ENDOSCOPIC SUBMUCOSAL DISSECTION VERSUS LOCAL LAPAROSCOPIC SURGICAL RESECTION (TRANSANAL MINIMALLY INVASIVE SURGERY [TAMIS] TRANSANAL ENDOSCOPIC OPERATION [TEO]) IN EARLY RECTAL NEOPLASIAS (DSETAMIS-2018 STUDY). PRELIMINARY RESULTS

D de Frutos; J Santiago; E Albéniz; P Rosón; JC Marín; Ó Nogales; F Ramos; D Barquero; Á Terán; AH de Tejada; DSETAMIS-2018. Endoscopic Resection Group of the Spanish Society of Gastrointestinal Endoscopy (GR-SEED)

doi:10.1055/s-0040-1704418

Endoscopy, Table of Contents

Endoscopy 2020; 52(S 01): S135-S136
DOI: 10.1055/s-0040-1704418

ESGE Days 2020 ePoster Podium presentations

Thursday, April 23, 2020 09:30 – 10:00 ESD 1 ePoster Podium 7

ENDOSCOPIC SUBMUCOSAL DISSECTION VERSUS LOCAL LAPAROSCOPIC SURGICAL RESECTION (TRANSANAL MINIMALLY INVASIVE SURGERY [TAMIS] TRANSANAL ENDOSCOPIC OPERATION [TEO]) IN EARLY RECTAL NEOPLASIAS (DSETAMIS-2018 STUDY). PRELIMINARY RESULTS

D de Frutos

¹Puerta de Hierro University Hospital, Gastroenterology Department, Endoscopy Unit,Madrid, Spain

²IDIPHISA-Research Institute Segovia Arana, Majadahonda, Spain

,

J Santiago

²IDIPHISA-Research Institute Segovia Arana, Majadahonda, Spain

³Puerta de Hierro University Hospital, Gastroenterology Department, Endoscopy Unit, Majadahonda, Spain

,

E Albéniz

⁴Complejo Hospitalario de Navarra, Gastroenterology Department, Endoscopy Unit, Pamplona, Spain

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P Rosón

⁵Hospital Quiron Salud Malaga, Gastroenterology Department, Endoscopy Unit, Málaga, Spain

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JC Marín

⁶Hospital 12 de Octubre, Gastroenterology Department, Endoscopy Unit, Madrid, Spain

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Ó Nogales

⁷Hospital General Universitario Gregorio Marañon, Gastroenterology Department, Endoscopy Unit, Madrid, Spain

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F Ramos

⁸Hospital Universitario HM Montepríncipe, Gastroenterology Department, Endoscopy Unit, Boadilla del Monte, Spain

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D Barquero

⁹Hospital Universitario de Bellvitge, Hospital de Sant Joan Despí Moisès Broggi, Gastroenterology Department, Endoscopy Unit, Barcelona, Spain

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Á Terán

¹⁰Hospital Universitario Marqués de Valdecilla, Gastroenterology Department, Endoscopy Unit, Santander, Spain

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AH de Tejada

²IDIPHISA-Research Institute Segovia Arana, Majadahonda, Spain

³Puerta de Hierro University Hospital, Gastroenterology Department, Endoscopy Unit, Majadahonda, Spain

,

DSETAMIS-2018. Endoscopic Resection Group of the Spanish Society of Gastrointestinal Endoscopy (GR-SEED)

› Author Affiliations

Abstract

Full Text

Aims Endoscopic Submucosa Dissection (ESD) and laparoscopic surgical resection techniques (Transanal minimally invasive surgery (TAMIS) and Transanal endoscopic operation (TEO)) have demonstrated high rates of curative resection in Early Rectal Neoplasias (ERN), although no randomized studies comparing both strategies have been published. We present the preliminary results of the DSETAMIS-2018 study.

To compare ESD and TAMIS/TEO (T/T) in recurrence rate (3-6-12 months), en-bloc & R0 resection rate, time of procedure and safety.

Methods Prospective multicentric randomized no-inferiority clinical trial. Consecutive patients with non-pedunculated ERN >20 mm, between 3-14 cm from the external anal verge, involving less than 50% of the rectum circumference and without signs of deep invasion were eligible. The estimated sample size is 34 cases per study group for a non-inferiority limit of 10%, power of 80% (beta 0.2) and alpha error 0.05. This study is registered in clinicaltrials.gov (NCT03959839).

Results From April 2019 20 patients fulfilled the inclusion criteria and were invited to. Seven patients were finally randomized (4 ESD, 3 T/T), whereas 13 patients declined and choose the endoscopic treatment (ESD). The preliminary results of the randomized patients are shown in [Table 1].

Tab. 1
Preliminary results
	ESD	TAMIS/TEO	p Value
En-bloc (%)	100	66.7	0.42
R0 (%)	100	33.3	0.18
Lesion size, mm Media (SD)	53.5 (9.2)	36.3 (8.1)	0.16
Time per procedure, min Media (SD)	69.5 (2.1)	51.7 (28.4)	0.39

Conclusions This is one of the first randomized clinical trials comparing ESD with surgical endoscopic treatment in ERN. Recruitment is limited by patient’s preference towards ESD and restrictive inclusion criteria due to technical limitations of surgical procedures. Preliminary results show a remarkable en-bloc and R0 resection in ESD group.

NOTE: These results may be updated in final presentation if this abstract is accepted