UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062186 |
|---|---|
| Receipt number | R000071006 |
| Scientific Title | A multicenter, prospective, randomized controlled trial to evaluate the efficacy and safety of underwater endoscopic submucosal resection with ligation device (U-ESMRL) for rectal neuroendocrine tumors. |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/01 20:47:47 |
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Basic information
Public title
The efficacy and safety of Underwater ESMRL for rectal NET
Acronym
The efficacy and safety of Underwater ESMRL for rectal NET (U-ESMRL study)
Scientific Title
A multicenter, prospective, randomized controlled trial to evaluate the efficacy and safety of underwater endoscopic submucosal resection with ligation device (U-ESMRL) for rectal neuroendocrine tumors.
Scientific Title:Acronym
A multicenter, prospective, randomized controlled trial to evaluate the efficacy and safety of underwater endoscopic submucosal resection with ligation device (U-ESMRL) for rectal neuroendocrine tumors. (U-ESMRL study)
Region
| Japan |
Condition
Condition
Rectal neuroendocrine tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of underwater ESMRL for rectal NET
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sufficient vertical complete(R0) resection (SVR0)
Key secondary outcomes
The clinical complete(R0) resection
The histological complete(R0) resection
Muscle layer resection
Vertical margin distance
Tumor depth
Adverse event
Procedure time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Underwater ESMRL
Interventions/Control_2
Conventional ESMRL with injection
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are 18 years of age or older at the time of obtaining consent
(2) A person for whom the patient's written consent has been obtained
(3) histologic or endoscopic diagnosis of rectal NET
(4) Lesions located at the rectal Ra or Rb
(5) Tumor size less than or equal to 10mm
Key exclusion criteria
(1) Tumor invasion into the muscularis propria
(2) Lymph nodes or distant metastasis
(3) Patients who are deemed unsuitable as research subjects by the principal investigator or sub-researcher
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Kinugasa |
Organization
Okayama university hospital
Division name
Gastroenterology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357219
hkinugasa14@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yamamoto |
Organization
Okayama university hospital
Division name
Gastroenterology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357219
Homepage URL
pqm79e6u@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
Funding Source
Organization
Okayama university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama university hospital
Address
2-5-1 Shikata-cho, kita-ku, Okayama
Tel
0862357219
pqm79e6u@s.okayama-u.ac.jp
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
岡山大学病院（岡山県）、岡山済生会総合病院（岡山県）、岡山市立市民病院（岡山県）、岡山赤十字病院（岡山県）、岡山労災病院（岡山県）、岡山協立病院（岡山県）、倉敷中央病院（岡山県）、津山中央病院（岡山県）、広島市民病院（広島県）、福山市民病院（広島県）、岩国医療センター（山口県）、姫路赤十字病院（兵庫県）、香川県立中央病院（香川県）、三豊総合病院（香川県）、住友別子病院（愛媛県）、一宮西病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 28 | 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 | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 12 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2026 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071006
