UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research of the laparoscopy endoscopy cooperative colorectal wedge resection (LECS-CR)
Title of the study (Brief title)	Clinical research of the Colorectal LECS
Region	Japan

Condition
Condition	colorectal submucosal tumor, colorectal adenoma, colorectal mucosal adenocarcinoma
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect and feasibility
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of anastomotic leakage
Key secondary outcomes	Operation time, Estimated blood loss, Postoperative hospital stay, Postoperative diet starting day, Postoperative bowel movement starting day, CRP at 1POD, Resection margin positive 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	Operation(laparoscopy/Endoscopy)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Systemic condition is good and tolerable for general anesthesia. 2)Cases which are expected high risk of perforation following to endoscopic mucosal resection because of local recurrence after prior endoscopic treatment or surrounding diverticles, etc.
Key exclusion criteria	1) PS(ECOG)>3 2) Cases which are expected abdominal adhesion after prior abdominal operation 3) Cases which have prior chemotherapy or radiation to the target lesion 4) Cases which have difficuty of understanding of the trial because of mental disease 5) Cases which are judged as not suitable for clinical research by a physician in attendance.
Target sample size	5

Research contact person
Name of lead principal investigator	Yosuke Fukunaga
Organization	Cancer Institute Hospital
Division name	Division of Gastroenterological Surgery and Division of Gastroenterology
Address	3-8-31, Ariake, Kotoku, Tokyo
TEL	03-3520-0111
Email	yosuke.fukunaga@jfcr.or.jp

Public contact
Name of contact person	Yosuke Fukunaga
Organization	Cancer Institute Hospital
Division name	Division of Gastroenterological Surgery
Address	3-8-31, Ariake, Kotoku, Tokyo
TEL	03-3520-0111
Homepage URL
Email	yosuke.fukunaga@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital Divisiion of Gastroenterological Surgery and Division of Gastroenterology
Institute
Department

Funding Source
Organization	No Source
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 05 Month 12 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 04 Month 16 Day
Anticipated trial start date	2015 Year 05 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 11 Day
Last modified on	2018 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020285