Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias

Study Overview
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Brief Summary
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A multicenter non-inferiority randomized clinical trial to compare Endoscopic treatment (ESD) and Minimally Invasive Laparoscopic Local Surgical Treatment (TAMIS or TEO) for early rectal neoplastic lesions (adenoma & T1CRC) Primary aim: To compare the long-term local recurrence rate (12 months after the procedure) Secondary aims: Compare en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate, safety (rate of complications), morbidity and cost-effectiveness analyses.

Detailed Description
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A multicenter non-inferiority randomized clinical trial is proposed to compare two types of treatment for early rectal neoplastic lesions. Study arms: Endoscopic treatment: Endoscopic Submucosal Dissection (ESD) Minimally invasive laparoscopic local surgical treatment: Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO). Aims: Primary aim: To compare the long-term local recurrence rate (12 months after the procedure) of rectal lesions after ESD vs Surgical treatment (TAMIS/TEO). Secondary aims: Both arms of the study are compared according to other efficacy-related variables (en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate [6 months]), safety (rate of complications), morbidity (comparing different specific indexes: Wexner index, EQ-5L-5D, etc) and cost-effectiveness analyses (QALY). Inclusion criteria: Patients older than 18 y/o Non-pedunculated rectal lesions (sessile 0-Is or flat 0-II) greater than 20 mm in diameter. The edges of the lesion should be more than 3 cm from the external anal margin and up to 14 cm from it. Circumferential involvement <50% Exclusion criteria: Patients who refuse to participate. Diagnosis of inflammatory bowel disease with rectal involvement. Pregnant. Anorectal fibrosis due to previous anorectal surgery. Lateral Spreading Lesions (LST classification) Granular Homogeneous type Lesions greater than 50 mm when there is suspicion of advanced histology (Kudo Vi superficial pattern). Rectal lesions of any size with high suspicion of deep submucosal invasion or locoregional lymph node involvement, either in the diagnostic colonoscopy (Kudo Vn crypt pattern, NICE 3 pattern, Sano IIIB pattern) or by complementary imaging tests (rectal EUS/Pelvic MRI) Existence of synchronous colorectal lesions that require other surgical treatment in any case. N-size estimation: Assuming a global rate of long-term local recurrence in rectal lesions treated by TAMIS/TEO or ESD of 2.5% (using the data available in the medical literature), considering a non-inferiority limit of 10%, power of 80% (Beta error 0.2, alpha error 0.05) and assuming a loss of patients during the follow-up around 10%, 34 patients per group are required. Follow-up and Information collect: The follow-up will be of 1 year from the date of the intervention and the visits in which the information to be analyzed will be collected are adjusted to the usual clinical practice. The data would be registered using the on-line database system for medical research RedCap. Other information: The entire protocol of this study has been approved by de Ethical Committee on Clinical Research of the Puerta de Hierro University Hospital. The study counts with a Civil Responsibility Insurance policy.

Official Title
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Endoscopic Submucosal Dissection Versus Local Laparoscopic Surgical Resection (Transanal Minimally Invasive Surgery [TAMIS] / Transanal Endoscopic Operation [TEO]) In Early Rectal Neoplasias. Multicentric and Randomized Clinical Trial

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Procedure: ESD
* Procedure: TAMIS
* Procedure: TEO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 y/o Non-pedunculated rectal lesions (sessile 0-Is or flat 0-II) greater than 20 mm in diameter. The edges of the lesion should be more than 3 cm from the external anal margin and up to 14 cm from it. Circumferential involvement <50% Exclusion Criteria: Patients who refuse to participate. Diagnosis of inflammatory bowel disease with rectal involvement. Pregnant. Anorectal fibrosis due to previous anorectal surgery. Lateral Spreading Lesions (LST classification) Granular Homogeneous type Lesions greater than 50 mm when there is suspicion of advanced histology (Kudo Vi superficial pattern). Rectal lesions of any size with high suspicion of deep submucosal invasion or locoregional lymph node involvement, either in the diagnostic colonoscopy (Kudo Vn pit pattern, NICE 3 pattern, Sano IIIB pattern) or by complementary imaging tests (rectal EUS/Pelvic MRI) Existence of synchronous colorectal lesions that require other surgical treatment in any case.

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: Endoscopic Treatment<br>Rectal Endoscopic Submucosal Dissection | Procedure: ESD<br>* Rectal Endoscopic Submucosal Dissection<br>|
| Experimental: Minimally Invasive Laparoscopic Local Surgical Treatment<br>Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO) | Procedure: TAMIS<br>* Transanal Minimally Invasive Surgery<br>Procedure: TEO<br>* Transanal Endoscopic Operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence rate | presence of remaining neoplastic tissue in resection site | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En-bloq resection rate | Single piece of resection specimen | 1 hour | 
| R0 resection rate | Free margin of neoplastic tissue both laterally and deep | 1 hour | 
| Time per procedure | The length of the procedure expressed in minutes | 1 hour | 
| Length of hospital stay | Days of hospital stay | 1 hour | 
| Early complications rate | Registration of any deviations on the normal postoperative period in the first 24 hours | 1 hour | 
| Delayed complications rate | Registration of any deviations on the normal postoperative period after the first 24 hours and up to 30 days after the procedure | 1 hour | 
| Morbidity | Changes in patients' quality of life using validated scores (both, specific and non-specific) | 12 months | 
| Cost-effectiveness analyses (QALY) | Cost-effectiveness analyses usin QALYs | 12 months | 
| Short-term local recurrence rate | Presence of remaining neoplastic tissue in resection site | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Rectal Neoplasms, ESD, TAMIS, TEO, Recurrence, R0, Safety