Clinical trial: SCar-biopsies After Malignant Colorectal Polypectomy of Uncertain RAdicality (NCT02328664)

Eligibility criteria:
Inclusion Criteria:

          -  Aged 18 or above.

          -  Endoscopically removed colorectal lesion with the following pathological
             characteristics:

               -  A moderately-to-well differentiated adenocarcinoma.

               -  If possible to judge: distance between adenocarcinoma and vertical or lateral
                  resection margin is less than 1 mm.

               -  In case of piecemeal resection: unjudgeable radicality (mostly due to loss of
                  orientation and multiple fragments).

               -  Absence of / unjudgeable lymphatic / vascular invasion.

               -  No or only grade I tumor budding.

          -  No suspicion of dissemination on the following investigations: serum carcino-embryonic
             antigen, a 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): an additional magnetic resonance
             imaging of the rectum.

          -  Operation is advised in agreement with the Dutch Guideline on Colorectal cancer,
             planned and agreed on by the patient.

          -  Written informed consent is obtained.

        Exclusion Criteria:

          -  Pathology shows one or more of the following characteristics:

               -  A radical en-bloc resection with a free vertical and lateral margin of ≧ 1 mm.

               -  A poorly differentiated or signet-cell containing adenocarcinoma.

               -  Lymphatic or vascular invasion (if this feature is unjudgeable due to piecemeal
                  resection, no exclusion is done).

               -  Tumor budding grade II-III.

          -  Suspicion of dissemination on investigations as mentioned in the inclusion criteria.

          -  Patients already receiving anti-tumor treatment for another tumor or a synchronic
             colorectal cancer.

          -  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. Such at the
             decision of the patient and / or treating physician.

          -  Patient is planned for trans-anal surgery.

          -  Patient is not planned for surgery.

          -  Patient is pregnant.

          -  Patient does not provide written informed consent or is unable to provide such.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Contradiction