make otherwise invisible lymphatic pathways visible in real time.

Preoperative and Perioperative Care:

All patients will undergo standard preoperative evaluation including colonoscopy with biopsy confirmation, baseline laboratory investigations, carcinoembryonic antigen measurement, and contrast-enhanced CT staging. Perioperative care will follow an enhanced recovery pathway including counseling, thromboembolism prophylaxis, antibiotic prophylaxis, multimodal analgesia, early mobilization, and early oral intake.

Operative Protocol:

Laparoscopic oncologic colectomy will be performed according to tumor location. Fluorescence imaging will be performed using the KARL STORZ IMAGE1 STM Rubina platform. Indocyanine green will be injected subserosally around the tumor in four quadrants whenever feasible. Near-infrared imaging will then be used to identify lymphatic channels and nodal basins before definitive mesenteric division. Any fluorescence-related modification of the extent of mesenteric excision or pedicle clearance will be recorded prospectively. Before bowel anastomosis, intravenous indocyanine green will be used to assess perfusion of the bowel ends by near-infrared fluorescence imaging.

Pathology and Follow-up:

The mapped area will be identified on the specimen by sutures or clips or separately labeled packets, allowing the pathologist to record metastatic lymph nodes as located within or outside the ICG-mapped basin. Patients will be followed during hospital admission and for 3, 6, and 9 months after surgery to record postoperative complications, final histopathological outcomes, and morbidity according to the Clavien-Dindo classification

Interventions

• Drug Indocyanine green (ICG) injection for intraoperative lymph node imaging
  Indocyanine green is injected subserosally around the tumor in four quadrants for lymphatic mapping. Additionally, intravenous ICG is administered before bowel anastomosis to assess perfusion of the bowel ends using near-infrared fluorescence imaging.
• Procedure Laparoscopic Colon Cancer Resection
  Standard laparoscopic colectomy with oncologic lymphadenectomy performed according to institutional practice.

Primary outcome measures

• Proportion of analyzable pN+ patients with all metastatic lymph nodes located within the ICG-mapped lymphatic basin [Time frame: Up to 2 weeks postoperatively (upon completion of final histopathology report)]

Secondary outcome measures (6)

• Successful intraoperative visualization of lymphatic drainage (Feasibility rate) [Time frame: Intraoperative]
• Frequency of fluorescence-guided modification of mesenteric excision [Time frame: Intraoperative]
• Change in the planned transection line due to perfusion assessment [Time frame: Intraoperative]
• Metastatic lymph nodes identified outside conventional resection margins [Time frame: Up to 2 weeks postoperatively (upon completion of final histopathology report)]
• Total Lymph nodal yield [Time frame: Up to 2 weeks postoperatively (upon completion of final histopathology report)]
• Postoperative Morbidity and Mortality [Time frame: Baseline, postoperative day 30, and at 3, 6, and 9 months after surgery]

Eligibility criteria

Inclusion criteria

Age >= 18 years.

\- Histologically confirmed colon adenocarcinoma.

Exclusion criteria

• Emergency surgery (obstruction/perforation with sepsis) requiring urgent operation.
• Known allergy or contraindication to ICG (including prior anaphylaxis to ICG; severe hypersensitivity history per anesthesia assessment).
• Pregnancy or breastfeeding.
• Severe hepatic failure (because ICG clearance is hepatobiliary) or other contraindication determined by anesthesia team.
• Planned palliative resection only.
• ASA physical status IV or patients otherwise deemed unfit for elective curative colectomy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Galema HA, Meijer RPJ, Lauwerends LJ, Verhoef C, Burggraaf J, Vahrmeijer AL, Hutteman M, Keereweer S, Hilling DE. Fluorescence-guided surgery in colorectal cancer; A review on clinical results and future perspectives. Eur J Surg Oncol. 2022 Apr;48(4):810-821. doi: 10.1016/j.ejso.2021.10.005. Epub 2021 Oct 9. PMID 34657780
• Wexner S, Abu-Gazala M, Boni L, Buxey K, Cahill R, Carus T, Chadi S, Chand M, Cunningham C, Emile SH, Fingerhut A, Foo CC, Hompes R, Ioannidis A, Keller DS, Knol J, Lacy A, de Lacy FB, Liberale G, Martz J, Mizrahi I, Montroni I, Mortensen N, Rafferty JF, Rickles AS, Ris F, Safar B, Sherwinter D, Sileri P, Stamos M, Starker P, Van den Bos J, Watanabe J, Wolf JH, Yellinek S, Zmora O, White KP, Dip F PMID 36427929
• Cassinotti E, Al-Taher M, Antoniou SA, Arezzo A, Baldari L, Boni L, Bonino MA, Bouvy ND, Brodie R, Carus T, Chand M, Diana M, Eussen MMM, Francis N, Guida A, Gontero P, Haney CM, Jansen M, Mintz Y, Morales-Conde S, Muller-Stich BP, Nakajima K, Nickel F, Oderda M, Parise P, Rosati R, Schijven MP, Silecchia G, Soares AS, Urakawa S, Vettoretto N. European Association for Endoscopic Surgery (EAES) con PMID 36781468

Identifiers

NCT: NCT07638956 · 36265MD41060/4/26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗