Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection
Condition: Early Gastric Adenocarcinoma; Adenocarcinoma, Tubular
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is:

        -  To examine if oral administration of Pariet (proton pump inhibitor, 20mg tablets, twice
           daily for 5 days) before Endoscopic mucosal resection(EMR) exhibits preventive effects
           of ulcer bleeding compared with placebo group (preoperative administration of placebo)

        -  To evaluate the effects on the suppression of acid secretion of preoperative
           administration of an Proton pump inhibitor
    

Detailed description: 
      -  Endoscopic mucosal resection (EMR) is less invasive than surgery and is known to be
           general treatment for early gastric cancer or gastric adenoma when patients' quality of
           life is taken into consideration. However, major complications such as bleeding and
           perforation remain to be problematic.1-5 The incidence of these complications is
           expected to rise as the size of lesions for which EMR is indicated has enlarged.
           Histamine 2 receptor antagonists (H2RA) and proton pump inhibitors (PPI) have been used
           for the bleeding,1-3 but the bleeding rate following EMR has been reported to be still
           high as 1.4% to 24%.1,4 Green et al and Berstad et al cited in their research that
           intragastric PH should be sustained above 5.4 to prevent bleeding, and PPIs should be
           administered instead of H2RAs to keep PH above 5.4. Being studied are administration
           modalities to enhance the therapeutic efficacy of PPIs or H2RAs.1-3 Several studies have
           already demonstrated that high-dose PPI therapy, for which a PPI was administered twice
           daily, effectively blocks acid secretion by increasing intragastric pH to neutral.3 Our
           study team also suggested in a previous study that high-dose PPI therapy was adequate to
           maintain intragastric pH above 6.

        -  PPIs are known to induce the suppression of acid secretion because they destroy a proton
           pump, yet it takes 5 days to achieve their maximum effects.7,8 It's been suggested that
           the onset of PPIs is slow to prevent bleeding with administration of a PPI after EMR.4
           Therefore, our investigators expect that 5-day administration of an oral PPI before EMR
           would increase intragastric pH to above 6 and would be at least equal to or superior to
           intravenous PPIs currently being used in terms of the suppression of acid secretion.

        -  This is a prospective, randomized, comparative study to substantiate that oral
           administration of rabeprazole (Pariet tablets) 20mg twice daily before and after EMR (PO
           RBP group) will show similar effects on the prevention of bleeding compared with the
           conventional treatment with iv administration of pantoprazole after EMR but no special
           medication given before EMR (Placebo group). In addition, we are going to measure
           intragastric pH among part of study subjects and then to evaluate if the effect of acid
           suppression in the PO RBP group is superior to that in the placebo group.
    

Intervention name(s): rabeprazole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The rabeprazole group will receive oral rabeprazole 20mg twice day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).; The placebo group will receive a placebo by mouth twice a day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).
Other intervention name(s): Pariet(rabeprazole)
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: endoscopic mucosal resection; Proton Pump Inhibitor; gastrointestinal hemorrhage; rabeprazole