Clinical Trial

. 2023 Apr;55(4):344-352.

doi: 10.1055/a-1945-9120. Epub 2022 Oct 10.

Intensive endoscopic resection for downstaging of polyp burden in patients with familial adenomatous polyposis (J-FAPP Study III): a multicenter prospective interventional study

Hideki Ishikawa¹, Masayoshi Yamada², Yasushi Sato³, Shinji Tanaka⁴, Chino Akiko⁵, Masahiro Tajika⁶, Hisashi Doyama⁷, Tetsuji Takayama⁸, Yoshio Ohda⁹, Takahiro Horimatsu¹⁰, Yasushi Sano¹¹, Kohji Tanakaya¹², Hiroaki Ikematsu¹³, Yoshihisa Saida¹⁴, Hideyuki Ishida¹⁵, Yoji Takeuchi¹⁶, Hiroshi Kashida¹⁷, Shinsuke Kiriyama¹⁸, Shinichiro Hori¹⁹, Kyowon Lee²⁰, Jun Tashiro²¹, Nozomu Kobayashi²², Takeshi Nakajima², Sadao Suzuki²³, Michihiro Mutoh^{1

24}; J-FAPP Study III Group

Affiliations

¹ Department of Molecular-Targeting Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.
² Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
³ Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Hokkaido, Japan.
⁴ Endoscopy and Medicine, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan.
⁵ Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan.
⁶ Department of Endoscopy, Aichi Cancer Center Hospital, Aichi, Japan.
⁷ Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.
⁸ Department of Gastroenterology and Oncology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
⁹ Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.
¹⁰ Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
¹¹ Sano Hospital, Hyogo, Japan.
¹² Department of Surgery, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Japan.
¹³ Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
¹⁴ Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan.
¹⁵ Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
¹⁶ Department of Gastrointestinal Oncology, Osaka International Cancer Institute (formerly Osaka Medical Center for Cancer and Cardiovascular Diseases), Osaka, Japan.
¹⁷ Department of Gastroenterology and Hepatology, Kindai University, Osaka, Japan.
¹⁸ Department of Surgery, Gunma Chuo Hospital, Gunma, Japan.
¹⁹ Department of Internal Medicine, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
²⁰ Moriguchi Keijinkai Hospital, Osaka, Japan.
²¹ Department of Gastroenterology, Toshiba Hospital, Tokyo, Japan.
²² Department of Gastroenterology, Tochigi Cancer Center, Tochigi, Japan.
²³ Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.
²⁴ Epidemiology and Prevention Group, Research Center for Cancer Prevention and Screening/Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.

PMID: 36216266
PMCID: PMC10060053
DOI: 10.1055/a-1945-9120

Clinical Trial

Intensive endoscopic resection for downstaging of polyp burden in patients with familial adenomatous polyposis (J-FAPP Study III): a multicenter prospective interventional study

Hideki Ishikawa et al. Endoscopy. 2023 Apr.

. 2023 Apr;55(4):344-352.

doi: 10.1055/a-1945-9120. Epub 2022 Oct 10.

Authors

Affiliations

¹ Department of Molecular-Targeting Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.
² Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
³ Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Hokkaido, Japan.
⁴ Endoscopy and Medicine, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan.
⁵ Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan.
⁶ Department of Endoscopy, Aichi Cancer Center Hospital, Aichi, Japan.
⁷ Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.
⁸ Department of Gastroenterology and Oncology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
⁹ Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.
¹⁰ Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
¹¹ Sano Hospital, Hyogo, Japan.
¹² Department of Surgery, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Japan.
¹³ Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
¹⁴ Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan.
¹⁵ Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
¹⁶ Department of Gastrointestinal Oncology, Osaka International Cancer Institute (formerly Osaka Medical Center for Cancer and Cardiovascular Diseases), Osaka, Japan.
¹⁷ Department of Gastroenterology and Hepatology, Kindai University, Osaka, Japan.
¹⁸ Department of Surgery, Gunma Chuo Hospital, Gunma, Japan.
¹⁹ Department of Internal Medicine, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
²⁰ Moriguchi Keijinkai Hospital, Osaka, Japan.
²¹ Department of Gastroenterology, Toshiba Hospital, Tokyo, Japan.
²² Department of Gastroenterology, Tochigi Cancer Center, Tochigi, Japan.
²³ Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.
²⁴ Epidemiology and Prevention Group, Research Center for Cancer Prevention and Screening/Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.

PMID: 36216266
PMCID: PMC10060053
DOI: 10.1055/a-1945-9120

Abstract

Background: Total colectomy is the standard treatment for familial adenomatous polyposis (FAP). Recently, an increasing number of young patients with FAP have requested the postponement of surgery or have refused to undergo surgery. We aimed to evaluate the effectiveness of intensive endoscopic removal for downstaging of polyp burden (IDP) in FAP.

Method: A single-arm intervention study was conducted at 22 facilities. Participants were patients with FAP, aged ≥ 16 years, who had not undergone colectomy or who had undergone colectomy but had ≥ 10 cm of large intestine remaining. For IDP, colorectal polyps of ≥ 10 mm were removed, followed by polyps of ≥ 5 mm. The primary end point was the presence/absence of colectomy during a 5-year intervention period.

Results: 222 patients were eligible, of whom 166 had not undergone colectomy, 46 had undergone subtotal colectomy with ileorectal anastomosis, and 10 had undergone partial resection of the large intestine. During the intervention period, five patients (2.3 %, 95 % confidence interval [CI] 0.74 %-5.18 %) underwent colectomy, and three patients died. Completion of the 5-year intervention period without colectomy was confirmed in 150 /166 patients who had not undergone colectomy (90.4 %, 95 %CI 84.8 %-94.4 %) and in 47 /56 patients who had previously undergone colectomy (83.9 %, 95 %CI 71.7 %-92.4 %).

Conclusion: IDP in patients with mild-to-moderate FAP could have the potential to be a useful means of preventing colorectal cancer without implementing colectomy. However, if the IDP protocol was proposed during a much longer term, it may not preclude the possibility that a large proportion of colectomies may still need to be performed.

Trial registration: ClinicalTrials.gov NCT03567863.

The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

PubMed Disclaimer

Conflict of interest statement

T. Takayama received a research grant from Fujifilm Co., Ltd., outside the submitted work. S. Hori received personal fees from Fujifilm Co., Ltd., Fujifilm Medical Co., Ltd., and Kaneka Medix Co., Ltd., outside the submitted work. Y. Takeuchi received personal fees from Olympus, Boston Scientific Japan, Daiichi-Sankyo, Miyarisan Pharmaceutical, Asuka Pharmaceutical, AstraZeneca, EA Pharma, Zeria Pharmaceutical, Fujifilm, Kaneka Medix, and Kyorin Pharmaceutical, outside the submitted work. H. Ishikawa, M. Yamada, Y. Sato, S. Tanaka, C. Akiko, M. Tajika, H. Doyama, Y. Ohda, T. Horimatsu, Y. Sano, K. Tanakaya, H. Ikematsu, Y. Saida, H. Ishida, H. Kashida, S. Kiriyama, K. Lee, J. Tashiro, N. Kobayashi, T. Nakajima, S. Suzuki, and M. Mutoh declare that they have no conflict of interest.

Figures

**Fig. 1**
Submucosal invasive cancer found in the transverse colon. a Case 1 – Colonoscopic examination performed 160 days after the preceding examination detected a IIa lesion, 5 mm in diameter, in the transverse colon. b Case 2 – Colonoscopic examination performed 181 days after the preceding examination detected IIa + IIc lesions, 5 mm in diameter, in the transverse colon.

**Fig. 2**
Flow chart of study participants.

**Fig. 3**
Cumulative incidence of high grade dysplasia and intramucosal cancer during the intervention period.

See this image and copyright information in PMC

Comment in

Is there a role for endoscopic management of the large bowel in familial adenomatous polyposis?
Latchford A, Clark S. Latchford A, et al. Endoscopy. 2023 Apr;55(4):353-354. doi: 10.1055/a-1990-1046. Epub 2023 Jan 26. Endoscopy. 2023. PMID: 36702130 No abstract available.

References

1. Iwama T, Tamura K, Morita T et al.A clinical overview of familial adenomatous polyposis derived from the database of the polyposis registry of Japan. Int J Clin Oncol. 2004;9:308–316. - PubMed
1. Vasen H F, Möslein G, Alonso A et al.Guidelines for the clinical management of familial adenomatous polyposis (FAP) Gut. 2008;57:704–713. - PubMed
1. Smith A J, Lewis J J, Merchant N B et al.Surgical management of intra-abdominal desmoid tumours. Br J Surg. 2000;87:608–613. - PubMed
1. Nielsen M, Hes F J, Nagengast F M et al.Germline mutations in APC and MUTYH are responsible for the majority of families with attenuated familial adenomatous polyposis. Clin Genet. 2007;71:427–433. - PubMed
1. Tomita N, Ishida H, Tanakaya K et al.Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines: 2020 for the Clinical Practice of Hereditary Colorectal Cancer. Int J Clin Oncol. 2021:26; 1353–1419. - PMC - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Intensive endoscopic resection for downstaging of polyp burden in patients with familial adenomatous polyposis (J-FAPP Study III): a multicenter prospective interventional study

Affiliations

Intensive endoscopic resection for downstaging of polyp burden in patients with familial adenomatous polyposis (J-FAPP Study III): a multicenter prospective interventional study

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Comment in

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous