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Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma

ConditionsColon CancerColon AdenocarcinomaSentinel Lymph NodeSentinel Lymph Node BiopsyColon NeoplasmsColon NeoplasmFluorescenceFluorescence Guided SurgeryFluorescence LaparoscopyFluorescence-guided ResectionColon SurgeryIndocyanine Green (ICG)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMeander Medical Center

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) biopsy using indocyanine green (ICG). This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design. The primary outcome is the 3-year recurrence rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 5.2 of the Dutch CRC guideline); 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 MDT

Disqualifiers

Patients who opt for active follow-up instead of surgery following shared decision-making

Distant metastasis

Lynch syndrome

Another active malignancy requiring palliative treatment at the time of colon cancer diagnosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Organ-sparing surgery

    Procedure/Surgery

    Endoscopy-assisted laparoscopic/robotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.

  • Standard of care segmental resection

    Procedure/Surgery

    Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.

Treatment groups

341 Participants
are divided into 2 treatment groups
Group A: Organ-sparing surgeryExperimental treatment 1 intervention
Group B: Standard of care segmental resectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3-year recurrence rate

Time frame
3 years postoperatively
2

Successful sentinel lymph node biopsy

Percentage of patients undergoing a successful sentinel lymph node biopsy with one or more sentinel lymph nodes detected

Time frame
Intraoperative

Secondary outcomes

1

5-year recurrence rate

Time frame
5 years postoperatively
2

3-year overall survival

Time frame
3 years postoperatively
3

5-year overall survival

Time frame
5 years after postoperatively
4

90-days complication rate

Clavien-Dindo classification

Time frame
90 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meander Medical Center

Lead sponsor

Source ClinicalTrials.gov
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