UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026937 |
|---|---|
| Receipt number | R000030157 |
| Scientific Title | A clinical role of staging laparoscopy with contrast-enhanced intraoperative ultrasonography and indocyanine green fluorescent imaging for pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2017/04/12 |
| Last modified on | 2021/01/08 16:58:57 |
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Basic information
Public title
A clinical role of staging laparoscopy with contrast-enhanced intraoperative ultrasonography and indocyanine green fluorescent imaging for pancreatic ductal adenocarcinoma
Acronym
SLING trial
Scientific Title
A clinical role of staging laparoscopy with contrast-enhanced intraoperative ultrasonography and indocyanine green fluorescent imaging for pancreatic ductal adenocarcinoma
Scientific Title:Acronym
SLING trial
Region
| Japan |
Condition
Condition
pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of staging laparoscopy with contrast-enhanced intraopeartive ultrasonography and indocyanine green fluorescent imaging for pancreatic ductal adenocarcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of distant organ metastasis
Key secondary outcomes
Comparison of survival rate according to the presence or absence of distant organ metastasis;
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Staging laparoscopy with indocyanine green fluorescent imaging and contrast-enhanced intraoperative ultrasonography for diagnosing occult distant organ metastasis
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
Pancreatic ductal adenocarcinoma patients with CA19-9>300U/ml and tumor size>30mm
Key exclusion criteria
Patients with allagy for iodeine or indocyanine green.
Cirrehosis patients with ICGR15>40.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Saiura |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Hepatobiliary Pancreatic Surgery
Zip code
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
akio.saiura@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Oba |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Hepatobiliary Pancreatic Surgery
Zip code
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
Homepage URL
atsushi.oba@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2017 | Year | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 27 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2021 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030157
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
