UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057963 |
|---|---|
| Receipt number | R000065427 |
| Scientific Title | Endoscopic non-coagulation Clipping method After gastric ESD for Prevention of delayed bleeding; Open label randomized controlled trial.(E-CAP trial) |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/05/26 09:42:57 |
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Basic information
Public title
Endoscopic non-coagulation Clipping method After gastric ESD for Prevention of delayed bleeding; Open label randomized controlled trial.(E-CAP trial)
Acronym
E-CAP trial
Scientific Title
Endoscopic non-coagulation Clipping method After gastric ESD for Prevention of delayed bleeding; Open label randomized controlled trial.(E-CAP trial)
Scientific Title:Acronym
E-CAP trial
Region
| Japan |
Condition
Condition
Gastric cancer, Gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of non-inferiority of non-coagulation clipping to post-ESD coagulation in preventing post-bleeding after gastric ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of delayed bleeding within 14 days after ESD
Key secondary outcomes
Inflammatory findings in blood tests (WBC, CRP) the day after ESD
Rate of occurrence of symptoms (fever and abdominal pain) related to post-electrocoagulation syndrome
Time required for preventive treatment for bleeding
Cost required for preventive treatment for bleeding
Rate of occurrence of other adverse events including delayed perforation within 14 days after ESD
Total length of hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Non-coagulation clipping is performed on the ulcer after ESD to prevent postoperative bleeding.
Interventions/Control_2
Post-electrocoagulation syndrome is performed on the ulcer after ESD to prevent postoperative bleeding.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Patients have been diagnosed with gastric adenoma or early gastric cancer (including suspected cases) in preoperative examinations and are scheduled to undergo ESD.
2 Preoperative endoscopic examination reveals that the tumor is 5cm or less in long diameter.
3 Patients are aged older than 18 years and younger than 90 years at the time of enrollment.
4 Patients have been fully informed about participating in the study and have given their consent.
Key exclusion criteria
1 Cases in which multiple lesions are scheduled to be treated on the same day
2 Cases in which the tumor length exceeds 5 cm
3 Cases in the postoperative stomach
4 Cases in which 14-day follow-up after ESD is not possible
5 Cases that the investigator deems inappropriate
6 Cases in which it is difficult to suspend antithrombotic drugs according to the guidelines
7 Cases in which patients undergoing hemodialysis
8 Cases in which patients with reduced renal function (Cre>2.0mg/mL) or reduced platelet count (PLT<5.0*10^7/mL) in preoperative blood sampling
Target sample size
290
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science
Zip code
602-8566
Address
465 Kajiicho, Kawaramachi-dori Hirokojiagaru, Kamigyo-ku, Kyoto City
TEL
075-251-5111
osamu-d@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science
Zip code
602-8566
Address
465 Kajiicho, Kawaramachi-dori Hirokojiagaru, Kamigyo-ku, Kyoto City
TEL
075-251-5111
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Akasi city hospital, Omihachiman community medical center, Osaka Saiseikai suita hospital, MEDICAL CORPORATION KEISHINKAI Kyoto kidugawa hosipital, Japanese red cross Kyoto daiichi hospital, Saiseikai Shiga hospital, Otsu city hospital, Fukuchiyama city hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajiicho, Kawaramachi-dori Hirokojiagaru, Kamigyo-ku, Kyoto City
Tel
0752515111
rinri@koto.kpu-m.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
| 2025 | Year | 07 | Month | 01 | 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
| 2025 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065427
