DSETAMIS2018: Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias

Sponsor

Dr. Alberto Herreros de Tejada Echanojáuregui (Other)

Overall Status

Recruiting

CT.gov ID

NCT03959839

Collaborator

Spanish Society of Digestive Endoscopy (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

8.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasms	Procedure: ESD Procedure: TAMIS Procedure: TEO	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endoscopic Treatment Rectal Endoscopic Submucosal Dissection	Procedure: ESD Rectal Endoscopic Submucosal Dissection
Experimental: Minimally Invasive Laparoscopic Local Surgical Treatment Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)	Procedure: TAMIS Transanal Minimally Invasive Surgery Procedure: TEO Transanal Endoscopic Operation

Arm

Intervention/Treatment

Experimental: Endoscopic Treatment

Rectal Endoscopic Submucosal Dissection

Procedure: ESD

Rectal Endoscopic Submucosal Dissection

Experimental: Minimally Invasive Laparoscopic Local Surgical Treatment

Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)

Procedure: TAMIS

Transanal Minimally Invasive Surgery

Procedure: TEO

Transanal Endoscopic Operation

Outcome Measures

Primary Outcome Measures

local recurrence rate [12 months]
presence of remaining neoplastic tissue in resection site

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria	Spain
2	Hospital Universitario HM Montepríncipe	Boadilla Del Monte	Madrid	Spain
3	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid	Spain	28222
4	Hospital QuironSalud Málaga	Málaga	Malaga	Spain
5	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain	31008
6	Hospital de Sant Joan Despí Moisès Broggi	Barcelona		Spain
7	Hospital General Universitario Gregorio Marañón	Madrid		Spain
8	Hospital Universitario 12 de Octubre	Madrid		Spain