NL-OMON22704
Recruiting
Not Applicable
Ong-term onCologicAL outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC
Amsterdam University Medical Center, location AMC0 sites153 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- endoscopic full thickness resectioncolorectal polypT1 colorectal cancercolonoscopy
- Sponsor
- Amsterdam University Medical Center, location AMC
- Enrollment
- 153
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients meeting all of the following criteria will be invited for participation in the study:
- •\-Recent polypectomy/(p)EMR/ESD of T1 CRC without the following histological high\-risk features\*:
- •oPoor differentiation
- •oLymphovascular invasion (NB if lymphovascular invasion cannot be assessed, patients are NOT eligible for inclusion)
- •oTumor budding grade 2/3 (NB if tumor budding cannot be assessed at histopathology, patients are NOT eligible for inclusion)
- •\-This recent polypectomy/(p)EMR/ESD for T1 CRC resulted in positive resection margins \< 0\.1mm (R1\) or indeterminate resection margins (Rx)
- •\-The resection scar after polypectomy/EMR/ESD is clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colonic segment where no other polypectomies were performed
- •\-The diameter of the original lesion was \= 30 mm
- •\-The diameter of the scar and/or residual lesion \= 15 mm
- •\-The interval between index polypectomy/EMR and additional eFTR is at most 12 weeks
Exclusion Criteria
- •Patients meeting any of the following criteria will be excluded from participation in this study:
- •\-If lymphovascular invasion and/or tumor budding grade 2/3 cannot be assessed after prior polypectomy/(p)EMR, patients are NOT eligible for inclusion
- •\-The patient is known with at least one of the following conditions:
- •oActive inflammatory bowel disease (IBD) in the colon
- •oSynchronous advanced CRC (defined as CRC in the 5 years before detection of T1 CRC, or elsewhere in the colorectum at the time of detection of T1 CRC)
- •\-Index lesion located \< 5 cm of the anal verge or with involvement of the valvula Bauhini or appendiceal orifice
- •\-Age \< 18 years
- •\-Pregnancy
Outcomes
Primary Outcomes
Not specified
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