UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047953 |
|---|---|
| Receipt number | R000054670 |
| Scientific Title | A prospective study investigating the efficacy and safety of traction-band-assisted endoscopic closure for mucosal defect after colorectal endoscopic submucosal dissection: A multi-center trial (TBEC Trial) |
| Date of disclosure of the study information | 2022/06/05 |
| Last modified on | 2025/06/09 03:20:24 |
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Basic information
Public title
A prospective study investigating the efficacy and safety of traction-band-assisted endoscopic closure for mucosal defect after colorectal endoscopic submucosal dissection: A multi-center trial (TBEC Trial)
Acronym
TBEC Trial
Scientific Title
A prospective study investigating the efficacy and safety of traction-band-assisted endoscopic closure for mucosal defect after colorectal endoscopic submucosal dissection: A multi-center trial (TBEC Trial)
Scientific Title:Acronym
TBEC Trial
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficaty of traction band for endoscopic closure of mucosal defect after colorectal endoscopic submucosal dissection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete closure of mucosal defect
Key secondary outcomes
The number of traction device and clip required, closure time, ESD procedure time, en bloc resection, complete resection, curative resection, adverse events
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
Traction-band-assisted endoscopic closure (TBEC) for mucosal defect after colorectal ESD
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Presence of colorectal neoplasms with 20-50mm in size diagnosed by endoscopy and capable of undergoing ESD as a local treatment
(2)Lesions diagnosed as colorectal adenomas or adenocarcinomas (cT1a)
(3)20 years old or more
(4)Performance Status: 0, 1, 2
(5)Informed consent is obtained
Key exclusion criteria
(1)Lesions spreading to the Bauhin bulb or appendix
(2)Lesions spreading to the diverticulum
(3)Lesions located at the lower rectum
(4)Currently undergoing dialysis
(5)Requiring continuous administration of heparin during the perioperative period.
(6)Patients taking steroids or immunosuppressive drugs
(7)Those with contraindications for endoscopy
(8)Patients judged to be inappropriate for the study by the attending physician in this trial
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yorinobu |
| Middle name | |
| Last name | Sumida |
Organization
Kitakyushu Municipal Medical Center
Division name
Department of Gastroenterology
Zip code
802-8561
Address
2-1-1, Bashaku, Kokura-kitaku, Kitakyushu
TEL
0935411831
y.raisin@gmail.com
Public contact
Name of contact person
| 1st name | Yorinobu |
| Middle name | |
| Last name | Sumida |
Organization
Kitakyushu Municipal Medical Center
Division name
Department of Gastroenterology
Zip code
802-8561
Address
2-1-1, Bashaku, Kokura-kitaku, Kitakyushu
TEL
0935411831
Homepage URL
y.raisin@gmail.com
Sponsor or person
Institute
Kitakyushu Municipal Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kitakyushu City Hospita Organization
Address
1-35, Kofunabemachi, Kokurakita-ku, Kitakyushu City
Tel
093-533-5615
kcho-kenkyu01@kitakyu-cho.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
| 2022 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-2591-7104
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-2591-7104
Number of participants that the trial has enrolled
34
Results
A total of 34 patients with colorectal neoplasms measuring 20-50 mm scheduled for ESD were enrolled. TBEC was performed at each mucosal defect after ESD. TBEC yielded a 100% (95%CI 89.8%-100%) complete closure rate, with a median (interquartile range [IQR]) closure time of 14.5 (12.9) minutes. The median (IQR) number of clips used was 10 (3.3). One case of delayed bleeding and one of post-ESD coagulation syndrome (both 2.9% [95%CI 0.5%-14.9%]) occurred following TBEC.
Results date posted
| 2025 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 80 patients underwent colorectal ESD from June 2022 to March 2023, of whom34were finally enrolled.
Moreover, the safety analysis, full analysis, and per-protocol set seach consisted of all 34 patients.
The median (IQR) tumor diameter was 29.0 (10.3) mm.
Participant flow
This multicenter prospective single-arm pilot study was conducted at three institutions from June 2022 to March 2023. A total of 34 patients with colorectal neoplasms measuring 20-50 mm scheduled for ESD were enrolled. TBEC was performed at each mucosal defect after ESD.
Adverse events
One case of delayed bleeding and one of post-ESD coagulation syndrome occurred following TBEC.
Outcome measures
The primary outcome was the complete closure rate by TBEC. Secondary outcomes included the number of clips used, procedure time, and adverse events (AEs).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054670
