Effects of Preoperative Administration of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection(EMR): Prospective, Randomized, Placebo-controlled, Comparative Study
- 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Frequency of bleeding after EMR is performed
4weeks
Yes
MyungKu Choi, MD
Principal Investigator
The Catholic University of Korea
South Korea: Korea Food and Drug Administration (KFDA)
RAB-KOR-9035
NCT00844675
October 2007
March 2012
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