Efficacy and safety of intensive downstaging polypectomy (IDP) for multiple duodenal adenomas in patients with familial adenomatous polyposis: a prospective cohort study

Yoji Takeuchi; Kenta Hamada; Hiroko Nakahira; Yusaku Shimamoto; Hirohisa Sakurai; Yasuhiro Tani; Satoki Shichijo; Akira Maekawa; Takashi Kanesaka; Sachiko Yamamoto; Koji Higashino; Fumie Fujisawa; Yasumasa Ezoe; Hideki Ishikawa; Michihiro Mutoh; Noriya Uedo; Masanori Nojima; Ryu Ishihara

doi:10.1055/a-1983-5963

Endoscopy, Table of Contents

Endoscopy 2023; 55(06): 515-523
DOI: 10.1055/a-1983-5963

Original article

Efficacy and safety of intensive downstaging polypectomy (IDP) for multiple duodenal adenomas in patients with familial adenomatous polyposis: a prospective cohort study

Yoji Takeuchi

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

²Department of Genetic Oncology, Division of Hereditary Tumors, Osaka International Cancer Institute, Osaka, Japan

,

Kenta Hamada

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

³Department of Practical Gastrointestinal Endoscopy, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan

,

Hiroko Nakahira

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

⁴Department of Gastroenterology, Japan Community Health Care Organization Hoshigaoka Medical Center, Osaka, Japan

,

Yusaku Shimamoto

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

⁵Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan

,

Hirohisa Sakurai

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

⁶Department of Gastroenterology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan

,

Yasuhiro Tani

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

,

Satoki Shichijo

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

,

Akira Maekawa

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

,

Takashi Kanesaka

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

,

Sachiko Yamamoto

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

,

Koji Higashino

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

,

Fumie Fujisawa

²Department of Genetic Oncology, Division of Hereditary Tumors, Osaka International Cancer Institute, Osaka, Japan

,

Yasumasa Ezoe

⁷Ishikawa Gastroenterological Medical Clinic, Osaka, Japan

,

Hideki Ishikawa

⁷Ishikawa Gastroenterological Medical Clinic, Osaka, Japan

⁸Department of Molecular-Targeting Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan

,

Michihiro Mutoh

⁸Department of Molecular-Targeting Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan

,

Noriya Uedo

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

,

Masanori Nojima

⁹Center for Translational Research, The Institute of Medical Science Hospital, The University of Tokyo, Tokyo, Japan

,

Ryu Ishihara

¹Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

› Author Affiliations

Abstract

Background Patients with familial adenomatous polyposis (FAP) risk developing multiple duodenal adenomas (MDAs), leading to duodenal cancer and death. We investigated the efficacy and safety of intensive downstaging polypectomy (IDP) for MDAs integrated with new-generation procedures.

Methods This prospective phase II study, conducted at a tertiary cancer center, enrolled patients with FAP who had MDAs. We performed IDP including cold snare/forceps polypectomy (CSP/CFP) and underwater endoscopic mucosal resection (UEMR). The primary end point was the downstaging of Spigelman stage at 1-year follow-up.

Results 2424 duodenal polyps in 58 patients with FAP underwent IDP, including 2413 CSPs in 57 patients, seven CFPs in one patient, and four UEMRs in four patients. Only one major adverse event was observed (grade 3 hyperamylasemia) without clinical manifestations. We performed additional UEMR, CSP, and CFP for one, 12, and 22 patients, respectively, during initial follow-up. Overall, 55 patients completed protocol examination; the Spigelman stage was significantly reduced at the 1-year follow-up endoscopy (P < 0.001), with downstaging observed in 39 patients (71 %). Among the 26 patients with Spigelman stage IV at initial examination and protocol completion, 23 (88 %) showed downstaging. There was no major change in Spigelman stages from 1-year follow-up esophagogastroduodenoscopy to a median of 37 months (range 3–56).

Conclusions IDP, including new-generation procedures, showed significant downstaging with acceptable adverse events for MDA in patients with FAP, even those with advanced-stage disease. Lesion selection for different resection techniques may be important for suitable and sustainable management of MDA in patients with FAP.

Full Text

References

References
1 Groden J, Thliveris A, Samowitz W. et al. Identification and characterization of the familial adenomatous polyposis coli gene. Cell 1991; 66: 589-600
2 Jasperson KW, Tuohy TM, Neklason DW. et al. Hereditary and familial colon cancer. Gastroenterology 2010; 138: 2044-2058
3 Bülow S, Björk J, Christensen IJ. et al. Duodenal adenomatosis in familial adenomatous polyposis. Gut 2004; 53: 381-386
4 Heiskanen I, Kellokumpu I, Järvinen H. Management of duodenal adenomas in 98 patients with familial adenomatous polyposis. Endoscopy 1999; 31: 412-416
5 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
6 Inoue T, Uedo N, Yamashina T. et al. Delayed perforation: a hazardous complication of endoscopic resection for non-ampullary duodenal neoplasm. Dig Endosc 2014; 26: 220-227
7 Groves CJ, Saunders BP, Spigelman AD. et al. Duodenal cancer in patients with familial adenomatous polyposis (FAP): results of a 10-year prospective study. Gut 2002; 50: 636-641
8 Hamada K, Takeuchi Y, Ishikawa H. et al. Feasibility of cold snare polypectomy for multiple duodenal adenomas in patients with familial adenomatous polyposis: a pilot study. Dig Dis Sci 2016; 61: 2755-2759
9 Hamada K, Takeuchi Y, Ishikawa H. et al. Safety of cold snare polypectomy for duodenal adenomas in familial adenomatous polyposis: a prospective exploratory study. Endoscopy 2018; 50: 511-517
10 Maruoka D, Matsumura T, Kasamatsu S. et al. Cold polypectomy for duodenal adenomas: a prospective clinical trial. Endoscopy 2017; 49: 776-783
11 Yamasaki Y, Uedo N, Takeuchi Y. et al. Underwater endoscopic mucosal resection for superficial nonampullary duodenal adenomas. Endoscopy 2018; 50: 154-158
12 Shichijo S, Takeuchi Y, Kitamura M. et al. Does cold snare polypectomy completely resect the mucosal layer? A prospective single-center observational trial. J Gastroenterol Hepatol 2020; 35: 241-248
13 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
14 Takimoto K, Ueda T, Shimamoto F. et al. Sedation with dexmedetomidine hydrochloride during endoscopic submucosal dissection of gastric cancer. Dig Endosc 2011; 23: 176-181
15 Kawamura T, Takeuchi Y, Asai S. et al. A comparison of the resection rate for cold and hot snare polypectomy for 4–9 mm colorectal polyps: a multicentre randomized controlled trial (CRESCENT study). Gut 2018; 67: 1950-1957
16 Takeuchi Y, Mabe K, Shimodate Y. et al. Continuous anticoagulation and cold snare polypectomy versus heparin bridging and hot snare polypectomy in patients on anticoagulants with subcentimeter polyps: a randomized controlled trial. Ann Intern Med 2019; 171: 229-237
17 Takimoto K, Matsuura N, Nakano Y. et al. Efficacy of polyglycolic acid sheeting with fibrin glue for perforations related to gastrointestinal endoscopic procedures: a multicenter retrospective cohort study. Surg Endosc 2022; 36: 5084-5093
18 Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut 2002; 51: 130-131
19 Spigelman AD, Williams CB, Talbot IC. et al. Upper gastrointestinal cancer in patients with familial adenomatous polyposis. Lancet 1989; 2: 783-785
20 Lepistö A, Kiviluoto T, Halttunen J. et al. Surveillance and treatment of duodenal adenomatosis in familial adenomatous polyposis. Endoscopy 2009; 41: 504-509
21 National Cancer Institute. Common terminology criteria for adverse events v4.0. Available at (Accessed 26 Oct 2022): https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5x11.pdf
22 Ishikawa H, Yamada M, Sato Y. et al. Intensive endoscopic resection for downstaging of polyp burden in patients with familial adenomatous polyposis (J-FAPP Study III): a multicenter prospective interventional study. Endoscopy 2022;
23 Roos VH, Bastiaansen BA, Kallenberg FGJ. et al. Endoscopic management of duodenal adenomas in patients with familial adenomatous polyposis. Gastrointest Endosc 2021; 93: 457-466
24 Giardiello FM, Yang VW, Hylind LM. et al. Primary chemoprevention of familial adenomatous polyposis with sulindac. N Engl J Med 2002; 346: 1054-1059
25 Samadder NJ, Neklason DW, Boucher KM. et al. Effect of sulindac and erlotinib vs. placebo on duodenal neoplasia in familial adenomatous polyposis: a randomized clinical trial. JAMA 2016; 315: 1266-1275
26 Takeuchi Y, Shichijo S, Uedo N. et al. Safety and efficacy of cold versus hot snare polypectomy including colorectal polyps ≥1 cm in size. Dig Endosc 2022; 34: 274-283
27 Takeuchi Y, Shichijo S, Uedo N. et al. Underwater endoscopic mucosal resection for colorectal lesions: can it be an “Underwater” revolution?. DEN Open 2022; 2: e84
28 Nakahira H, Takeuchi Y, Kanesaka T. et al. Wide-field underwater EMR followed by line-assisted complete closure for a large duodenal adenoma [Video]. VideoGIE 2019; 4: 469-471
29 Fukuda H, Takeuchi Y, Shoji A. et al. Curative value of underwater endoscopic mucosal resection for submucosally invasive colorectal cancer. J Gastroenterol Hepatol 2021; 36: 2471-2478
30 Matsueda K, Takeuchi Y, Kitamura M. et al. Depth of the cutting plane with underwater and conventional endoscopic mucosal resection: post-hoc analysis of a randomized study. J Gastroenterol Hepatol 2022; 37: 741-748
31 Ignjatovic A, East JE, Suzuki N. et al. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol 2009; 10: 1171-1178
32 Takeuchi Y, Hanafusa M, Kanzaki H. et al. An alternative option for “resect and discard” strategy, using magnifying narrow-band imaging: a prospective “proof-of-principle” study. J Gastroenterol 2015; 50: 1017-1026

Supplementary Material

Supplementary material