colon cancer colon carcinoma
Conditions
Interventions
1. Patients are identified at the outpatient clinic after multidisciplinary 
consultation and asked for participation in the study.
2. Patients will be planned for endoscopic-assisted wedge resection.
3. Mechanical bowel preparation (MBP) will take place one day prior to surge
colonoscopy will be performed. Subsequently the gastroenterologist will create 
four blebs around the tumour with 0.9% NaCl. Thereafter, the gastroenterologist 
will inject ICG in the four blebs in order to minimise spill of ICG. 
5. The available near-infrared camera system is used to visualise the SLN, 
which will be harvested. If multiple SLNs appear, the first four SLNs will be 
harvested.
Wedge resection
6. A suture is placed with intraluminal endoscopic visualisation at the base of 
scar of the tumour.
7. Traction is given on the suture to enable positioning of a linear stapler. 
8. The patency of the colonic lumen and total inclusion of the tumour/scar is checked 
by the gastroenterologist before stapling. 
9. After stapling, the resected specimen is removed in an endobag after which 
the gastroenterologist and surgeon check the colon for signs of bleeding or 
perforation before ending the procedure. 
An instructional video of wedge resection is available at www.limeric.nl
Postoperative procedures
10. Postoperative care on the ward will be according to SOC. 
11. Pathological examination will be done using haematoxylin &
eosin (H&
E). If 
the SLN is negative, the SLN will be examined using serial slicing and&
Sponsors
Meander Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Oral and written informed consent (IC)Aged 18 years and olderFit for both organ-sparing surgery and colectomyPathologically confirmed T1–2 adenocarcinoma of the colon following R0, R1, or Rx endoscopic resection with an estimated LNM risk >15%; or a lesion macroscopically suspected to be (deep-invasive) T1 colon cancer, measuring <40 mm, for which wedge resection is considered the most suitable local resection technique as recommended by the MDTThe resection scar after local excision is expected to be clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colorectal segment where no other polypectomies were performedLesion located >25cm from the anus based on endoscopic measurement, or above sigmoid take-offThe estimated LNM risks for pT1-2 colorectal carcinoma are defined in Table 1 (protocol) and Table 5.2.2. in module 5.2 of the Dutch CRC guideline.
Exclusion criteria
Exclusion criteria: Patients who opt for active follow-up instead of surgery following shared decision-makingDistant metastasisLynch syndromeAnother active malignancy requiring palliative treatment at the time of colon cancer diagnosisPrevious colorectal cancer within the last 5 yearsTumours that comprised >50% of the colon circumference before resectionTumours involving the ileocaecal valvePregnancy, lactation or a planned pregnancy during the course of the studyKnown allergy to any of the compounds used for SLN identification (ICG, Iodine or Sodium iodide)Previous colonic surgery (excluding appendectomy)Contra-indication for laparoscopic or robotic surgerySevere kidney- or liver failureHyperthyroidism or an autonomously functioning thyroid adenoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of phase II is percentage of successful wedge resections and SLN biopsies. The primary outcome of phase III is 3-year proportion of recurrences (recurrence at the site of the excised primary cancer or the adjacent mesocolon, lymph node metastases or distant metastases) in which wedge resection and SLN biopsy will be compared to standard segmental resection. The 3-year (locoregional) recurrence was chosen as the primary outcome since 92% of recurrences occur during this time period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: - Proportion of patients with preference for standard and experimental treatment, and without preference - Procedure time of organ-sparing surgery vs segmental resection - Intraoperative complications - Percentage of patients with a positive SLN Phase III: - 90-days postoperative morbidity (Clavien-Dindo classification) - 90-days postoperative mortality - 5-year proportion of recurrences - 3-year overall survival - 5-year overall survival - Quality of life - Costs - Upstaging of SLNs due to ultrastaging | — |
Countries
Netherlands
Contacts
Public ContactB.C.T. Laar
Meander Medisch Centrum
Outcome results
None listed