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CC BY-NC-ND 4.0 · Endoscopy
DOI: 10.1055/a-2452-4607
Original article

Efficacy and safety of endoscopic ultrasonography-guided ethanol injections of small pancreatic neuroendocrine neoplasms: a prospective multicenter study

Kazuyuki Matsumoto 
1   Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan (Ringgold ID: RIN92057)
,
Hironari Kato 
1   Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan (Ringgold ID: RIN92057)
,
Takao Itoi
2   Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan (Ringgold ID: RIN13112)
,
Masayuki Kitano 
3   Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (Ringgold ID: RIN13145)
,
Kazuo Hara 
4   Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan (Ringgold ID: RIN538363)
,
Masaki Kuwatani 
5   Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido, Japan (Ringgold ID: RIN163693)
,
Mamoru Takenaka 
6   Gastroenterology and Hepatology, Kindai University Faculty of Medicine Graduate School of Medical Sciences, Osakasayama, Japan (Ringgold ID: RIN38158)
,
Reiko Ashida 
3   Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (Ringgold ID: RIN13145)
,
Shuntaro Mukai 
2   Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan (Ringgold ID: RIN13112)
,
Nozomi Okuno 
4   Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan (Ringgold ID: RIN538363)
,
Kazumichi Kawakubo
5   Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido, Japan (Ringgold ID: RIN163693)
,
Tatsuhiro Yamazaki
1   Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan (Ringgold ID: RIN92057)
,
Jun Sakurai
7   Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan (Ringgold ID: RIN92057)
,
Yuki Nakatsuka
7   Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan (Ringgold ID: RIN92057)
,
Michihiro Yoshida
7   Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan (Ringgold ID: RIN92057)
,
Motoyuki Otsuka
1   Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan (Ringgold ID: RIN92057)
› Author AffiliationsSupported by: Japanese Foundation for Research and Promotion of Endoscopy

Clinical Trial: Registration number (trial ID): jRCTs061200016, Trial registry: Japan Primary Registries Network (http://rctportal.niph.go.jp), Type of Study: Prospective, Muli-Center study, Historical control
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Abstract

Background

Endoscopic ultrasonography (EUS)-guided ethanol injection (EI) has recently been introduced as one of the management strategies for pancreatic neuroendocrine neoplasms (PNENs); however, its role as a surgical alternative is unclear. We evaluated the efficacy and safety of EUS-EI in treating small PNENs through a prospective multicenter study.

Methods

Patients with grade 1 tumors of ≤15 mm confirmed by pathology were included. The primary end point assessed efficacy and safety, measuring complete ablation using computed tomography at 1 and 6 months, prevention of adverse events (AEs) within 1 month, severe pancreatic fistula at 1 month, and incidence/worsening of diabetes mellitus (DM) at 6 months. The composite end point of EUS-EI was compared with that of historical results of a study based on surgical treatment.

Results

25 patients with PNENs, with a median tumor size of 10.1 mm, were treated using EUS-EI. The composite primary end point was achieved by 76.0% of patients (19/25; 95%CI 54.9%–90.6%), a proportion significantly higher than that of surgical treatment (P = 0.008). Regarding efficacy, 88.0% (22/25) of patients achieved complete ablation at 1 and 6 months (95%CI 68.8%–97.5%). Regarding safety, 96.0% (24/25) of patients had no severe AEs within 1 month (95%CI 79.7%–99.9%). No patients had severe pancreatic fistulas at 1 month, and 84.0% (21/25) had no incidence or exacerbation, or both, of DM at 6 months (95%CI 63.9%–95.5%).

Conclusion

EUS-EI is safe and could be a potent treatment option for patients with small PNENs.

Supplementary Material



Publication History

Received: 27 January 2024

Accepted after revision: 24 October 2024

Accepted Manuscript online:
25 October 2024

Article published online:
17 January 2025

© 2025. 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/).

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

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