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
the Dutch eFTR Working Group
(2022) BMC Gastroenterology, volume 22, issue 1, pp. 1 - 12
(Article)
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
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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 ).
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Keywords: Colorectal cancer, Endoscopic full-thickness resection, Minimal invasive local treatment options, T1 colorectal cancer, Gastroenterology
ISSN: 1471-230X
Publisher: BioMed Central
Note: Funding Information: This study is funded by the Maarten van der Weijden foundation and the application has undergone full external peer review by the funding body. The funding body had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Funding Information: 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. Funding Information: We thank all participating endoscopists and centers of the eFTR Working Group for their contributions. Coordinating center: Amsterdam University Medical Center, Amsterdam, The Netherlands. Principal investigator: Prof. E. Dekker, MD, PhD Coordinating investigators: B.A.J. Bastiaansen, MD & L.M.G. Moons, MD, PhD Participating centers and principal investigators: Alrijne Hospital, Leiderdorp, The Netherlands, Department of Gastroenterology and Hepatology. Dr. W.R. ten Hove, MD, PhD Albert Schweitzer Hospital, Dordrecht, The Netherlands, Department of Gastroenterology and Hepatology. Dr. W. van de Vrie, MD, PhD Amphia Hospital, Breda, The Netherlands, Department of Gastroenterology and Hepatology. Dr. T.C.J. Seerden, MD, PhD Amsterdam University Medical Centers location AMC, Amsterdam, The Netherlands, Department of Pathology. Dr. A. Farina Sarasqueta, MD, PhD Amsterdam University Medical Centers location AMC, Amsterdam, The Netherlands, Department of Surgery. Dr. R. Hompes, MD, PhD Antonie van Leeuwenhoek Hospital, The Netherlands, Department of Gastroenterology and Hepatology. Dr. T.D. de Wijkerslooth, MD, PhD Catharina Hospital, Eindhoven, The Netherlands, Department of Gastroenterology and Hepatology. Dr. R.M. Schreuder, MD, PhD Dijklander Hospital, Hoorn, The Netherlands, Department of Gastroenterology and Hepatology. Drs. M.S. Vlug, MD Deventer Hospital, Deventer, The Netherlands, Department of Gastroenterology and Hepatology. Dr. F. ter Borg, MD, PhD Elisabeth Tweesteden Hospital, Tilburg, The Netherlands, Department of Gastroenterology and Hepatology. Dr. W.L. Hazen, MD, PhD Flevoziekenhuis, Almere, The Netherlands, Department of Gastroenterology and Hepatology. Dr. M.W. Mundt, MD, PhD Gelderse Vallei, Ede, The Netherlands, Department of Gastroenterology and Hepatology. Drs. P.R. Bos, MD Haaglanden Medical Center, the Hague, The Netherlands, Department of Gastroenterology and Hepatology. Dr. L.E. Perk, MD, PhD Haga Hospital, the Hague, The Netherlands, Department of Gastroenterology and Hepatology. Dr. M.H.M.G. Houben, MD, PhD Isala Clinics, Zwolle, The Netherlands, Department of Gastroenterology and Hepatology. Drs. H. van der Sluis, MD Ijsselland Hospital, Capelle aan den IJssel, The Netherlands, Department of Gastroenterology and Hepatology. Dr. F.C. Bekkering, MD, PhD Jeroen Bosch Hospital, Den Bosch, The Netherlands, Department of Gastroenterology and Hepatology. Dr. J.S. Terhaar sive Droste, MD, PhD Leiden University Medical Center, Leiden, The Netherlands, Department of Gastroenterology and Hepatology. Dr. J.J. Boonstra, MD, PhD Leiden University Medical Center, Leiden, The Netherlands, Department of Surgery. Dr. K.C.M.J. Peeters, MD, PhD Maastricht University Medical Center, Maastricht, The Netherlands, Department of Gastroenterology and Hepatology. Drs. R.J.J. de Ridder, MD Martini Hospital, Groningen, The Netherlands, Department of Gastroenterology and Hepatology. Drs. H.J. Wolters, MD Maxima Medical Center, Veldhoven, The Netherlands, Department of Gastroenterology and Hepatology. Dr. J.W.A. Straathof, MD, PhD Meander Medical Center, Amersfoort, The Netherlands, Department of Gastroenterology and Hepatology. Dr. M.P. Schwartz, MD, PhD Nij Smellinghe, Drachten, The Netherlands, Department of Gastroenterology and Hepatology. Drs. F.J. Rando Muñoz, MD Noordwest Hospital Group, Alkmaar, The Netherlands, Department of Gastroenterology and Hepatology. Drs. B.W. van der Spek, MD OLVG, Amsterdam, The Netherlands, Department of Gastroenterology and Hepatology. Dr. S.T. Rietdijk, MD, PhD Radboud University Medical Center, Nijmegen, The Netherlands, Department of Gastroenterology and Hepatology. Drs. G.J. Bulte, MD Reinier de Graaf Hospital, Delft, The Netherlands, Department of Gastroenterology and Hepatology. Dr. R. Quispel, MD, PhD Rode Kruis Hospital, Beverwijk, The Netherlands, Department of Gastroenterology and Hepatology. Drs. E.A.R. Gielisse, MD St. Antonius Hospital, Nieuwegein, The Netherlands, Department of Gastroenterology and Hepatology. Prof. dr. B.L.A.M. Weusten, MD, PhD University Medical Center Groningen, Groningen, The Netherlands, Department of Gastroenterology and Hepatology. Prof. dr. W.B. Nagengast, MD, PhD University Medical Center Utrecht, Utrecht, The Netherlands, Department of Gastroenterology and Hepatology. Dr. L.M.G. Moons, MD, PhD University Medical Center Utrecht, Utrecht, The Netherlands, Department of Pathology. Dr. M.M. Lacle, MD, PhD Publisher Copyright: © 2022, The Author(s).
(Peer reviewed)
