Effect of a proton pump inhibitor or an H2-receptor antagonist on prevention of bleeding from ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial.
OBJECTIVE
With conventional methods of endoscopic mucosal resection for early gastric cancer (EGC), proton pump inhibitors (PPIs) and H2-receptor antagonists (H2RAs) have a similar effect on preventing bleeding from artificial ulcers. An objective of this study is to investigate whether a stronger acid suppressant (i.e., PPI) more effectively prevents bleeding after the recent advanced technique of endoscopic submucosal dissection (ESD) for EGC.


METHODS
This was a prospective randomized controlled trial performed in a referral cancer center. A total of 143 patients with EGC who underwent ESD were randomly assigned to the treatment groups. They received either rabeprazole 20 mg (PPI group) or cimetidine 800 mg (H2RA group) on the day before ESD and continued for 8 wk. The primary end point was the incidence of bleeding that was defined as hematemesis or melena that required endoscopic hemostasis and decreased the hemoglobin count by more than 2 g/dL.


RESULTS
In baseline data, the endoscopists who performed the ESD were significantly different between the groups. Finally, 66 of 73 patients in the PPI group and 64 of 70 in the H2RA group were analyzed. Bleeding occurred in four patients in the PPI group and 11 in the H2RA group (P= 0.057). Multivariate analysis revealed that treatment with the PPI significantly reduced the risk of bleeding: adjusted hazard ratio 0.47, 95% confidence interval 0.22-0.92, P= 0.028. One delayed perforation was experienced in the H2RA group.


CONCLUSIONS
PPI therapy more effectively prevented delayed bleeding from the ulcer created after ESD than did H2RA treatment.
Uedo
Noriya
N
Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
Takeuchi
Yoji
Y
Yamada
Takuya
T
Ishihara
Ryu
R
Ogiyama
Hideharu
H
Yamamoto
Sachiko
S
Kato
Motohiko
M
Tatsumi
Koichi
K
Masuda
Eriko
E
Tamai
Chie
C
Yamamoto
Shunsuke
S
Higashino
Koji
K
Iishi
Hiroyasu
H
Tatsuta
Masaharu
M
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D002927:Cimetidine / Q000627:therapeutic use*; D005260:Female; D005773:Gastroscopy; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010438:Peptic Ulcer Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D064750:Rabeprazole; D013274:Stomach Neoplasms / Q000601:surgery*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; D064750:Rabeprazole; D002927:Cimetidine