UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057368 |
|---|---|
| Receipt number | R000065557 |
| Scientific Title | Usefulness of two-stage endoscopic resection (TSER) for superficial non-ampullary duodenal epithelial tumor (SNADET) |
| Date of disclosure of the study information | 2025/03/25 |
| Last modified on | 2026/01/21 23:25:36 |
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Basic information
Public title
Usefulness of two-stage endoscopic resection (TSER) for superficial non-ampullary duodenal epithelial tumor (SNADET)
Acronym
Usefulness of two-stage endoscopic resection (TSER) for superficial non-ampullary duodenal epithelial tumor (SNADET)
Scientific Title
Usefulness of two-stage endoscopic resection (TSER) for superficial non-ampullary duodenal epithelial tumor (SNADET)
Scientific Title:Acronym
Usefulness of two-stage endoscopic resection (TSER) for superficial non-ampullary duodenal epithelial tumor (SNADET)
Region
| Japan |
Condition
Condition
superficial non-ampullary duodenal epithelial tumor; SNADET
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of two-stage endoscopic resection for large protruding SNADETs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Procedure time
Adverse event
Length of hospital stay
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
two-stage endoscopic resection
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of large, raised SNADETs that occupy the lumen and do not allow space for manipulation during preoperative endoscopy. Patients who have given written consent to participate in the clinical study.
Key exclusion criteria
1) Endoscopically diagnosed cases with submucosal invasion
2) Local remnants after endoscopic resection, postoperative anastomotic lesions
3) Cases of familial colorectal adenomatosis
4) Cases with serious complications that do not tolerate general anesthesia
5) Women of childbearing potential, pregnant, or lactating women
6) Other cases in which participation in the study is deemed inappropriate by the physician in charge
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ohata |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-3448-6111
ken.ohata1974@gmail.com
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Takeuchi |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-3448-6111
Homepage URL
naotakeuchi0222@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
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
NTT Medical Center Tokyo Ethics Committee
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-3448-6111
naotakeuchi0222@gmail.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
NTT東日本関東病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065557
