UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050404 |
|---|---|
| Receipt number | R000057381 |
| Scientific Title | Safety and efficacy of near-infrared fluorescent clip tumor site marking in robot-assisted laparoscopic gastrectomy. |
| Date of disclosure of the study information | 2023/02/21 |
| Last modified on | 2023/02/21 19:04:13 |
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Basic information
Public title
Safety and efficacy of near-infrared fluorescent clip tumor site marking in robot-assisted laparoscopic gastrectomy.
Acronym
Safety and efficacy of near-infrared fluorescent clip tumor site marking in robot-assisted laparoscopic gastrectomy.
Scientific Title
Safety and efficacy of near-infrared fluorescent clip tumor site marking in robot-assisted laparoscopic gastrectomy.
Scientific Title:Acronym
Safety and efficacy of near-infrared fluorescent clip tumor site marking in robot-assisted laparoscopic gastrectomy.
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our study demonstrates that preoperative placement of a near-infrared fluorescent clip in the gastric mucosa, followed by intraoperative observation with a fluorescent camera from the gastric serosa, is a safe and effective method for marking the gastric resection line during laparoscopic and robot-assisted gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the percentage of cases in which fluorescent clips are successfully identified.
Key secondary outcomes
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
Inclusion criteria for this study are as follows: histologically diagnosed gastric cancer, clinical diagnosis of T1-2N0-3M0 or T3-4N0M0, lesion not indicated for endoscopic submucosal dissection or total gastrectomy, and patient's full understanding and written consent to participate in the study.
Key exclusion criteria
Exclusion criteria for this study are as follows: patients with a history of gastrectomy, those who have undergone preoperative chemotherapy, and those deemed inappropriate to participate in the study by the attending physician.
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 | Hiroki |
| Middle name | |
| Last name | Ishida |
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
hiroki.ishida@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
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
hiroki.ishida@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 21 | 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
| 2021 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The day before the surgery, an upper gastrointestinal endoscopy should be performed to place a marking clip. This procedure is the same as what is done in routine clinical practices. For those undergoing distal gastrectomy, one fluorescent clip should be placed on the mucosa proximal to the lesion. For patients undergoing proximal gastrectomy, one should be placed on the mucosa distal to the lesion. For those undergoing pyloric preserving gastrectomy, one should be placed on the mucosa both proximal and distal to the lesion.
Management information
Registered date
| 2023 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057381
