Clinical trial · Interventional
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenocarcinoma | Colon Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Neoplasms | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colon Surgery | — | UNRESOLVED | — |
| Fluorescence | — | UNRESOLVED | — |
| Fluorescence-guided Resection | — | UNRESOLVED | — |
| Fluorescence Guided Surgery | — | UNRESOLVED | — |
| Fluorescence Laparoscopy | — | UNRESOLVED | — |
| Indocyanine Green (ICG) | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Organ-sparing surgery | Procedure | — | UNRESOLVED |
| Standard of care segmental resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Organ-sparing surgery
- description
- Local resection with sentinel lymph node biopsy
- interventionNames
- Procedure: Organ-sparing surgery
- type
- ACTIVE_COMPARATOR
- label
- Standard of care segmental resection
- interventionNames
- Procedure: Standard of care segmental resection
Primary outcomes (2)
- measure
- 3-year recurrence rate
- timeFrame
- 3 years postoperatively
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 * The 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 performed * Lesion located \>25cm from the anus based on endoscopic measurement, or above sigmoid take-off Exclusion Criteria: * 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 * Previous colorectal cancer within the last 5 years * Tumours that comprised \>50% of the colon circumference before resection * Tumours involving the ileocaecal valve * Pregnancy, lactation or a planned pregnancy during the course of the study * Known 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 surgery * Severe kidney- or liver failure * Hyperthyroidism or an autonomously functioning thyroid adenoma
References
Publications (0)
Data not yet available