UMIN-ICDS Clinical Trial

Public title

Multicenter phase I/II study to evaluate the safety and efficacy of EUREKA alpha-assisted minimally invasive gastrectomy

Acronym

EUREKA alpha-GC Study

Scientific Title

Multicenter phase I/II study to evaluate the safety and efficacy of EUREKA alpha-assisted minimally invasive gastrectomy

Scientific Title:Acronym

EUREKA alpha-GC Study

Region

Japan

Condition

Gastric cancer (cStage IA-IIIC)

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluate the safety and efficacy of minimally invasive gastrectomy assisted by the surgical visual support program "EUREKA-alpha" in a two-phase study design.
In phase I, surgery will be performed using the currently approved version of EUREKA-alpha (ver. 1.0.0), which provides enhanced visualization of loose connective tissue, and the primary objective will be to evaluate its safety.
In phase II, after confirming safety in phase I, a next-generation version of EUREKA-alpha ,scheduled for regulatory approval within the next year and equipped with additional analytical functions for nerves and the pancreas, will be used to assess the efficacy (reduction in the incidence of postoperative complications) and safety associated with the utilization of this information.
Across both phases, secondary objectives include evaluating the effects of EUREKA-alpha on shortening operative time and reducing the surgeons' workload.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Phase I: Incidence of intraoperative adverse events (CTCAE v5.0 Grade>=2)
Phase II: Incidence of postoperative overall complications (Clavien-Dindo classification Grade>=III)

Key secondary outcomes

Phase I
Incidence of postoperative overall complications of Clavien Dindo classification Grade>=III
Incidence of postoperative intra abdominal infectious complications of Clavien Dindo classification Grade>=III (anastomotic leakage, pancreatic fistula, intra abdominal abscess)
Amylase levels in drain fluid at the upper margin of the pancreas on postoperative days 1 and 3
Operation time
Blood loss
Rate of conversion to open surgery
Qualitative assessment by the operating surgeons regarding the workload reduction effect of EUREKAalpha

Phase II
Incidence of postoperative intra abdominal infectious complications of Clavien Dindo classification Grade>=III (anastomotic leakage, pancreatic fistula, intra abdominal abscess)
Incidence of postoperative overall complications of Clavien-Dindo classification Grade>=II
Incidence of postoperative intra abdominal infectious complications of Clavien Dindo classification Grade>=II (anastomotic leakage, pancreatic fistula, intra abdominal abscess)
Incidence of intraoperative adverse events
Amylase levels in drain fluid at the upper margin of the pancreas on postoperative days 1 and 3
Operation time
Blood loss
Rate of conversion to open surgery
Qualitative assessment by the operating surgeons regarding the workload reduction effect of EUREKA alpha

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Minimally invasive gastrectomy assisted by EUREKA-alpha

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Histologically confirmed gastric cancer
(2) Scheduled to undergo laparoscopic or robot assisted gastrectomy
(3) No evidence of distant metastasis and diagnosed as cStage IA-IIIC according to the 15th edition of the Japanese Classification of Gastric Carcinoma (in cases with preoperative chemotherapy, staging is based on post treatment status)
(4) No bulky lymph node metastasis
 Bulky lymph node metastasis is defined as either, Two or more lymph nodes >=1.5 cm in the longest diameter located adjacent to each other around the celiac artery, common hepatic artery, splenic artery, or proper hepatic artery, or anterior to the superior mesenteric vein, or A conglomerate of lymph nodes (single or multiple) forming a mass >=3.0 cm in overall longest diameter.
(5) Considered resectable with R0 resection
(6) Macroscopic type other than type 4
(7) No invasion to adjacent organs
(8) No invasion of the esophagus or duodenum
(9) Not a remnant gastric cancer
(10) Age >=18 years at the time of registration
(11) Performance status (ECOG) of 0 or 1
(12) No history of upper abdominal surgery other than laparoscopic cholecystectomy
(13) No history of abdominal radiotherapy for any malignancy. History of endoscopic treatment (EMR, ESD), chemotherapy, or endocrine therapy is allowed
(14) Laboratory data within 28 days prior to registration (the same weekday within 4 weeks before registration is acceptable) meet all of the following criteria
 1,White blood cell count >=3,000/mm3
 2,Platelet count >=100,000/mm3
 3,Hemoglobin >=8.0 g/dL
 4,Total bilirubin <=2.0 mg/dL
 5,AST <=100 U/L
 6,ALT <=100 U/L
 7,Serum creatinine <=1.5 mg/dL
(15) Written informed consent for participation in this study has been obtained from the patient

Key exclusion criteria

(1) Presence of active double or multiple cancers (including synchronous or metachronous cancers with a disease-free interval of <=5 years).
 However, the following cancers are not regarded as active double/multiple cancers, even if the disease-free interval is less than 5 years, because their 5-year relative survival rates exceed 95%:
  Gastric cancer (adenocarcinoma, intestinal type): Stage 0-I
  Colon cancer (adenocarcinoma): Stage 0-I
  Rectal cancer (adenocarcinoma): Stage 0-I
  Esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma): Stage 0
  Breast cancer (non-invasive ductal or lobular carcinoma): Stage 0
  Breast cancer (invasive ductal or lobular carcinoma, Paget's disease): Stage 0-IIA
  Endometrial cancer (endometrioid or mucinous adenocarcinoma): Stage I
  Prostate cancer (adenocarcinoma): Stage I-II
  Cervical cancer (squamous cell carcinoma): Stage 0
  Thyroid cancer (papillary or follicular carcinoma): Stage I-III
  Renal cell carcinoma (clear cell or chromophobe type): Stage I
 Other carcinoma in situ-equivalent lesions.
 Staging should generally follow the UICC-TNM 7th edition or the corresponding Japanese classification systems.
(2) Presence of an active infection requiring systemic therapy
(3) Fever >=38.0 degree at the time of registration
(4) Psychiatric disease or symptoms that interfere with daily life and make study participation difficult
(5) Continuous systemic administration (oral or intravenous) of corticosteroids or other immunosuppressive agents
(6) Unstable angina (onset or worsening within the past 3 weeks) or history of myocardial infarction within the past 6 months
(7) Uncontrolled diabetes mellitus or diabetes under continuous insulin therapy
(8) Positive for HIV antibody (testing is not mandatory)
(9) Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest CT

Target sample size

120

Name of lead principal investigator

1st name	Yukinori
Middle name
Last name	Kurokawa

Organization

Graduate School of Medicine, The University of Osaka

Division name

Department of Gastroenterological Surgery

Zip code

565-0871

Address

2-2-E2, Yamadaoka, Suita-shi, Osaka

TEL

06-6879-3251

Email

ykurokawa@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name	Takuro
Middle name
Last name	Saito

Organization

Graduate School of Medicine, The University of Osaka

Division name

Department of Gastroenterological Surgery

Zip code

565-0871

Address

2-2-E2, Yamadaoka, Suita-shi, Osaka

TEL

06-6879-3251

Homepage URL

Email

tsaito@gesurg.med.osaka-u.ac.jp

Institute

The University of Osaka

Institute

Department

Personal name

Organization

Anaut Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Department of Gastroenterological Surgery, Graduate School of Medicine, The University of Osaka

Address

2-2-E2, Yamadaoka, Suita-shi, Osaka

Tel

06-6879-3251

Email

tsaito@gesurg.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院（大阪府）、金沢大学附属病院（石川県）、京都大学医学部附属病院（京都府）、がん研有明病院（東京都）、藤田医科大学病院（愛知県）

Date of disclosure of the study information

2025

Year

11

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

11

Month

18

Day

Date of IRB

Anticipated trial start date

2025

Year

11

Month

26

Day

Last follow-up date

2028

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

11

Month

18

Day

Last modified on

2025

Year

11

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068386