UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023107 |
|---|---|
| Receipt number | R000026632 |
| Scientific Title | Efficacy of line-assisted complete closure of large colorectal mucosal defects after endoscopic submucosal dissection: a randomized controlled trial |
| Date of disclosure of the study information | 2016/07/13 |
| Last modified on | 2021/07/15 09:19:10 |
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Basic information
Public title
Efficacy of line-assisted complete closure of large colorectal mucosal defects after endoscopic submucosal dissection: a randomized controlled trial
Acronym
LACC trial
Scientific Title
Efficacy of line-assisted complete closure of large colorectal mucosal defects after endoscopic submucosal dissection: a randomized controlled trial
Scientific Title:Acronym
LACC trial
Region
| Japan |
Condition
Condition
colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether line-assisted complete closure (LACC) of a large colorectal mucosal defect after endoscopic submucosal dissection can reduce post-ESD coagulation syndrome or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Proportion of post-ESD coagulation syndrome
Key secondary outcomes
Proportion of delayed perforation
Proportion of delayed bleeding
Success rate of LACC
Procedure time of LACC
Length of hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Non-closure group
Interventions/Control_2
Line-assisted complete closure group
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
Female
Key inclusion criteria
Women
Lesions are located at the Cecum or Ascending colon
Large mucosal defect after colonic ESD
Key exclusion criteria
Lesions invaded at the appendiceal orifice or ileocecal valve
Patients with intra-operative perforation
Patients with severe organ failure
Patients who have been judged as in appropriate for this study
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Takeuchi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
takeuti-yo@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Yamasaki |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
Homepage URL
yamazaki-ya@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases, Department of Gastrointestinal Oncology
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
Address
Tel
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
| 2016 | Year | 07 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2023 | 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
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2021 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026632
