Skip to content

A Single-Center Randomized Controlled Study on the Effect of Preoperative Helicobacter pylori Eradication on Intraoperative Bleeding During Endoscopic Submucosal Dissection for Early Gastric Cancer

A Single-Center Randomized Controlled Study on the Effect of Preoperative Helicobacter pylori Eradication on Intraoperative Bleeding During Endoscopic Submucosal Dissection for Early Gastric Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109061
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Early gastric cancer

Interventions

Control group:Standard Helicobacter pylori eradication therapy is administered after ESD.
Preoperative Eradication Group:Standard Helicobacter pylori eradication therapy is administered prior to ESD.

Sponsors

Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University, Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 75 years, no gender restrictions; 2. Endoscopically/biopsy-confirmed early gastric cancer lesions; 3. Meets absolute or expanded ESD indications according to the Japanese Society of Gastrointestinal Endoscopy Guidelines (2nd Edition); 4. Positive result in at least one of the following tests: ¹³C-urea breath test, Hp fecal antigen test, or rapid urease test; 5. Voluntarily participates in this study and signs the relevant informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of Hp eradication therapy within the past 3 months prior to recruitment; 2. History of gastric surgery; 3. Drug allergy or intolerance to Hp eradication therapy; 4. Pregnancy or lactation; 5. Contraindications for ESD-related procedures; 6. Preoperative use of anticoagulants other than aspirin, including warfarin, direct oral anticoagulants, P2Y12 receptor antagonists, or phosphodiesterase-3 inhibitors; 7. Participation in other clinical trials within the past 3 months or ongoing participation in other trials; 8. Other conditions deemed unsuitable for study participation at the investigator's discretion;

Design outcomes

Primary

MeasureTime frame
intraoperative bleeding;

Secondary

MeasureTime frame
intraoperative perforation;lesion detection rate;delayed postoperative bleeding;operative time;postoperative hospital stay;treatment cost;

Countries

China

Contacts

Public ContactWei Zhang

Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University, Medical School

kimmysai@126.com+86 181 3685 9899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026