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A study to evaluate the safety of early initiation of soft diet after gastric ESD using endoscopic hand-suturing.

A study to evaluate the safety of early initiation of soft diet after gastric ESD using endoscopic hand-suturing. - The safety of early initiation of soft diet after gastric ESD using endoscopic hand-suturing.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054827
Enrollment
25
Registered
2024-07-02
Start date
2024-07-02
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 gastric cancer

Interventions

Sponsors

Sapporo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Scheduled to undergo ESD for early gastric cancer with a diameter of 3 cm or less 2. Age at enrollment is 20 years or older 3. Performance status is 0 to 1 according to ECOG criteria 4. Patients from whom we have not obtained written informed consent for participation in the study

Exclusion criteria

Exclusion criteria: 1) Patients with hemorrhagic diathesis if any of the following applies, Platelet count is less than 50,000/mm3 or PT-INR is 2 or higher with no anticoagulants Patients with liver cirrhosis fall under B-C in the Child-Pugh score. Patients with chronic renal failure on maintenance dialysis 2) Patients who can not be withdrawn from antithrombotic medications according to the JGES guidelines 3) Patients with lesions for which EHS is difficult due to site/technical difficulty 4) Patients with a history of surgical gastrectomy excluding partial resection 5) Patients who can not give consent for this study

Design outcomes

Primary

MeasureTime frame
The rate of complications (delayed bleeding/ perforation) within 28 days in the group that started a solid diet early after ESD plus endoscopic hand-suturing.

Secondary

MeasureTime frame
The rate of successfulness of EHS procedures The rate of incidence of ESD-related symptoms (nausea, abdominal pain, etc.) The suture retention rate at 1 week/day after ESD Nutritional status at 1 week after ESD

Countries

Japan

Contacts

Public ContactTsukasa Yamakawa

Sapporo Medical University Gastroenterology and Hepatology

awakamay.dem1@gmail.com0116112111

Outcome results

None listed

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