UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052600 |
|---|---|
| Receipt number | R000060023 |
| Scientific Title | Prospective Study on the feasibility of underwater endoscopic mucosal resection in the right lateral decubitus position for superficial non-ampullary duodenal epithelial tumors |
| Date of disclosure of the study information | 2023/10/25 |
| Last modified on | 2023/10/24 18:12:11 |
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Basic information
Public title
Prospective Study on the feasibility of underwater endoscopic mucosal resection in the right lateral decubitus position for superficial non-ampullary duodenal epithelial tumors
Acronym
Prospective Study on the feasibility of underwater endoscopic mucosal resection in the right lateral decubitus position for superficial non-ampullary duodenal epithelial tumors
Scientific Title
Prospective Study on the feasibility of underwater endoscopic mucosal resection in the right lateral decubitus position for superficial non-ampullary duodenal epithelial tumors
Scientific Title:Acronym
Prospective Study on the feasibility of underwater endoscopic mucosal resection in the right lateral decubitus position for superficial non-ampullary duodenal epithelial tumors
Region
| Japan |
Condition
Condition
superficial non-ampullary duodenal epithelial tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
During underwater endoscopic mucosal resection (UEMR) for superficial non-ampullary duodenal epithelial tumors (SNADET), vomiting and aspiration due to outflow of the resected specimen due to gravity and intestinal peristalsis and reflux of water are sometimes problems. To improve this problem, we devised UEMR to be performed in the right lateral decubitus position. In the right lateral decubitus position, the duodenum is in a lower position than in the left lateral decubitus position, which reduces the risk of the resected specimen spilling into the anus and reduces the amount of water injected. We thought that this would reduce the risk of vomiting and aspiration. Therefore, this study aimed to clarify the usefulness of UEMR in the right lateral decubitus position for SNADET.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total procedure time
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who were diagnosed with superficial non-ampullary duodenal epithelial tumor by upper endoscopy and judged to be suitable for underwater endoscopic mucosal resection (regardless of whether or not a biopsy was performed).
Those who have given written consent to participate in the research.
Key exclusion criteria
Persons with a history of surgery on the stomach or duodenum
Persons who are unable to lie on their right side due to joint pain or physical disability
Persons with severe renal dysfunction
Persons with severely impaired cardiac function
Person who is pregnant
Persons judged to be unsuitable by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Shimada |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
TEL
0222521111
t.shimada@openhp.or.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Shimada |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
TEL
0222521111
Homepage URL
t.shimada@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
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
Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
Tel
0222521111
t.shimada@openhp.or.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
仙台市医療センター仙台オープン病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The occurrence of short-term adverse events will be confirmed for 28 days from the date of underwater endoscopic mucosal resection.
Management information
Registered date
| 2023 | Year | 10 | Month | 24 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060023
