Endoscopic Submucosal Dissection (ESD) Versus Transanal Minimally Invasive Surgery (TAMIS) for Early Rectal Neoplasms: a Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Short-term morbidity
Study Overview
Brief 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.
Detailed Description
Background: Transanal minimally invasive surgery (TAMIS) is an effective surgical alternative to transanal excision for treating early rectal neoplasms not amenable to en bloc resection by conventional colonoscopic techniques. Endoscopic submucosal dissection (ESD) is a revolutionary endoscopic procedure that enables en bloc resection of large rectal neoplasms with low morbidity. To date, no randomized controlled trial can be found in the literature comparing the two modalities.
Objectives: To compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between ESD and TAMIS for early rectal neoplasms.
Design: Prospective randomized controlled trial.
Subjects: One hundred and fourteen consecutive patients diagnosed with early rectal neoplasms (>/=2 cm in size and without evidence of deep submucosal invasion) that are not amenable to en bloc resection by conventional colonoscopic techniques will be recruited.
Interventions: Patients will be randomly allocated to receive either ESD or TAMIS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Short-term morbidity
Time Frame: Up to 1 month
Short-term morbidity/mortality within 30 days after the procedure (including intraprocedural morbidity/mortality), defined by the Clavien-Dindo classification of surgical complications
Secondary Outcomes
- Time to walk independently(Up to 1 month)
- Length of hospital stay(Up to 1 month)
- Direct medical costs(Up to 1 year)
- R0 resection rate(Up to 1 month)
- Anal continence(Up to 1 year)
- Fecal incontinence quality of life (FIQL)(Up to 1 year)
- En bloc resection rate(Up to 1 month)
- Local recurrence(Up to 3 years)
- Time to resume normal diet(Up to 1 month)
- Quality of life measured by the Short Form-36 (SF-36) Health Survey questionnaire(Up to 1 year)
Investigators
Simon S. M. Ng
Professor of Surgery
Chinese University of Hong Kong