Clinical trial · Interventional
Combined Endoscopic and Laparoscopic Surgery (CELS) for Early Colon Cancer in High Risk Patients
NCT04606992CI-TRIAL-00060357completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a pilot feasibility study on high risk patients due to frailty and comorbidity who have early stage colon cancer (UICC 1). We will use a novel resection technique with expected less risk of complications called the Combined Endoscopic and Laparoscopic Surgery (CELS). After the histopathologic evaluation. Patients will be placed in either low risk or high risk group. Depending on this, they will be followed for 3 years or referred to standard resection
Conditions
Conditions (1)
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 Cancer Stage I | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CELS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CELS resection
- description
- All patients included in the study will be in this arm
- interventionNames
- Procedure: CELS
Primary outcomes (1)
- measure
- Resection margin
- timeFrame
- 1 month
- description
- R0, R1, R2
Secondary outcomes (1)
- measure
- Complication rate
- timeFrame
- 1 month
- description
- 30 day complication using clavian dindo grading
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * UICC stage 1 colon cancer * ASA score min. 3 and/or WHO PS score min. 1 * CELS eligible resection * Biopsy show adenocarcinoma or suspicious lesion * No preop chemo or radiotherapy * Accept inclusion Exclusion Criteria: * Hereditary cancer * Rectal cancer * Radiation downstaging
References
Publications (0)
Data not yet available
No reference posted for this study.