Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB)
Status:
Withdrawn
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and
mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality
in patients with bleeding peptic ulcers and is now recommended as the first hemostatic
modality for these patients.
In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after
endoscopic therapy has been endorsed in some studies. Laine and Javid et al found that oral
PPI and IV PPI had a similar intragastric pH response in the past two years. Therefore,
whether oral can replace IV in the management of peptic ulcer bleeding is the objective in
this study.
The investigators enrolled 130 patients with active bleeding or nonbleeding visible
vessels（NBVV） in this study. They are randomly assigned as oral lansoprazole or IV nexium
group. All patients receive successful endoscopic therapy with heater probe or hemoclip
placement.
In the lansoprazole group (N=65), 30 mg four times daily is given orally for three days.
Thereafter, the patients receive 30 mg lansoprazole orally daily for two months. In the
nexium group, 160 mg/day continuous infusion is given for three days. Thereafter, the
patients receive 40 mg nexium orally daily for two months.
The primary end point is recurrent bleeding before discharge and within 14 days. At day 14,
volume of blood transfused, number of surgeries performed, and the mortality rates of the two
groups are compared as well.