A randomized controlled trial of rebamipide plus rabeprazole for the healing of artificial ulcers after endoscopic submucosal dissection

Fujiwara, Shoko; Morita, Yoshinori; Toyonaga, Takashi; Kawakami, Fumi; Itoh, Tomoo; Yoshida, Masaru; Kutsumi, Hiromu; Azuma, Takeshi

doi:10.1007/s00535-011-0372-3

Cited by 58 publications

(68 citation statements)

References 21 publications

(28 reference statements)

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“…However, there is no current consensus regarding the optimal duration of PPI or P-CAB treatment after ESD based on the various factors that can influence healing of post-ESD ulcers. Potential predictive factors of delayed ulcer healing include the large size of artificial ulcers [9,10], the use of H2RA after ESD [5,6], preoperative fibrosis in the submucosal layer of the lesions [3], damage to the muscularis propria layer during the ESD procedure [11], location of the resected lesion in the lesser curvature [12], and lesions combined with severe atrophic gastritis [13]. However, these risk factors were identified prior to the release of P-CABs and, therefore, these studies did not consider P-CAB treatment.…”

Section: Introductionmentioning

confidence: 99%

Risk Factors for Delayed Ulcer Healing after Endoscopic Submucosal Dissection of Gastric Neoplasms

Shimozato

Sasaki

Ogasawara

et al. 2017

JGLD

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Background & Aims: With improved technology, the size of artificial ulcers after endoscopic submucosal dissection (ESD) has increased. The aim of our study was to examine the risk factors for delayed gastric ulcer healing after ESD, including the possible benefit of potassium-competitive acid blocker (P-CAB) treatment.Methods: The primary outcome was the rate of healing of the artificial ulcers induced by ESD at 8 weeks post intervention. Design: retrospective case series. Setting: Aichi Medical University Hospital. Patients: patients who underwent ESD for gastric neoplasm, between April 2015 and March 2017. Intervention: ESD, with a follow-up endoscopic examination at 8 weeks post-ESD. Univariate and multivariate analyses were used to identify the independent risk factors for delayed healing.Results: Of the 73 gastric neoplasms included in the analysis, delayed ulcer healing was identified in 21.9%. Dyslipidemia (p=0.04), ESD procedure time (p=0.003) and artificial ulcer size (p<0.001) were identified as risk factors for delayed healing, with location in the lower third of the stomach [Odds ratio (OR) 6.76; p=0.016] and artificial ulcer size (OR, 1.18; p=0.024) retained as independent risk factors. A cut-off ulcer size of 854 mm2 was predictive of delayed healing, with a sensitivity of 29.8% and specificity of 87.5%. For large ulcers, the rate of healing of 70% with vonoprazan was higher than the rate of 47.6% with proton pump inhibitors (PPIs), although this difference was not significant.Conclusion: For artificial ulcers after ESD with a resection diameter >35 mm, it might be desirable to use PPIs for >8 weeks or P-CAB.Abbreviations: EGC: early gastric cancers; EMR: endoscopic mucosal resection; ESD: endoscopic submucosal dissection; H. pylori: Helicobacter pylori; H2RA: H2-receptor antagonist: PRP: platelet rich plasma; PGA: polyglycolic acid; P-CAB: potassium-competitive acid blocker; PPI: proton pump inhibitor.

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Section: Introductionmentioning

confidence: 99%

Risk Factors for Delayed Ulcer Healing after Endoscopic Submucosal Dissection of Gastric Neoplasms

Shimozato

Sasaki

Ogasawara

et al. 2017

JGLD

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“…ESD results in the creation of larger artificial ulcers. Although PPIs are the standard treatment for ESD-induced ulcers and bleeding after ESD, Fujiwara et al (9) reported that treatment with PPIs and acid-suppressive agents alone has limited effects in patients with a low level acid secretion, such as those with severe atrophic conditions in the gastric mucosa. Terano et al (4) reported that, in their study, seven weeks of rebamipide treatment without acid-suppressive agents promoted gastric ulcer healing after eradication therapy compared with a placebo.…”

Section: Discussionmentioning

confidence: 99%

“…In randomized controlled studies, rebamipide has been found to prevent nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers, accelerate gastric ulcer healing and suppress mucosal inflammation in patients with chronic erosive gastritis (6,7). Recently, several studies (8)(9)(10)(11)(12)(13)(14) have examined the efficacy of rebamipide and PPI combination therapy for the treatment of ESD-induced ulcers. However, there is currently no consensus regarding the optimal treatment duration or drug regimen.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Proton Pump Inhibitors (PPIs) Plus Rebamipide for Endoscopic Submucosal Dissection-induced Ulcers: A Meta-analysis

Wang

Guo

et al. 2014

Intern. Med.

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Objective To compare the efficacy of proton pump inhibitors (PPIs) with rebamipide versus PPIs alone for the treatment of ulcers after endoscopic submucosal dissection (ESD). Methods PubMed, Web of Science, Medline, Embase, the Cochrane Central Register of Controlled Trials and China Naitonal Knowledge Infrastructure were searched up to the end of October 2013 in order to identify all randomized controlled trials reporting the effects of PPIs plus rebamipide on healing ulcers after ESD. The outcome measurement was complete ulcer healing. Results A total of six studies involving 724 patients were included. The pooled data suggested a significantly higher rate of ulcer healing after endoscopic therapy among patients treated with PPIs plus rebamipide than among those treated with PPIs alone [odds ratio (OR)=2.40, 95% confidence interval (CI): 1.68-3.44]. The subgroup analysis showed PPI plus rebamipide therapy to be more effective in healing ESD-induced ulcers than treatment with PPIs alone after both four (OR=2.22, 95%CI: 1.53-3.24) and eight weeks of treatment (OR=3.19, 95%CI: 1.22-8.31). In addition, the combination therapy was found to be significantly more effective than the use of PPIs alone for all ESD ulcers greater than 20 mm in size (OR=4.77, 95%CI: 2.22-10.26). There were no significant differences between the treatment groups with regard to ulcer location (low, middle or upper stomach) or the presence of absence of H. pylori infection. No serious adverse events were observed in either group. Conclusion The results of this meta-analysis suggest that treatment with PPIs plus rebamipide is superior to PPI monotherapy for healing ESD-induced ulcers over four weeks, particularly large ulcers. However, more well-designed trials are needed to confirm these findings.

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“…Recently, several randomized controlled trials compared the combination of PPI and mucosal protective agents (being the most promising rebamipide) with PPI monotherapy in the healing of iatrogenic ulcer after ESD. The use of PPI along with rebamipide might increase ulcer healing rates because of the synergic effect of both drugs (104)(105)(106)(107). Helicobacter pylori eradication had no impact on ulcer healing at 2 months follow-up after the procedure (108,109).…”

Section: Pharmacological Treatment Only Two Randomizedmentioning

confidence: 99%

Endoscopic submucosal dissection: Sociedad Española de Endoscopia Digestiva (SEED) clinical guideline

Fernández‐Esparrach¹,

Calderón

Peña

et al. 2014

Rev. esp. enferm. dig.

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A randomized controlled trial of rebamipide plus rabeprazole for the healing of artificial ulcers after endoscopic submucosal dissection

Abstract: Treatment with a PPI plus rebamipide improved healing rates at 8 weeks for patients with ESD-derived artificial ulcer, and appeared to be particularly effective for patients with severe atrophic gastritis.

Cited by 58 publications

References 21 publications

Risk Factors for Delayed Ulcer Healing after Endoscopic Submucosal Dissection of Gastric Neoplasms

Risk Factors for Delayed Ulcer Healing after Endoscopic Submucosal Dissection of Gastric Neoplasms

Efficacy and Safety of Proton Pump Inhibitors (PPIs) Plus Rebamipide for Endoscopic Submucosal Dissection-induced Ulcers: A Meta-analysis

Endoscopic submucosal dissection: Sociedad Española de Endoscopia Digestiva (SEED) clinical guideline

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