ESD Versus TAMIS for Early Rectal Neoplasms

Study Overview
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Brief Summary
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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
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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. Outcome measures: Primary outcome: 30-day morbidity/mortality defined by the Clavien-Dindo classification. Secondary outcomes: hospital stay, functional outcomes and quality of life, overall costs, R0 resection rate, and recurrence rate. Conclusions: Results of the present study can provide evidence-based clarification of the efficacy and safety of ESD in treating early rectal neoplasms. The Investigators hypothesize that ESD is associated with lower morbidity, shorter hospital stay, and similar R0 resection rate when compared with TAMIS. A faster recovery and earlier discharge after ESD may reduce financial burden to the hospital/healthcare system. The results of this proposed project may have a significant impact on the future treatment strategy for early rectal neoplasms.

Official Title
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Endoscopic Submucosal Dissection (ESD) Versus Transanal Minimally Invasive Surgery (TAMIS) for Early Rectal Neoplasms: a Prospective Randomized Controlled Trial

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Procedure: ESD
* Procedure: TAMIS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESD<br>ESD is an endoscopic procedure that enables en bloc resection of large tumors in the gastrointestinal tract, irrespective of the size of the lesion. ESD uses an electrosurgical cutting device to purposely dissect the deeper layers of the submucosa to remove neoplastic mucosal lesions in a single piece. | Procedure: ESD<br>* Refer to arm description<br>|
| Active Comparator: TAMIS<br>TAMIS is a minimally invasive means of removing large rectal neoplastic lesions not accessible by conventional transanal excision. It is performed using the GelPOINT path transanal access platform and laparoscopic instruments. | Procedure: TAMIS<br>* Refer to arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term morbidity | Short-term morbidity/mortality within 30 days after the procedure (including intraprocedural morbidity/mortality), defined by the Clavien-Dindo classification of surgical complications | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En bloc resection rate | Resection with a single piece | Up to 1 month | 
| R0 resection rate | Complete resection of the neoplasm with clear lateral and deep margins at histology | Up to 1 month | 
| Time to resume normal diet |  | Up to 1 month | 
| Time to walk independently |  | Up to 1 month | 
| Length of hospital stay |  | Up to 1 month | 
| Anal continence | Measured by the Wexner's score | Up to 1 year | 
| Fecal incontinence quality of life (FIQL) | Measured by the FIQL questionnaire | Up to 1 year | 
| Quality of life measured by the Short Form-36 (SF-36) Health Survey questionnaire | SF-36 Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Up to 1 year | 
| Direct medical costs |  | Up to 1 year | 
| Local recurrence |  | Up to 3 years |