Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Recruiting
N/A
Interventional Study
Colon Cancer
Colon Adenocarcinoma
Sentinel Lymph Node
Sentinel Lymph Node Biopsy
Colon Neoplasms
Colon Neoplasm
Fluorescence
Fluorescence Guided Surgery
Fluorescence Laparoscopy
Fluorescence-guided Resection
Colon Surgery
Indocyanine Green (ICG)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 341 (estimated)
- Sponsor
- Meander Medical Center · Other
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About This Trial
The aim of this study is to reduce the need for colectomy and its' associated morbidity and mortality in patients with pT1-2 colon carcinoma after endoscopic resection and an estimated lymph node metastasis (LNM) risk of \>15%, or with macroscopically suspected T1 tumors, by performing an endoscopic-assisted laparoscopic/robotic wedge resection of the tumor or scar, along with sentinel node (SLN) …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Oral and written informed consent (IC)
* Aged 18 years and older
* Fit for both organ-sparing surgery and colectomy
* Pathologically confirmed T1-2 adenocarcinoma of the colon following R0, R1, or Rx endoscopic resection with an estimated LNM risk \>15% (Table 5.2.2. in module…
Contacts