UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021012 |
|---|---|
| Receipt number | R000024248 |
| Scientific Title | Safety and efficacy of endoscopic tattooing using a short-length needle for preoperative localization in colorectal cancer surgery: a prospective study |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2019/10/04 08:50:44 |
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Basic information
Public title
Safety and efficacy of endoscopic tattooing using a short-length needle for preoperative localization in colorectal cancer surgery: a prospective study
Acronym
TATTOO study
Scientific Title
Safety and efficacy of endoscopic tattooing using a short-length needle for preoperative localization in colorectal cancer surgery: a prospective study
Scientific Title:Acronym
TATTOO study
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and efficacy of endoscopic tattooing using a short-length needle for preoperative localization in colorectal cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of visible tattooing during laparoscopic surgery
Key secondary outcomes
1. The proportion of ink spillage during laparoscopic surgery
2. The proportion of visible tattooing during laparoscopic surgery for rectal cancer
3. The proportion of ink spillage during laparoscopic surgery for rectal cancer
4. The proportion of complications during laparoscopic surgery
5. Th proportion of sufficient surgical margins in the resected specimens after laparoscopic surgery
6. The duration between endoscopic tattooing and surgery
7. Comparison of accuracy of preoperative tumor location between by endoscopy and radiography
8. The proportion of visible tattooing by endoscopists' experience
9. The proportion of ink spillage by endoscopists' experience
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed as colorectal cancer after colonoscopy in Shizuoka cancer center
2. Patients indicated for surgical resection
3. Patients older than 20 years
4. Patients accepted the participation for this study after full explanation and understanding of the content s of this study
Key exclusion criteria
1. Patients with a palpable rectal cancer
2. Patients whom investigators regarded as inappropriate for the participation
Target sample size
453
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Imai |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
ke.imai@scchr.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Imai |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
ke.imai@scchr.jp
Sponsor or person
Institute
Shizuoka cancer center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka cancer center
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
Shizuoka cancer center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
ke.imai@scchr.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
| 2016 | Year | 02 | Month | 22 | 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
475
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Design: Prospective observation study
Subjects: All of patients are 1) diagnosed as colorectal cancer, 2) indicated for surgery by colonoscopy at our center, 3) met inclusion criteria
Primary endpoint: the population of patients with visible tattoo during laparoscopic surgery out of total of patients receive laparoscopic colectomy
Secondary endpoints:
1) the population of patients with ink spillage during laparoscopic surgery out of total of patients receive laparoscopic colectomy
2) the population of patients with visible tattoo during laparoscopic surgery for rectal cancer out of total of patients receive laparoscopic colectomy for rectal cancer
3) the population of patients with ink spillage during laparoscopic surgery out of total of patients receive laparoscopic colectomy
4) occurrence of adverse events
5) the population of adequate proximal / distal resection margin
6) time interval between endoscopic tattooing and surgery
Management information
Registered date
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2019 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024248
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| Registered date | File name |
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