UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046843 |
|---|---|
| Receipt number | R000053443 |
| Scientific Title | Retrospective examination to evaluate the information of pathological and prognosis after treatment of patients. The ancillary study of the trial "sentinel lymph node biopsy using ICG observation method in laparoscopic gastrectomy for gastric cancer and oesophageal gastric junction cancer. |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2022/02/07 02:12:48 |
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Basic information
Public title
Retrospective examination to evaluate the information of pathological and prognosis after treatment of patients.
The ancillary study of the trial "sentinel lymph node biopsy using ICG observation method in laparoscopic gastrectomy for gastric cancer and oesophageal gastric junction cancer.
Acronym
Ancillary study on pathological information and prognosis of patients who have undergone sentinel lymph node biopsy by ICG fluorescence observation method
Scientific Title
Retrospective examination to evaluate the information of pathological and prognosis after treatment of patients.
The ancillary study of the trial "sentinel lymph node biopsy using ICG observation method in laparoscopic gastrectomy for gastric cancer and oesophageal gastric junction cancer.
Scientific Title:Acronym
Ancillary investigation on pathological information and prognosis of patients who have undergone sentinel lymph node biopsy by ICG fluorescence observation method
Region
| Japan |
Condition
Condition
gastric cancer and oesophageal gastric junction cancer.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical and pathological information of the perioperative and long-term period of the patients who enrolled in "feasible study of sentinel lymph node biopsy using ICG fluorescence observation method for gastric and oesophageal gastric junction cancer".
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The detection rate of ICG marking and the rate of negative infiltration to the oesophageal and gastric resection line.
Key secondary outcomes
The adverse events related to ICG injection, the length of proximal margin, the perioperative outcomes, including operating time, estimated blood loss, postoperative mortality, morbidity, and postoperative hospital stay.
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
Patients who enrolled in "feasible study of sentinel lymph node biopsy using ICG fluorescence observation method for gastric and oesophageal gastric junction cancer".
Key exclusion criteria
History of laparotomy, body mass index >=30, Type 4 or 5 gastric cancer, previous or other concomitant cancer, a renal, hepatic, or metabolic disorder, cardiac disease, and a history of gastrectomy.
Target sample size
517
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Omori |
Organization
Osaka International Cancer Institute
Division name
Department of Gastroenterological Surgery
Zip code
5418567
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL
0669451181
oomori-ta@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Hara |
Organization
Osaka International Cancer Institute
Division name
Department of Gastroenterological Surgery
Zip code
5418567
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL
066945118
Homepage URL
hisashi.hara@oici.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Osaka International Cancer Institute
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
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
Tel
0669451181
rinri01@opho.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
| 2022 | Year | 02 | Month | 08 | 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
517
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2022 | Year | 02 | Month | 07 | Day |
Last modified on
| 2022 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053443
