The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric cancer bleeding in inoperable patients.
Tumor bleeding frequently occurs in inoperable gastric cancer patients. Inoperable gastric cancer usually has a large ulcer with friable tumor vessels. Acidic environment in stomach prevents adequate function of coagulation cascade and decrease clot stability. Gastric cancer bleeding may cause significant morbidity and often delays scheduled chemotherapy. National Center Center data showed that about 30% of gastric cancer patient undergoing palliative chemotherapy eventually experience significant cancer bleeding during the treatment period. Once bleeding occurs, endoscopic management is more difficult in gastric cancer patients than in patients with benign peptic ulcers, because the malignant ulcer bed has significant fibrosis. Consequently, gastric cancer patient has a high risk of rebleeding. Proton pump inhibitor (PPI, lansoprazole for example) decrease gastric acid secretion by inhibiting H+,K+-ATPase, and subsequently stabilize blood clot. PPIs are commonly used for benign peptic ulcer or reflux esophagitis, and PPI can decrease recurrent benign ulcer bleeding or other ulcer complications. Moreover, it was reported to prevent bleeding from NSAID or aspirin induced gastric ulcer. Because PPIs are very safe, and they are even available as over-the-counter drugs in some countries. Furthermore, the drug has no interaction with major chemotherapeutic agents commonly used for gastric cancer. Moreover, the drugs are prescribed to the gastric cancer patients when tumor bleeding occurs. Although gastric cancer bleeding is not uncommon and clinically challenging problem, there has been no recommended measure to prevent cancer bleeding. Also there has been no report about the efficacy of PPIs on the gastric cancer bleeding prevention up to now.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
394
Lansoprazole 30 mg, daily
Placebo, daily
Kosin University Gospel Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
National Cancer Center
Goyang, South Korea
Gyeong Sang National University Hospital
Jinju, South Korea
Time-to-bleeding event
Evaluation of the effect of PPI on the prevention of gastric cancer bleeding
Time frame: Up to 6 years of study period
Transfusion requirement (packed RBC unit)
Unit of packed RBC required at the time of tumor bleeding
Time frame: Up to 6 years of study period
Number of endoscopy to evaluate tumor bleeding
No of endoscopic session to evaluation bleeding from advanced gastric cancer
Time frame: Up to 6 years of study period
Number of endoscopic treatment for cancer bleeding
Total number of endoscopic treatment perfomed for gastric cancer bleeding in each patient
Time frame: Up to 6 years of study period
Overall survival
Time frame: Up to 6 years of study period
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