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Effects of Preoperative Administration of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection(EMR): Prospective, Randomized, Placebo-controlled, Comparative Study

Phase 4
18 Years
70 Years
Not Enrolling
Early Gastric Adenocarcinoma, Adenocarcinoma, Tubular

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Trial Information

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.

Inclusion Criteria:

- Patients who have EMR planned as well as meet the criteria described below will be
selected as study subjects

- Patients in whom EMR is indicated:

1. Gastric adenoma

2. Early gastric adenocarcinoma

- Moderately or well differentiated adenocarcinoma

- Gastric cancer limited to only mucosa on endoscopic ultrasonography

- No invasion of lymph nodes or metastases (diagnosed by CT)

3. EMR to be performed for other diagnostic purposes

- Women of child-bearing potential should avoid pregnancy

- Subjects who consented to a EMR procedure in writing

Exclusion Criteria:

- Patients who meet the criteria described below should be excluded from study

1. Younger than 18 years old

2. Patients with a history of upper gastrointestinal surgery or vagotomy

3. Patients with serious adverse reactions secondary to cardiac, renal, hepatic,
or hematologic diseases (e.g. creatinine> 2.5 mg/dl, total bilirubin >3.0 mg/dl)

4. Patients with diseases that may have a great impact on the clinical study

5. Patients to whom the stimulation of gastrointestinal movement poses risks as in
gastrointestinal bleeding, mechanical ileus and perforation

6. Women who are pregnant or nursing

7. Patients who are being treated with adrenocorticoid steroids, nonsteroidal
anti-inflammatory drugs including aspirin, or other ulcer inducers

8. Patients who are taking other antiulcer drugs (antacids, antihistamines, etc)
that may affect the efficacy assessments of the study drug (but, except for
patients not taking the drugs over 7 days)

9. Patients with severe psychiatric diseases

10. Patients who received other investigational drugs within 30 days prior to the
start of this study or who are currently participating in other clinical study

11. Patients who did not consent to the clinical study

12. Patients who can not be examined

- Patients with bleeding tendency

- Patients with esophageal varices

- Patients with esophageal ulcer, stricture, or obstruction

- Patients who have pacemaker or implantable cardiac defibrillator in place

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Frequency of bleeding after EMR is performed

Outcome Time Frame:


Safety Issue:


Principal Investigator

MyungKu Choi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Catholic University of Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

October 2007

Completion Date:

March 2012

Related Keywords:

  • Early Gastric Adenocarcinoma
  • Adenocarcinoma, Tubular
  • endoscopic mucosal resection
  • Proton Pump Inhibitor
  • gastrointestinal hemorrhage
  • rabeprazole
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Hemorrhage
  • Stomach Neoplasms