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Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study.
Digestion. 2020 Jun 25 [Online ahead of print]D

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.

Authors+Show Affiliations

Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan, osamu-d@koto.kpu-m.ac.jp.Department of Gastroenterology and Hepatology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan.Department of Gastroenterology, Asahi University Hospital, Gifu, Japan.Department of Gastroenterology, Matsushita Memorial Hospital, Osaka, Japan.Department of Gastroenterology, Kyoto Yamashiro General Medical Center, Kyoto, Japan. Department of Gastroenterology, Saiseikai Kyoto Hospital, Kyoto, Japan.Department of Gastroenterology, Fukuchiyama City Hospital, Kyoto, Japan.Department of Gastroenterology, Maizuru Medical Center, Kyoto, Japan. Department of Gastroenterology, Medical Corporation Keishinkai, Kyoto Kidugawa Hospital, Kyoto, Japan.Department of Gastroenterology and Hepatology, Omihachiman Community Medical Center, Shiga, Japan.Department of Gastroenterology, JCHO Kyoto Kuramaguchi Medical Center, Kyoto, Japan.Department of Gastroenterology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan.Department of Gastroenterology, Otsu City Hospital, Shiga, Japan.Department of Gastroenterology and Hepatology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan.Department of Gastroenterology, Asahi University Hospital, Gifu, Japan.Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32585678

Citation

Ishida, Tsugitaka, et al. "Clinical Outcomes of Vonoprazan-Treated Patients After Endoscopic Submucosal Dissection for Gastric Neoplasms: a Prospective Multicenter Observation Study." Digestion, 2020, pp. 1-11.
Ishida T, Dohi O, Yamada S, et al. Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study. Digestion. 2020.
Ishida, T., Dohi, O., Yamada, S., Yasuda, T., Yamada, N., Tomie, A., Tsuji, T., Horii, Y., Majima, A., Horie, R., Fukui, A., Zen, K., Tomatsuri, N., Yagi, N., Naito, Y., & Itoh, Y. (2020). Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study. Digestion, 1-11. https://doi.org/10.1159/000507807
Ishida T, et al. Clinical Outcomes of Vonoprazan-Treated Patients After Endoscopic Submucosal Dissection for Gastric Neoplasms: a Prospective Multicenter Observation Study. Digestion. 2020 Jun 25;1-11. PubMed PMID: 32585678.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study. AU - Ishida,Tsugitaka, AU - Dohi,Osamu, AU - Yamada,Shinya, AU - Yasuda,Takeshi, AU - Yamada,Nobuhisa, AU - Tomie,Akira, AU - Tsuji,Toshifumi, AU - Horii,Yusuke, AU - Majima,Atsushi, AU - Horie,Ryusuke, AU - Fukui,Akifumi, AU - Zen,Keika, AU - Tomatsuri,Naoya, AU - Yagi,Nobuaki, AU - Naito,Yuji, AU - Itoh,Yoshito, Y1 - 2020/06/25/ PY - 2020/02/13/received PY - 2020/04/09/accepted PY - 2020/6/26/entrez PY - 2020/6/26/pubmed PY - 2020/6/26/medline KW - Delayed bleeding KW - Endoscopic submucosal dissection KW - Ulcer healing KW - Vonoprazan SP - 1 EP - 11 JF - Digestion JO - Digestion N2 - 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. SN - 1421-9867 UR - https://www.unboundmedicine.com/medline/citation/32585678/Clinical_Outcomes_of_Vonoprazan-Treated_Patients_after_Endoscopic_Submucosal_Dissection_for_Gastric_Neoplasms:_A_Prospective_Multicenter_Observation_Study L2 - https://www.karger.com?DOI=10.1159/000507807 DB - PRIME DP - Unbound Medicine ER -
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