The sensitivity of scar-biopsies for residual colorectal adenocarcinoma after endoscopic resection with uncertain radicality.

Completed

• Conditions: Large bowel cancer; 10017990

• Registration Number: NL-OMON44110
• Lead Sponsor: Deventer Ziekenhuis

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-02-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 103

Inclusion Criteria

All of the following criteria should be fulfilled:;1. Age 18 or above.
2. Endoscopically removed colorectal lesion with the following pathological characteristics:
a. A moderately to well-differentiated adenocarcinoma.
b. In case of an en-bloc resection: distance between adenocarcinoma and vertical or lateral resection
margin is less than 1 mm.
c. In case of piecemeal resection: unjudgeable radicality (mostly due to loss of orientation and multiple
fragments).
d. Absence of, or unjudgeable lymphatic or vascular invasion.
e. No tumor budding (only if specifically mentioned in the pathology report).
f. No deep (> 1mm) submucosal infiltration.
3. No suspicion of dissemination on the following investigations: serum carcino-embryonic antigen,
computer tomographic (CT) scan of the abdomen and a chest X-ray; in case of a rectal tumor (less
than 15 cm from the anal verge): magnetic resonance imaging of the rectum.
4. Operation (including local transmural excision by TEM, TAMIS or eFTR*) is advised in agreement
with the Dutch Guideline on Colorectal cancer and has been planned and agreed on by the
patient.
5. Written informed consent is obtained.;*TEM: Transanal Endoscopic Microsurgical excision
TAMIS: TransAnal Minimal Invasive Surgery
eFTR: Endoscopic Full-Thickness Resection

Exclusion Criteria

1. Pathology shows one or more of the following characteristics:
a. A radical en-bloc resection with a free vertical and lateral margin of * 1 mm.
b. A poorly differentiated or signet-cell containing adenocarcinoma.
c. Lymphatic or vascular invasion (if this feature is unjudgeable due to piecemeal resection, no
exclusion is done).
d.Tumor budding (only if specifically mentioned in the pathology report)
f. Deep (> 1 mm) submucosal infiltration
2. Suspicion of dissemination on investigations as mentioned in the inclusion criteria
3. Patients already receiving anti-tumor treatment (including radiotherapy for rectal cancer) for another tumor or a synchronic colorectal cancer
4. Patients in whom a second-look endoscopy would require major and unacceptable effort and / or
resources, for instance clinical admission for bowel preparation, long travel, general anesthesia,
extremely difficult to reach polypectomy site.
5. Patient is not planned for endoluminal local resection (TEM, TAMIS, eFTR)*, or standard surgery.
6. Patient is pregnant.
7. Patient does not provide written informed consent or is unable to provide such.;*TEM: Transanal Endoscopic Microsurgical excision
TAMIS: TransAnal Minimal Invasive Surgery
eFTR: Endoscopic Full-Thickness Resection

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity of second-look biopsies from the polypectomy site for residual<br /><br>tumor in the resected bowel. Sensitivity is determined by the number of<br /><br>tumor-positive biopsies divided by the number of tumor positive resection<br /><br>specimens.</p><br>