ESD Versus TAMIS for Early Rectal Neoplasms (NCT03217773) | Clinical Trial Compass
UnknownNot Applicable
ESD Versus TAMIS for Early Rectal Neoplasms
Hong Kong114 participantsStarted 2017-07-01
Plain-language summary
This is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients diagnosed with nonpedunculated early rectal neoplasms \>/= 2 cm in size in the rectum (\>/= 3 cm and \</= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or EMR as judged by two experienced endoscopist
* Age of patients \>18 years;
* American Society of Anesthesiologists (ASA) grading I-III
* Informed consent available
Exclusion Criteria:
* Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB)
* Evidence of deep invasion on endorectal ultrasonography
* Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion)
* Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection
* Patients with recurrence from previous Endoscopic Mucosal Resection or ESD
* Patients with known metastatic disease
* Patients with non-correctable coagulopathy