Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study
- 25 June 2020
- journal article
- research article
- Published by S. Karger AG in Digestion
- Vol. 102 (3), 386-396
- https://doi.org/10.1159/000507807
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.Keywords
This publication has 31 references indexed in Scilit:
- Gastric ESD under Heparin Replacement at High-Risk Patients of Thromboembolism Is Technically Feasible but Has a High Risk of Delayed Bleeding: Osaka University ESD Study GroupGastroenterology Research and Practice, 2013
- A Multicenter Survey of the Management After Gastric Endoscopic Submucosal Dissection Related to Postoperative BleedingDigestive Diseases and Sciences, 2011
- PROSPECTIVE SINGLE-ARM TRIAL OF TWO-WEEK RABEPRAZOLE TREATMENT FOR ULCER HEALING AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTIONDigestive Endoscopy, 2011
- A Study Comparing the Antisecretory Effect of TAK-438, a Novel Potassium-Competitive Acid Blocker, with Lansoprazole in AnimalsThe Journal of pharmacology and experimental therapeutics, 2011
- CURRENT MANAGEMENTS AND OUTCOMES OF PEPTIC AND ARTIFICIAL ULCER BLEEDING IN JAPANDigestive Endoscopy, 2010
- Risk factors for bleeding after endoscopic submucosal dissection for gastric lesionsWorld Journal of Gastroenterology, 2010
- Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection - An analysis of risk factorsEndoscopy, 2008
- Endoscopic submucosal dissection with insulated-tip knife for large mucosal early gastric cancer: a feasibility study (with videos)Gastrointestinal Endoscopy, 2007
- Outcomes of Endoscopic Submucosal Dissection for Colorectal Epithelial Neoplasms in 200 Consecutive CasesClinical Gastroenterology and Hepatology, 2007
- Endoscopic mucosal resection for treatment of early gastric cancerGut, 2001