Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Jul 13;20(1):225.
doi: 10.1186/s12876-020-01367-z.

Transanal minimally invasive surgery (TAMIS) versus endoscopic submucosal dissection (ESD) for resection of non-pedunculated rectal lesions (TRIASSIC study): study protocol of a European multicenter randomised controlled trial

Nik Dekkers  1 , Jurjen J Boonstra  2 , Leon M G Moons  3 , Roel Hompes  4 , Barbara A Bastiaansen  5 , Jurriaan B Tuynman  4 , Arjun D Koch  6 , Bas L A M Weusten  7 , Apollo Pronk  8 , Peter A Neijenhuis  9 , Marinke Westerterp  10 , Wilbert B van den Hout  11 , Alexandra M J Langers  2 , Jolein van der Kraan  2 , Alaa Alkhalaf  12 , Jonathan Y L Lai  13 , Frank Ter Borg  14 , Hans Fabry  15 , Eric Halet  16 , Matthijs P Schwartz  17 , Wouter B Nagengast  18 , Jan Willem A Straathof  19 , Rogier W R Ten Hove  20 , Leendert H Oterdoom  21 , Christiaan Hoff  22 , Eric J Th Belt  23 , David D E Zimmerman  24 , Muhammed Hadithi  25 , Hans Morreau  26 , Erienne M V de Cuba  27 , Jeroen W A Leijtens  28 , Hans F A Vasen  2 , Monique E van Leerdam  2   29 , Eelco J R de Graaf  30 , Pascal G Doornebosch  30 , James C H Hardwick  2
Affiliations

Transanal minimally invasive surgery (TAMIS) versus endoscopic submucosal dissection (ESD) for resection of non-pedunculated rectal lesions (TRIASSIC study): study protocol of a European multicenter randomised controlled trial

Nik Dekkers et al. BMC Gastroenterol. .

Abstract

Background: In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden.

Methods: Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior.

Discussion: This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future.

Trial registration: Netherlands Trial Register, NL7083 , 06 July 2018.

Keywords: Adenoma; Endoscopic submucosal dissection; Rectal cancer; Transanal minimally invasive surgery.

PubMed Disclaimer

Conflict of interest statement

JB is a consultant for Boston Scientific.

Figures

Fig. 1
Fig. 1
Flowchart of the TRIASSIC study. Abbreviations: TAMIS: Transanal Minimally Invasive Surgery, ESD: Endoscopic Submucosal Dissection
See this image and copyright information in PMC

References

    1. gco.iarc.fr [Internet]. Lyon: World Health Organization: The Global Cancer Observatory. [Updated 2019 may; cited 2019 Dec 10] Available from: http://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-she... [.
    1. Toes-Zoutendijk E, Kooyker AI, Elferink MA, Spaander MCW, Dekker E, HJd K, et al. Stage distribution of screen-detected colorectal cancers in the Netherlands. Gut. 2018;67(9):1745–1746. doi: 10.1136/gutjnl-2017-315111. - DOI - PubMed
    1. Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, et al. Colonoscopic Polypectomy and Long-Term Prevention of Colorectal-Cancer Deaths. N Engl J Med. 2012;366(8):687–696. doi: 10.1056/NEJMoa1100370. - DOI - PMC - PubMed
    1. De Graaf EJ, Doornebosch PG, Tollenaar RA, Meershoek-Klein Kranenbarg E, de Boer AC, Bekkering FC, et al. Transanal endoscopic microsurgery versus total mesorectal excision of T1 rectal adenocarcinomas with curative intention. Eur J Surg Oncol. 2009;35(12):1280–1285. doi: 10.1016/j.ejso.2009.05.001. - DOI - PubMed
    1. Barendse RM, Musters GD, de Graaf EJR, van den Broek FJC, Consten ECJ, Doornebosch PG, et al. Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND study) Gut. 2018;67(5):837–846. doi: 10.1136/gutjnl-2016-313101. - DOI - PubMed

Publication types

Grants and funding