UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050828 |
|---|---|
| Receipt number | R000057925 |
| Scientific Title | A retrospective study to investigate the efficacy and safety of cutting with high-frequency hemostatic forceps in endoscopic submucosal dissection of gastrointestinal tumors |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2023/04/12 20:57:48 |
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Basic information
Public title
A Retrospective Study to Investigate the Efficacy and Safety of Hemostatic Forceps Cutting in Endoscopic Treatment of Gastrointestinal Tumors
Acronym
Efficacy and Safety of Hemostatic Forceps in Endoscopic Therapy
Scientific Title
A retrospective study to investigate the efficacy and safety of cutting with high-frequency hemostatic forceps in endoscopic submucosal dissection of gastrointestinal tumors
Scientific Title:Acronym
Efficacy and Safety of Cutting with Hemostatic Forceps in ESD
Region
| Japan |
Condition
Condition
Gastrointestinal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study will evaluate the completion rate of endoscopic submucosal dissection (ESD) of gastrointestinal tumors, including the use of high-frequency hemostatic forceps to remove blood vessels and fibrosis, as well as the use of additional devices and the presence or absence of damage to resected tissue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ESD completion rate with use of high-frequency hemostatic forceps,Presence of serious complications
Key secondary outcomes
Reasons for using high-frequency hemostats
Probability of tissue damage
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be considered
1) Patients undergoing ESD for gastrointestinal tumors and early-stage gastrointestinal cancers.
2) Tissue resection using high-frequency hemostatic forceps is performed during the procedure in 1).
3) Pathological examination of excised lesions is performed.
4) All necessary data collection items are recorded in the electronic medical record.
Key exclusion criteria
A case of difficult ESD in which a scissors knife was planned to be used preoperatively
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Matsui |
Organization
Kagawa University
Division name
Gastroenterology and Neurology
Zip code
7610793
Address
1750-1 Ikedo, Miki-machi, Kida-gun, Kagawa
TEL
087-891-2156
matsui.takanori@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Matsui |
Organization
Kagawa University
Division name
Gastroenterology and Neurology
Zip code
7610793
Address
1750-1 Ikedo, Miki-machi, Kida-gun, Kagawa
TEL
087-891-2156
Homepage URL
matsui.takanori@kagawa-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
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
Clinical Research Support Center, Kagawa University Hospital
Address
1750-1 Ikedo, Miki-machi, Kida-gun, Kagawa
Tel
087-898-5111
md-chiken@kagawa-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 31 | 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
40
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
| 2021 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Refer to the endoscopy reports and histopathology results recorded in the electronic medical record to create a list of study subjects. Examine the electronic medical record records for each subject and collect data on observation and measurement items.
Management information
Registered date
| 2023 | Year | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057925
