UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017503 |
|---|---|
| Receipt number | R000020285 |
| Scientific Title | Clinical research of the laparoscopy endoscopy cooperative colorectal wedge resection (LECS-CR) |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2018/11/13 07:47:22 |
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Basic information
Public title
Clinical research of the laparoscopy endoscopy cooperative colorectal wedge resection (LECS-CR)
Acronym
Clinical research of the Colorectal LECS
Scientific Title
Clinical research of the laparoscopy endoscopy cooperative colorectal wedge resection (LECS-CR)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yosuke Fukunaga |
Organization
Cancer Institute Hospital
Division name
Division of Gastroenterological Surgery and Division of Gastroenterology
Zip code
Address
3-8-31, Ariake, Kotoku, Tokyo
TEL
03-3520-0111
yosuke.fukunaga@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Fukunaga |
Organization
Cancer Institute Hospital
Division name
Division of Gastroenterological Surgery
Zip code
Address
3-8-31, Ariake, Kotoku, Tokyo
TEL
03-3520-0111
Homepage URL
yosuke.fukunaga@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Divisiion of Gastroenterological Surgery and Division of Gastroenterology
Institute
Department
Personal name
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)
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
| 2015 | Year | 05 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020285
