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. 2022 Dec 13;22(1):516.
doi: 10.1186/s12876-022-02591-5.

Long-term oncological outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC (LOCAL-study): study protocol of a national prospective cohort study

L W Zwager  1   2   3 , L M G Moons  4 , A Farina Sarasqueta  5 , M M Laclé  6 , S C Albers  1   2   3 , R Hompes  7 , K C M J Peeters  8 , F C Bekkering  9 , J J Boonstra  10 , F Ter Borg  11 , P R Bos  12 , G J Bulte  13 , E A R Gielisse  14 , W L Hazen  15 , W R Ten Hove  16 , M H M G Houben  17 , M W Mundt  18 , W B Nagengast  19 , L E Perk  20 , R Quispel  21 , S T Rietdijk  22 , F J Rando Munoz  23 , R J J de Ridder  24 , M P Schwartz  25 , R M Schreuder  26 , T C J Seerden  27 , H van der Sluis  28 , B W van der Spek  29 , J W A Straathof  30 , J S Terhaar Sive Droste  31 , M S Vlug  32 , W van de Vrie  33 , B L A M Weusten  34 , T D de Wijkerslooth  35 , H J Wolters  36 , P Fockens  1   2   3 , E Dekker  1   2   3 , B A J Bastiaansen  37   38   39 ; the Dutch eFTR Working Group
Affiliations

Long-term oncological outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC (LOCAL-study): study protocol of a national prospective cohort study

L W Zwager et al. BMC Gastroenterol. .

Abstract

Background: T1 colorectal cancer (CRC) without histological high-risk factors for lymph node metastasis (LNM) can potentially be cured by endoscopic resection, which is associated with significantly lower morbidity, mortality and costs compared to radical surgery. An important prerequisite for endoscopic resection as definite treatment is the histological confirmation of tumour-free resection margins. Incomplete resection with involved (R1) or indeterminate (Rx) margins is considered a strong risk factor for residual disease and local recurrence. Therefore, international guidelines recommend additional surgery in case of R1/Rx resection, even in absence of high-risk factors for LNM. Endoscopic full-thickness resection (eFTR) is a relatively new technique that allows transmural resection of colorectal lesions. Local scar excision after prior R1/Rx resection of low-risk T1 CRC could offer an attractive minimal invasive strategy to achieve confirmation about radicality of the previous resection or a second attempt for radical resection of residual luminal cancer. However, oncologic safety has not been established and long-term data are lacking. Besides, surveillance varies widely and requires standardization.

Methods/design: In this nationwide, multicenter, prospective cohort study we aim to assess feasibility and oncological safety of completion eFTR following incomplete resection of low-risk T1 CRC. The primary endpoint is to assess the 2 and 5 year luminal local tumor recurrence rate. Secondary study endpoints are to assess feasibility, percentage of curative eFTR-resections, presence of scar tissue and/or complete scar excision at histopathology, safety of eFTR compared to surgery, 2 and 5 year nodal and/or distant tumor recurrence rate and 5-year disease-specific and overall-survival rate.

Discussion: Since the implementation of CRC screening programs, the diagnostic rate of T1 CRC is steadily increasing. A significant proportion is not recognized as cancer before endoscopic resection and is therefore resected through conventional techniques primarily reserved for benign polyps. As such, precise histological assessment is often hampered due to cauterization and fragmentation and frequently leads to treatment dilemmas. This first prospective trial will potentially demonstrate the effectiveness and oncological safety of completion eFTR for patients who have undergone a previous incomplete T1 CRC resection. Hereby, substantial surgical overtreatment may be avoided, leading to treatment optimization and organ preservation. Trial registration Nederlands Trial Register, NL 7879, 16 July 2019 ( https://trialregister.nl/trial/7879 ).

Keywords: Colorectal cancer; Endoscopic full-thickness resection; Minimal invasive local treatment options; T1 colorectal cancer.

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Conflict of interest statement

Dr. Bastiaansen received a speakers’ fee Ovesco Endoscopy AG, outside the submitted work. Prof. dr. Dekker has endoscopic equipment on loan of FujiFilm, received a research grant from FujiFilm, received a honorarium for consultancy from FujiFilm, Olympus, GI Supply, CPP-FAP, PAION and Ambu, and a speakers' fee from Olympus, Roche, Tillots, GI Supply, Norgine, FujiFilm en IPSEN. Prof. dr. Weusten received research support from Pentax Medical Inc and Aqua Medical, outside the submitted work. Prof. dr. Fockens reports personal fees from Cook, Ethicon and Olympus, research support from Boston Scientific, outside the submitted work. Dr. L.M.G. Moons is a consultant for Boston Scientific. All other authors have nothing to disclose.

Figures

Fig. 1
Fig. 1
Trial design
Fig. 2
Fig. 2
Schematic illustration of the resection procedure (image used with permission from Ovesco Endoscopy AG from www.ovesco.com)
See this image and copyright information in PMC

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