UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042497 |
|---|---|
| Receipt number | R000048500 |
| Scientific Title | New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure |
| Date of disclosure of the study information | 2020/11/20 |
| Last modified on | 2022/11/25 21:53:33 |
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Basic information
Public title
New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Acronym
New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Scientific Title
New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Scientific Title:Acronym
New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Region
| Japan |
Condition
Condition
rectal neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate a preventive effect of endoscopic ligation with O-ring closure for delayed complications after rectal endoscopic submucosal dessection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the bleeding rate after rectal endoscopic submucosal dissection
Key secondary outcomes
1)complete closure rate
2)delayed perforation rate
3)total closure time
4)Wound separation rate
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
To perform endoscopic ligation with O-ring closure for an artificial defect after rectal endoscopic submucosal dissection
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
The patients that needed rectal endoscopic submucosal dissection like below
1)a tumor that en bloc resection is difficult by endoscopic mucosal resection like below
LST-NG, especially pseudo-depressed type, the lesion that has a type of Vi pit pattern, shallow submucosal invasion, a large elevated lesion suspected cancer,
2)an intramural tumor with fibrosis of submucosal layer
3)a tumor caused by chronic inflammation such as ulcerative colitis
4)a residual tumor after endoscopic resection
Key exclusion criteria
a rectal tumor extending to anal canal over 10% of all
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Tada |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
TEL
087-891-2156
n-tada@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Tada |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
TEL
087-891-2156
Homepage URL
n-tada@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
Tel
087-891-2156
n-tada@med.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
| 2020 | Year | 11 | Month | 20 | 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
32
Results
Complete closure of the defect (median defect size 29.0 mm) was successfully achieved in 24 cases (80%). Delayed bleeding occurred in one case with incomplete closure (3.3%). The median ELOC procedure time was 25.5 minutes (interquartile range, 20.0 to 30.0 minutes). The sustained closure rates were 83.3% (20/24) on POD 3 in the 24 cases with complete closure.
Results date posted
| 2022 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (years), median (IQR) 71 (62.7 to 76)
Sex (male), n (%) 13 (43.3)
Lesion site, n (%)
Upper rectum 5(16.7)
Middle rectum 6(20)
Lower rectum 19 (63.3)
Morphology, n (%)
LST-NG 3 (10)
LST-G 11(36.7)
IIa 2 (6.7)
IIa+IIc 1 (3.3)
Is, Isp 5 (16.6)
Submucosal tumor like protrusion 8 (26.7)
Histology, n (%)
Tubular adenoma 9 (30)
Sessile serrated lesion 1 (0.3)
Tubular adenocarcinoma 12 (40)
Tis/T1a 6 (50)
T1b 6 (50)
Lymphovascular invasion 3 (25)
Neuroendocrine tumor 8 (26.7)
G1 7(87.5)
G2 1(12.5)
Lymphovascular invasion 8 (100)
Use of antithrombotic agents, n (%) 4 (13.3)
Participant flow
Adverse events
No ELOC associated complications occurred.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048500
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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