Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study

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Abstract

Background: Vonoprazan (VPZ) has the potential to prevent delayed bleeding and promote ulcer healing after endoscopic submucosal dissection (ESD) similar to proton pump inhibitors (PPIs). Objective: We aimed to evaluate the outcomes of VPZ-treated patients after ESD and compared the efficacy and feasibility in preventing a delayed bleeding and in healing an artificial ulcer after ESD between the VPZ and PPI therapies. Methods: This was a prospective, observation study in 11 Japanese medical institutions. We enrolled and evaluated 223 patients who underwent gastric ESD followed by VPZ treatment (VPZ group). We selected 385 patients who underwent gastric ESD followed by PPI treatment as historical controls (PPI group) to compare the outcomes between the VPZ and PPI groups using a propensity score matching analysis. Results: Among the 223 patients treated with VPZ, 173 were men and 50 were women with a median age of 72 years and with a median tumor size of 12.0 mm. Rates of en bloc resection and complete resection were 99.1 and 94.2%, respectively. Lymphovascular invasion was found in 6 (6.3%) cases. Intraoperative perforation and delayed bleeding occurred in 3 (1.3%) and 10 patients (4.5%), respectively. Scarring of artificial post-ESD ulcer was found in 153 patients (68.6%) at 6 weeks after ESD. The 205 pairs of propensity score-matched patients were comparable between the VPZ and PPI groups. The rate of delayed bleeding in the VPZ and PPI groups was 3.9 and 4.4%, respectively (difference, 0.5 percentage points; 95% confidence interval, −3.7 to 2.8%; non-inferiority, p = 0.01). Therefore, VPZ therapy demonstrated non-inferiority against PPI therapy in reducing the rate of delayed bleeding. The scar-stage ulcer at 6 weeks in the VPZ group and 8 weeks in the PPI group was 68.3 and 74.6%, respectively ( p = 0.19). Conclusions: VPZ therapy showed an efficacy and feasibility in preventing a delayed bleeding after ESD similar to the PPI therapy. VPZ for 6 weeks and PPI for 8 weeks were similarly effective for an artificial ulcer healing after ESD.

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Most cited references 31

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Endoscopic mucosal resection for treatment of early gastric cancer.

H. Ono, H Kondo, T Gotoda … (2001)

In Japan, endoscopic mucosal resection (EMR) is accepted as a treatment option for cases of early gastric cancer (EGC) where the probability of lymph node metastasis is low. The results of EMR for EGC at the National Cancer Center Hospital, Tokyo, over a 11 year period are presented. EMR was applied to patients with early cancers up to 30 mm in diameter that were of a well or moderately histologically differentiated type, and were superficially elevated and/or depressed (types I, IIa, and IIc) but without ulceration or definite signs of submucosal invasion. The resected specimens were carefully examined by serial sections at 2 mm intervals, and if histopathology revealed submucosal invasion and/or vessel involvement or if the resection margin was not clear, surgery was recommended. Four hundred and seventy nine cancers in 445 patients were treated by EMR from 1987 to 1998 but submucosal invasion was found on subsequent pathological examination in 74 tumours. Sixty nine percent of intramucosal cancers (278/405) were resected with a clear margin. Of 127 cancers without "complete resection", 14 underwent an additional operation and nine were treated endoscopically; the remainder had intensive follow up. Local recurrence in the stomach occurred in 17 lesions followed conservatively, in one lesion treated endoscopically, and in five lesions with complete resection. All tumours were diagnosed by follow up endoscopy and subsequently treated by surgery. There were no gastric cancer related deaths during a median follow up period of 38 months (3-120 months). Bleeding and perforation (5%) were two major complications of EMR but there were no treatment related deaths. In our experience, EMR allows us to perform less invasive treatment without sacrificing the possibility of cure.

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Incidence of lymph node metastasis from early gastric cancer: estimation with a large number of cases at two large centers.

Akio Yanagisawa, Mitsuru Sasako, Tadakazu Shimoda … (2000)

BACKGROUND: The presence of lymph node metastasis (LNM) is the most important prognostic factor for patients with early gastric cancer (EGC). A D2 gastrectomy has been the gold standard treatment. Strict criteria for endoscopic mucosal resection have been widely accepted in Japan. There are some trials aimed at expanding the indications for local treatment, although there has not been a comprehensive review of the risk of LNM with the lesions of EGC.METHODS: We investigated 5265 patients who had undergone gastrectomy with lymph node dissection for EGC at the National Cancer Center Hospital and the Cancer Institute Hospital. Nine clinicopathological factors were assessed for their possible association with LNM.RESULTS: None of the 1230 well differentiated intramucosal cancers of less than 30 mm diameter regardless of ulceration findings, were associated with metastases (95% confidence interval [CI], 0-0.3%). None of the 929 lesions without ulceration were associated with nodal metastases (95% CI, 0-0.4%) regardless of tumor size. Similarly to findings for intramucosal cancers, for submucosal lesions, there was a significant correlation between tumor size larger than 30 mm and lymphatic-vascular involvement with an increased risk of LNM. None of the 145 differentiated adenocarcinomas of less than 30-mm-diameter without lymphatic or venous permeation were associated with LNM, provided that the lesion had invaded less than 500 &mgr;m into the submucosa (95% CI, 0-2.5%).CONCLUSION: Based on our large series of cases, we have been able to clarify the risks associated with EGC and to propose expansion of the criteria for local treatment. However, accurate histological evaluation of the resected specimens is essential to avoid recurrence for such EGCs that should be cured.

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Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection--an analysis of risk factors.

T Gotoda, C. Yokoi, K Takizawa … (2008)

Endoscopic submucosal dissection (ESD) has been reported to be associated with a higher complication rate than standard endoscopic mucosal resection. We aimed to clarify the risk factors for delayed bleeding after ESD for early gastric cancer (EGC). 1083 EGCs in 968 consecutive patients undergoing ESD during a 4-year period were reviewed. Post-ESD coagulation (PEC) preventive therapy of visible vessels in the resection area, using a coagulation forceps, was introduced and mostly performed during the later 2 years. Various factors related to patients, tumors, and treatment including PEC were investigated using univariate and multivariate analysis with regard to delayed post-ESD bleeding, evidenced by hematemesis or melena, that required endoscopic treatment. Delayed bleeding occurred after ESD of 63 lesions (5.8 % of all lesions and 6.5 % of patients), controlled in all cases by endoscopic hemostasis; blood transfusion was required in only one case. Tumor location in the upper third of the stomach and PEC were independent factors indicating a lower rate of delayed bleeding according to both univariate and multivariate analysis. This retrospective study suggested that preventive coagulation of visible vessels in the resection area after ESD may lead to a lower bleeding rate.

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Author and article information

Journal

Journal ID (publisher-id): DIG

Journal ID (nlm-ta): Digestion

Journal ID (doi): 10.1159/issn.0012-2823

Title: Digestion

Publisher: S. Karger AG

ISSN (Print): 0012-2823

ISSN (Electronic): 1421-9867

Publication date Subscription-year: 2021

Publication date (Print): May 2021

Publication date (Electronic): 25 June 2020

Volume: 102

Issue: 3

Pages: 386-396

Affiliations

[_a] _aDepartment of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan

[_b] _bDepartment of Gastroenterology and Hepatology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan

[_c] _cDepartment of Gastroenterology, Asahi University Hospital, Gifu, Japan

[_d] _dDepartment of Gastroenterology, Matsushita Memorial Hospital, Osaka, Japan

[_e] _eDepartment of Gastroenterology, Kyoto Yamashiro General Medical Center, Kyoto, Japan

[_f] _fDepartment of Gastroenterology, Saiseikai Kyoto Hospital, Kyoto, Japan

[_g] _gDepartment of Gastroenterology, Fukuchiyama City Hospital, Kyoto, Japan

[_h] _hDepartment of Gastroenterology, Maizuru Medical Center, Kyoto, Japan

[_i] _iDepartment of Gastroenterology, Medical Corporation Keishinkai, Kyoto Kidugawa Hospital, Kyoto, Japan

[_j] _jDepartment of Gastroenterology and Hepatology, Omihachiman Community Medical Center, Shiga, Japan

[_k] _kDepartment of Gastroenterology, JCHO Kyoto Kuramaguchi Medical Center, Kyoto, Japan

[_l] _lDepartment of Gastroenterology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan

[_m] _mDepartment of Gastroenterology, Otsu City Hospital, Shiga, Japan

Author notes

*Dr. Osamu Dohi, Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Hirokoji Kamigyo-kuKyoto 602-8566 (Japan), osamu-d@koto.kpu-m.ac.jp

Author information

Osamu Dohi https://orcid.org/0000-0002-0498-0144

Yuji Naito https://orcid.org/0000-0001-5443-788X

Article

Publisher ID: 507807 Other ID: Digestion 2021;102:386–396

DOI: 10.1159/000507807

PubMed ID: 32585678

SO-VID: c28b8103-7e1c-4113-990d-4219919169fe

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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

History

Date received : 13 February 2020

Date accepted : 09 April 2020

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Figures: 4, Tables: 5, Pages: 11

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Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study

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Karger: Gastroenterology

Most cited references 31

Endoscopic mucosal resection for treatment of early gastric cancer.

Incidence of lymph node metastasis from early gastric cancer: estimation with a large number of cases at two large centers.

Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection--an analysis of risk factors.

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