Evaluation of clinical usefulness of proton pump inhibitor after endoscopic mucosal resection or endoscopic submucosal dissection for esophageal cancer: A multicenter prospective randomized controlled trial

Evaluation of clinical usefulness of proton pump inhibitor after endoscopic mucosal resection or endoscopic submucosal dissection for esophageal cancer: A multicenter prospective randomized controlled trial - PPI after EMR/ESD for esophageal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002544

Enrollment

220

Registered

2009-09-28

Start date

2010-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early esophageal cancer

Interventions

PPI medicated group, in whom PPI is given after endoscopic esophageal mucosal resection or endoscopic submucosal dissection non PPI medicated group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who will be performed endoscopic treatment for esophageal cancer. 2. Absolute or relative indication of endoscopic treatment within the therapy guidelines for esophageal cancer. 3. Patients who have no risk of esophageal stricture after endoscopic treatment, e.g, the lesion is less than 5 cm of the longitudinal length or smaller than 3/4 of the circumference. 4. Patients with no prior chemotherapy, radiotherapy and surgical treatment for esophageal cancer. 5. Total score of FSSG is equal or lower than seven before endoscopic treatment. 6. Patients without apparent gastroesophageal reflux disease in endoscopy. 7. Patients without medication of PPI and H2 receptor antagonist. 8. Patients without history of radiotherapy for neck, chest, and upper abdominal region. 9. ECOG-Performance Status is zero or one. 10. Adult patients aged upper 20 years old. 11. Patient who can answer FSSG and VAS about his certain symptom. 12. Patients with adequate liver and renal function. Laboratory data obtained within 4 weeks of enrollment must be as follows; AST(GOT)<100 IU/L, ALT(GPT)<100 IU/L 13. Patients must sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with active peptic ulcer in stomach or duodenum. 2. Patients with active concomitant cancers. 3. Patients requiring systemic steroids medication. 4. Patients with continuous systemic medication of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). 5. Patients who cannot discontinue anticoagulant drug or antiplatelet drug before endoscopic treatment. 6. Patients with severe mental disease or psychotic manifestation. 7.Patients who have been judged as inappropriate for this study for any reasons by the concerning investigators.

Design outcomes

Primary

Measure	Time frame
Rates of GERD symptom	—

Secondary

Measure	Time frame
1) Rates of scar formation at the 5 weeks after endoscopic treatment. 2) Rates of GERD symptom with seven terms according to acid-reflux-related symptoms in FSSG (Frequency Scale for the Symptoms of GERD). 3) Incidence of EMR or ESD associated symptoms of pain 4) Improvement rates of GERD symptoms in those who got started PPI because of GERD symptom in non-PPI medicated group. 5) Adverse events and side effects of PPI medication.	—

Measure

Time frame

1) Rates of scar formation at the 5 weeks after endoscopic treatment. 2) Rates of GERD symptom with seven terms according to acid-reflux-related symptoms in FSSG (Frequency Scale for the Symptoms of GERD). 3) Incidence of EMR or ESD associated symptoms of pain 4) Improvement rates of GERD symptoms in those who got started PPI because of GERD symptom in non-PPI medicated group. 5) Adverse events and side effects of PPI medication.

—

Countries

Japan

Contacts

Public ContactKimiko Hori

Kyoto University Graduate School of Medicine Department of Gastroenterology and Hepatology

075-751-4319

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026