UMIN-CTR Clinical Trial

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
Email	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
Email	yamazaki-ya@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases, Department of Gastrointestinal Oncology
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026632