gastric epithelial neoplasms
Conditions
Interventions
Patients will be randomly allocated to either VPZ or PPI group. In the PPI group, esomeprazole 20mg will be administered orally from the day before ESD to 54 days after ESD.
VPZ 20mg will be administe
Sponsors
Nagoya University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gastric adenoma or early gastric cancer. condition of early gastric cancer: 1) 2cm or smaller cT1a, well diff. UL0 2) larger than 2cm, cT1a, well diff.UL0 3) 3cm or smaller, cT1a, well diff. UL1 4) 2cm or smaller, cT1a, undiff. UL0 2. age 20 or older 3. PS=0,1,2 4. Laboratory data: Hb 9g/dl or larger Plt 100,000/mm3 or larger AST, ALT 100 1U/l or less PT-INR 80% or larger 5. Could be followed up for 56 days after ESD. 6. Those who gave written consent.
Exclusion criteria
Exclusion criteria: 1. Those with simultaneous esophageal or duodenal endoscopic treatment. 2. Endoscopic treatment for upper digestive tract within 31 days before ESD. 3. Women with pregnancy, 4. Psychological disorders. 5. Presence of active infectious diseases. 6. Impossible to answer to F-Scale or VAS. 7. Allergy to VPZ or EPZ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of bleeding within 8 weeks after ESD. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of GERD-like symptoms after ESD. 2. Frequency of pain after ESD. 3. Healing of the ulcer at 8 weeks after ESD. 4. Adverse events related to ESD. | — |
Countries
Japan
Contacts
Public ContactNaomi Kakushima
Nagoya University Department of Gastroenterology & Hepatology, Nagoya University Graduate School of Medicine
Outcome results
None listed