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

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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Procedure: ESD; Procedure: TAMIS; Procedure: TEO

Detailed Description

A multicenter non-inferiority randomized clinical trial is proposed to compare two types of treatment for early rectal neoplastic lesions. Study arms:

1. Endoscopic treatment: Endoscopic Submucosal Dissection (ESD)
2. 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 Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diego de Frutos, MD; Phone Number: +34600826265; Email: diegodefrutos@gmail.com
• Study Contact Backup: Name: Alberto Herreros de Tejada, MD, PhD; Email: alberto.herreros@salud.madrid.org

Study Locations

• Spain
  • Barcelona, Spain
    • Not yet recruiting
    • Hospital de Sant Joan Despí Moisès Broggi
    • Contact: David Barquero
  • Madrid, Spain
    • Not yet recruiting
    • Hospital General Universitario Gregorio Maranon
    • Contact: Oscar Nogales
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Jose Carlos Marín
  • Cantabria
    • Santander, Cantabria, Spain
      • Not yet recruiting
      • Hospital Universitario Marques de Valdecilla
      • Contact: Álvaro Terán
  • Madrid
    • Boadilla Del Monte, Madrid, Spain
      • Not yet recruiting
      • Hospital Universitario HM Monteprincipe
      • Contact: Felipe Ramos
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Universitario Puerta de Hierro
      • Contact: Diego de Frutos, MD; Phone Number: 600826265; Email: diegodefrutos@gmail.com
  • Malaga
    • Málaga, Malaga, Spain
      • Not yet recruiting
      • Hospital Quirónsalud Málaga
      • Contact: Pedro Rosón, MD
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Not yet recruiting
      • Complejo Hospitalario de Navarra
      • Contact: Eduardo Albeniz, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Alberto Herreros de Tejada Echanojáuregui
• Collaborators: Spanish Society of Digestive Endoscopy
• Investigators: Study Director: Eduardo Albéniz, MD, PhD, Complejo Hospitalario de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Recurrence; ESD; Early Rectal Neoplasms; TAMIS; TEO; R0
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: DSETAMIS-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No