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

Rectal Neoplasms Clinical Trial

— DSETAMIS2018  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03959839
• Other study ID #: DSETAMIS-2018
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: September 2020
• Source: Puerta de Hierro University Hospital
• Contact: Diego de Frutos, MD
• Phone: +34600826265
• Email: diegodefrutos[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Procedure:
• ESD
Rectal Endoscopic Submucosal Dissection
• TAMIS
Transanal Minimally Invasive Surgery
• TEO
Transanal Endoscopic Operation

Locations

Country	Name	City	State
Spain	Hospital de Sant Joan Despí Moisès Broggi	Barcelona
Spain	Hospital Universitario HM Montepríncipe	Boadilla Del Monte	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital QuironSalud Málaga	Málaga	Malaga
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Alberto Herreros de Tejada Echanojáuregui	SPANISH SOCIETY OF DIGESTIVE ENDOSCOPY

Country where clinical trial is conducted

Spain, 

Outcome

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