UMIN-CTR Clinical Trial

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
Email	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
Email	hisashi.hara@oici.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Osaka International Cancer Institute
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053443