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Optimal surveillance interval after piecemeal endoscopic mucosal resection for large colorectal neoplasia: a multicenter randomized controlled trial

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Abstract

Background and aims

Colorectal neoplastic lesions (≥ 20 mm) are commonly treated via piecemeal endoscopic mucosal resection (p-EMR) but have a high rate of local recurrence. We aimed to clarify the optimal surveillance interval after p-EMR for these neoplasias.

Methods

In this multicenter (15 participating institutions) prospective, randomized trial, 180 patients recruited over a 4-year period and were classified based on tumor location, tumor diameter, histological diagnosis, institution, and number of resected specimens. The patients underwent curative p-EMR followed by scheduled surveillance colonoscopy at 3, 6, 12, and 24 months after p-EMR (group A; n = 90) or at 6, 12, and 24 months after p-EMR (group B; n = 90). The primary endpoint was cumulative local recurrence at 6 months after p-EMR. Secondary endpoints included local recurrence and the cumulative surgical resection rate of recurrent tumors during the 24-month follow-up period.

Results

The median tumor diameter was 25 mm (IQR 20–30). Six months after p-EMR, 12 and 6 local recurrences were noted in groups A and B, which corresponded to 13 and 8 recurrences, respectively, during the 24-month surveillance period. The primary and secondary endpoints of recurrence were not significantly different between the groups on either intention-to-treat or per-protocol analysis; no surgery case was observed in group B when a strict surveillance protocol of 6-, 12-, and 24-month follow-up post-EMR was followed.

Conclusions

For patients who underwent p-EMR for neoplastic lesions, additional postprocedural 3-month surveillance did not show superior results in detecting recurrence compared with a 6-month surveillance interval.

Clinical trial registration: UMIN000015740.

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Abbreviations

APC:

Argon plasma coagulation

CS:

Colonoscopy

EMR:

Endoscopic mucosal resection

ESD:

Endoscopic submucosal dissection

ITT:

Intention-to-treat

p-EMR:

Piecemeal endoscopic mucosal resection

PP:

Per-protocol

HGD/Tis:

High-grade dysplasia/intramucosal carcinoma

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Acknowledgements

We are deeply grateful to Dr. Yasuhiro Ohno (National Cancer Center East Hospital), Dr. Tomoaki Shinohara (Saku Central Hospital), Dr. Hisashi Doyama (Ishikawa Prefectural Central Hospital), and Dr. Yuichiro Yamaguchi (Shizuoka Cancer Center) for their immense support with enrolling the patients and explaining the study design to them, as well as for insightful comments on the manuscript and the overall study.

Funding

This work was supported by The National Cancer Center Research and Development Fund (21-25, 29-A-13). The funder had no role in designing the study, handling the data, or in the preparation and publication of the manuscript.

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Authors and Affiliations

  1. Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Takeshi Nakajima, Taku Sakamoto, Takahisa Matsuda & Yutaka Saito

  2. Department of Endoscopy, NHO Shikoku Cancer Center, Matsuyama, Ehime, Japan

    Shinichiro Hori

  3. Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan

    Shinya Yamada

  4. Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan

    Hiroaki Ikematsu

  5. Department of Gastroenterology, Okayama University Hospital, Okayama, Japan

    Keita Harada

  6. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

    Han-Mo Chiu

  7. Department of Surgery, Gunma Chuo Hospital, Maebashi, Gunma, Japan

    Shinsuke Kiriyama

  8. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

    Tomoki Michida

  9. Department of Gastroenterology, Saku Central Hospital, Nagano, Japan

    Kinichi Hotta

  10. Department of Gastroenterology, Juntendo University Hospital, Tokyo, Japan

    Naoto Sakamoto

  11. Gastroenterology Center, Hanwa Sumiyoshi General Hospital, Osaka, Japan

    Takashi Abe

  12. Gastroenterological Medicine, Cancer Institute Hospital, Ariake, Tokyo, Japan

    Akiko Chino

  13. Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan

    Masakatsu Fukuzawa

  14. Department of Gastroenterology, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan

    Nozomu Kobayashi

  15. Yamagata Prefectural Central Hospital, Yamagata, Japan

    Kazutoshi Fukase

  16. Department of Medical Statistics, Toho University, Tokyo, Japan

    Yoshitaka Murakami

  17. Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan

    Hideki Ishikawa

Authors
  1. Takeshi Nakajima
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  2. Taku Sakamoto
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  3. Shinichiro Hori
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  4. Shinya Yamada
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  5. Hiroaki Ikematsu
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  6. Keita Harada
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  7. Han-Mo Chiu
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  8. Shinsuke Kiriyama
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  9. Tomoki Michida
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  10. Kinichi Hotta
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  11. Naoto Sakamoto
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  12. Takashi Abe
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  13. Akiko Chino
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  14. Masakatsu Fukuzawa
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  15. Nozomu Kobayashi
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  16. Kazutoshi Fukase
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  17. Takahisa Matsuda
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  18. Yoshitaka Murakami
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  19. Hideki Ishikawa
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  20. Yutaka Saito
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Contributions

YS and TN involved in study concept and design and drafted the manuscript. TN, SH, SY, HI, KH, H-MC, SK, TM, KH, NS, TA, AC, MF, NK, KF, TS, TM, and YS participated in acquisition of data. HI, TN, TS, and YS performed the analysis and interpretation of data. YS and TS contributed to the critical revision of the manuscript for important intellectual content. YM did statistical analysis. YS involved in funding acquisition.

Corresponding author

Correspondence to Yutaka Saito.

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Disclosures

Takeshi Nakajima, Taku Sakamoto, Shinichiro Hori, Shinya Yamada, Hiroaki Ikematsu, Keita Harada, Han-Mo Chiu, Shinsuke Kiriyama, Tomoki Michida, Kinichi Hotta, Naoto Sakamoto, Takashi Abe, Akiko Chino, Masakatsu Fukuzawa, Nozomu Kobayashi, Kazutoshi Fukase, Takahisa Matsuda, Yoshitaka Murakami, Hideki Ishikawa, and Yutaka Saito have no conflicts of interest or financial ties to disclose.

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Nakajima, T., Sakamoto, T., Hori, S. et al. Optimal surveillance interval after piecemeal endoscopic mucosal resection for large colorectal neoplasia: a multicenter randomized controlled trial. Surg Endosc 36, 515–525 (2022). https://doi.org/10.1007/s00464-021-08311-6

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  • DOI: https://doi.org/10.1007/s00464-021-08311-6

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