Prospective multicenter single-arm study evaluating the efficacy of a standardized management strategy using the reopenable-clip over-the-line method (ROLM) for mucosal defects after gastric endoscopic submucosal dissection in high-risk patients

Prospective multicenter single-arm study evaluating the efficacy of a standardized management strategy using the reopenable-clip over-the-line method (ROLM) for mucosal defects after gastric endoscopic submucosal dissection in high-risk patients - ROLM-HR Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061838

Enrollment

Registered

2026-06-09

Start date

2026-06-10

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

Post-ESD mucosal defects in high-risk patients undergoing gastric endoscopic submucosal dissection

Interventions

Closure of post-ESD mucosal defects in high-risk patients (BEST-J score &gt

= 3). After gastric ESD, all patients undergo defect closure using the reopenable-clip over-the-line method (ROLM). Perioperative management is performed according to the predefined study protocol.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 20 years or older at the time of informed consent 2. Patients undergoing gastric endoscopic submucosal dissection (ESD) for gastric neoplasms 3. Patients with post-ESD mucosal defects considered amenable to closure using the reopenable-clip over-the-line method (ROLM) 4. BEST-J score >= 3 5. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Lesions involving the cardia or pylorus where ROLM is considered technically difficult 2. Mucosal defects involving more than 50% of the gastric circumference 3. Severe fibrosis or poor general condition preventing completion of the study procedure 4. Cases requiring emergency surgery, such as perforation requiring immediate lifesaving treatment 5. Pregnant women or women with possible pregnancy 6. Any patient considered unsuitable for study participation by the principal investigator

Design outcomes

Primary

Measure	Time frame
Incidence of clinically significant delayed bleeding within 30 days after gastric endoscopic submucosal dissection	—

Secondary

Measure	Time frame
1. Technical success rate of ROLM 2. Complete closure rate immediately after the procedure 3. Delayed perforation rate 4. Re-endoscopy rate 5. Blood transfusion rate 6. Readmission rate 7. Length of hospital stay 8. ROLM procedure time 9. Number of clips used 10. Clip dropout rate 11. Adverse event rate 12. Additional bleeding-related healthcare resource utilization 13. Exploratory healthcare cost assessment	—

Measure

Time frame

1. Technical success rate of ROLM 2. Complete closure rate immediately after the procedure 3. Delayed perforation rate 4. Re-endoscopy rate 5. Blood transfusion rate 6. Readmission rate 7. Length of hospital stay 8. ROLM procedure time 9. Number of clips used 10. Clip dropout rate 11. Adverse event rate 12. Additional bleeding-related healthcare resource utilization 13. Exploratory healthcare cost assessment

—

Countries

Japan

Contacts

Public ContactTatsuma Nomura

Suzuka General Hospital Department of Gastroenterology

m06076tn@icloud.com0593821311

Outcome results

None listed

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