UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061838 |
|---|---|
| Receipt number | R000070762 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/06/09 |
| Last modified on | 2026/06/09 09:57:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
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
Acronym
ROLM-HR Study
Scientific Title
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
Scientific Title:Acronym
ROLM-HR Study
Region
| Japan |
Condition
Condition
Post-ESD mucosal defects in high-risk patients undergoing gastric endoscopic submucosal dissection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate whether a standardized management strategy using the reopenable-clip over-the-line method (ROLM) can achieve a predefined performance goal for clinically significant delayed bleeding within 30 days after gastric endoscopic submucosal dissection in high-risk patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of clinically significant delayed bleeding within 30 days after gastric endoscopic submucosal dissection
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Closure of post-ESD mucosal defects in high-risk patients (BEST-J score >= 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key 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
Key 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
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Department of Gastroenterology
Zip code
5138630
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie
TEL
0593821311
m06076tn@icloud.com
Public contact
Name of contact person
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Department of Gastroenterology
Zip code
5138630
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie
TEL
0593821311
Homepage URL
m06076tn@icloud.com
Sponsor or person
Institute
Suzuka General Hospital
Institute
Department
Personal name
Funding Source
Organization
None / Self-funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board Office, Suzuka Central General Hospital
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie
Tel
0593821311
m06076tn@icloud.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鈴鹿中央総合病院（三重県），伊勢赤十字病院（三重県），市立四日市病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070762
