UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021171 |
|---|---|
| Receipt number | R000024412 |
| Scientific Title | Assessment of feasibility of sentinel node mapping by indocyanine green fluorescence imaging and metastatic diagnosis by one-step nucleic acid amplification in laparoscopic gastric cancer surgery |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2023/09/07 16:08:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of feasibility of sentinel node mapping by indocyanine green fluorescence imaging and metastatic diagnosis by one-step nucleic acid amplification in laparoscopic gastric cancer surgery
Acronym
Assessment of validity of sentinel node mapping by indocyanine green fluorescence imaging in laparoscopic gastric cancer surgery
Scientific Title
Assessment of feasibility of sentinel node mapping by indocyanine green fluorescence imaging and metastatic diagnosis by one-step nucleic acid amplification in laparoscopic gastric cancer surgery
Scientific Title:Acronym
Assessment of validity of sentinel node mapping by indocyanine green fluorescence imaging in laparoscopic gastric cancer surgery
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the clinical availability of the combination of the sentinel node detection by indocyanine green fluorescence imaging and the metastatic diagnosis by one-step nucleic acid amplification in laparoscopic gastric cancer surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
identification rate of fluorescent nodes
Key secondary outcomes
1)Durations of tracer administration, sentinel node mapping and diagnosis by one-step nucleic acid amplification.
2)Number of detected sentinel nodes
3)Distribution of sentinel nodes
4)Incidence rate of adverse events and postoperative complications
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
To detect sentinel nodes, the tracer (indocyanine green solution) is administrated to the submucosa around the primary tumor at the beginning of surgery.
Stained/fluorescent nodes are harvested intracorporeally prior to gastrectomy. Study subjects will be performed gastrectomy according to gastric cancer treatment guideline.
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) age >= 20
2) clinically T1N0M0 gastric cancer
3) single lesion
4) less than 4cm in diameter
5) out of indication for endoscopic resection
6) biopsy from the primary lesion is positive for CK19
7) BMI <=25
8) The patient who give prior concent to join this study
9) the type of biopsy specimen does not matter
Key exclusion criteria
1) the past history of gastric resection or the endoscope treatment
2) the case with tumor invading to esophagus or duodenum
3) a pregnant woman, patients having drug (iodo) allergy career or the asthma
4) the case which the physician judged as the inappropriate case to participate in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Souya |
| Middle name | |
| Last name | Nunobe |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Gastroenterological surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
souya.nunobe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Koshi |
| Middle name | |
| Last name | Kumagai |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Gastroenterological surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
Homepage URL
koshi.kumagai@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
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
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
Tel
03-3520-0111
med.shinsa@jfcr.or.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
公益財団法人 がん研究会有明病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 25 | 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 | 07 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | 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 | 02 | Month | 24 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024412
