Large bowel cancer
Conditions
Interventions
Sponsors
Deventer Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of second-look biopsies from the polypectomy site for residual tumor in the resected bowel. Sensitivity is determined by the number of tumor-positive biopsies divided by the number of tumor positive resection specimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| * 90-day mortality after rescue surgery: the number of patients that died within 91 day after the operation for presumed residual adenocarcinoma* * The sensitivity of biopsies for residual cancer in the bowel wall: the number of patients with endoscopic biopsies containing adenocarcinoma divided by the number of patients with adenocarcinoma in the resected bowel wall (regardless of regional lymph nodes)* * The number of complications (defined according to GCP) after biopsies from the polypectomy: the number of patients with bleeding or perforation after taking biopsies from the polypectomy scar, requiring at least prolongation of treatment, or admission to hospital, or delay or speeding up rescue surgery. This up until the moment of surgery. * The sensitivity of global endoscopic assessment of initial polypectomy as well as scar biopsies for residual cancer: the number of patients in whom the endoscopic resection was assessed as incomplete and who also have residual cancer in the surgically resected specimen divided by the total number of patients in whom the endoscopic resection was judged to be incomplete. * The proportion of patients with residual cancer in the resected specimen if malignancy was unsuspected during the endoscopic polypectomy: the number of patients in whom the malignancy was initially unsuspected during endoscopic polypectomy and who also have residual cancer in the surgical specimen divided by the total number of patients in whom the malignancy was initially unsuspected during endoscopic polypectomy. * The prevalence of residual tumor at operation and postoperative morbidity and mortality in patients in whom exclusion criteria are applicable, and there for are not eligible for taking biopsies. | — |
Countries
The Netherlands
Outcome results
None listed