UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053415 |
|---|---|
| Receipt number | R000060965 |
| Scientific Title | Efficacy and Safety of Endoscopic Tumor Resection Applying Pre-Removal Drawstring Suture for Gastrointestinal Tumors |
| Date of disclosure of the study information | 2024/01/23 |
| Last modified on | 2024/01/23 14:20:07 |
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Basic information
Public title
Efficacy and Safety of Endoscopic Tumor Resection Applying Pre-Removal Drawstring Suture for Gastrointestinal Tumors
Acronym
ESR study
Scientific Title
Efficacy and Safety of Endoscopic Tumor Resection Applying Pre-Removal Drawstring Suture for Gastrointestinal Tumors
Scientific Title:Acronym
ESR study
Region
| Japan |
Condition
Condition
gastrointestinal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are widely used in the treatment of gastrointestinal tumors. Although advances in technology and equipment have improved the safety of treatment, there are still challenging cases, and bleeding, perforation, and other complications have been observed. In recent years, the development of a needle holder for use with a flexible endoscope has made it possible to suture endoscopically, and manual suturing of the ulcer bottom after ESD has become possible for the purpose of preventing accidents, and the usefulness of this technique has been reported. In this study, we focused on the use of a width suture and devised a method that has advantages both during and after resection by suturing around the lesion before resection, and we will examine the usefulness and safety of this treatment method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment Completion Rate
Key secondary outcomes
Treatment time, batch resection rate, local fluid usage, suture retention rate, and frequency of incidentalities
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
For gastrointestinal tumors for which endoscopic submucosal dissection is indicated, we have developed a procedure in which the surrounding area is sutured prior to 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
Eligible patients must be patients who are eligible for insurance coverage of endoscopic submucosal dissection between May 2023 and May 2024, and who have received a full explanation of their participation in this study, and who have given their free and voluntary consent to the new method of treatment based on full understanding of the patient's needs.
Key exclusion criteria
Exclusion criteria include suspected disseminated intravascular coagulation syndrome, severe heart failure, active thromboembolism at the time of study entry, severe respiratory failure, pregnancy or women of childbearing potential, and other subjects deemed unsuitable by the study investigator (subinvestigator).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki harbor medical center
Division name
gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
taku.okamu1002@gmail.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki Harbor Medical Center
Division name
gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
Homepage URL
taku.okamu1002@gmail.com
Sponsor or person
Institute
Nagasaki harbor 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
Nagasaki Minato Medical Center Research and Development Center
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
Tel
0958223251
kenkyu@ncho.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 23 | 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
13
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060965
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
