Imaeda, H., Hosoe, N., Suzuki, H., Saito, Y., Ida, Y., Nakamura, R., . . . Hibi, T. (2011). Effect of lansoprazole versus roxatidine on prevention of bleeding and promotion of ulcer healing after endoscopic submucosal dissection for superficial gastric neoplasia. Journal of Gastroenterology, 46(11), 1267–1272. 

To compare the effects of a proton-pump inhibitor (PPI) and a histamine 2 receptor antagonist on the prevention of bleeding and promotion of ulcer healing after endoscopic submucosal dissection (ESD) for superficial gastric neoplasia with a secondary aim to compare the cost effectiveness of the two drugs

Patients were randomly assigned to receive either lansoprazole (30 mg IV bid for two days followed by 30 mg PO qd x eight weeks) or roxatidine (75 mg IV bid for two days followed by 75 mg bid x eight weeks). Medication was started the morning following the ESD. Follow-up EGDs were performed the day after the ESD, and at eight weeks. Endoscopists were blind to study groups. Endoscopy was performed the day after ESD, and at the eight week follow-up. CBC drawn the day after ESD. Medication compliance was determined with the remaining medication count at week eight. No discussion of reliability or validity of EGD.

• N = 123  
• MEAN AGE =60.9 years (range= 46–86 years)
• MALES: 80%, FEMALES: 20%
• KEY DISEASE CHARACTERISTICS: Patients with early stage gastric cancer, gastric adenoma, or suspected gastric neoplasia

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: University Hospital in Japan

• PHASE OF CARE: Active antitumor treatment

Prospective, randomized, controlled trial

• Endoscopy
• CBC
• Medication count

There was no significant difference in major (p = 0.68) or minor (p = 1) bleeding between the two groups; there was no significant difference in ulcer healing between the two groups (p = 1). There was a large cost/benefit ratio associated with roxatidine.

There was no difference in bleeding incidence or ulcer healing in subjects after ESD for superficial gastric neoplasia. Additionally, given the cost difference, there is no evidence to support the preferential use of lansoprazole over roxatidine.

• Risk of bias (no control group)
• Measurement validity/reliability questionable
• Questionable protocol fidelity
• Other limitations/explanation: This was a pilot study and very underpowered. Additionally, healing was determined by one endoscopist without confirmation of findings. The presence of a control group that did not receive any medication would have provided further evidence of the efficacies of the studied medications.

Nurses will care for patients with gastric neoplasia post-ESD and need to be cognizant of the risk of bleeding and the potential effect of PPI or histamine 2 receptor antagonists upon this risk.