Clinical trial · Interventional
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled 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)
Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery. Co-primary endpoints are * Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment * CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Treatment Side Effects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor removal | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- Patients randomized to surgery are treated according to current guidelines with either open, laparoscopic or robotic surgical segmental bowel resection corresponding to lymphovascular drainage of the cancer.
- interventionNames
- Procedure: Tumor removal
- type
- EXPERIMENTAL
- label
- EFTR (Endoscopic Full-Thickness Resection)
- description
- Patients randomised to EFTR are treated using devices approved for eFTR in the European Union and affiliated countries for the indication as applied in the trial. Before EFTR, the scar is identified and documented. The colonoscope is then removed, the EFTR device mounted, the colonoscope re-introduced, and eFTR performed.
- interventionNames
- Procedure: Tumor removal
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin \<0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge)) * No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre * Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B3. * No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation * Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment * No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization * Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve. * No colonic strictures or severe diverticulosis. * No prior CRC * No other malignant disease which is not deemed cured * No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome) * No inflammatory bowel disease * Written informed consent provided by before enrolment Exclusion Criteria: * all who do not fulfill inclusion criteria
References
Publications (0)
Data not yet available