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A Randomized Controlled Trial on the Effectiveness of Prophylactic Antibiotics in Gastric Endoscopic Submucosal Dissection

A Randomized Controlled Trial on the Effectiveness of Prophylactic Antibiotics in Gastric Endoscopic Submucosal Dissection - Prophylactic Antibiotics in Gastric ESD: RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056976
Enrollment
200
Registered
2025-02-07
Start date
2021-07-12
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

gastric tumor

Interventions

Prophylactic Antibiotic Administration Group Medication used: Ampicillin + Sulbactam (injectable),3g per dose Administration schedule: Intravenous injection three times 1 hour before surgery 8 hou

Sponsors

Gifu University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 20 years or older at registration Diagnosed with gastric cancer and scheduled for endoscopic treatment (endoscopic treatment eligibility according to the gastric cancer guidelines) Adenomas (size not specified) Other tumor-like lesions (such as neuroendocrine tumors) diagnosed or suspected, and scheduled for ESD

Exclusion criteria

Exclusion criteria: Patients who develop multiple ESD-induced ulcers simultaneously Patients with a gastric tube or post-surgical stomach Patients with an allergy to antibiotics (Ampicillin/Sulbactam) Patients with a history of hypersensitivity to penicillin antibiotics Patients diagnosed with infectious mononucleosis Patients requiring heparinization (oral anticoagulants are acceptable according to the guidelines of the Endoscopic Society) Patients who regularly take analgesics Pregnant patients Patients undergoing maintenance dialysis Patients taking steroid medications Patients with cognitive dysfunction making it difficult to participate in the trial Patients deemed unsuitable for the trial by the physician's judgment

Design outcomes

Primary

MeasureTime frame
Incidence of complications (PPS, pneumonia, post-procedural bleeding, delayed perforation) after gastric ESD.

Secondary

MeasureTime frame
Frequency of side effects associated with antibiotic administration (rash, diarrhea, anaphylactic reactions, etc.)

Countries

Japan

Contacts

Public ContactHIROKI TANIGUCHI

Gifu University Hospital Department of Gastroenterology

th_newword@yaoo.co.jp058-230-6000

Outcome results

None listed

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