UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057825 |
|---|---|
| Receipt number | R000066100 |
| Scientific Title | Prospective, single-arm, study on the usefulness of blood flow evaluation of gastric tube and remnant esophagus using the SPY-QP software system in minimally invasive esophagectomy for esophageal cancer |
| Date of disclosure of the study information | 2025/05/12 |
| Last modified on | 2025/05/10 10:50:28 |
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Basic information
Public title
Prospective, single-arm, study on the usefulness of blood flow evaluation of gastric tube and remnant esophagus using the SPY-QP software system in minimally invasive esophagectomy for esophageal cancer
Acronym
Prospective, single-arm, study on the usefulness of blood flow evaluation of gastric tube and remnant esophagus using the SPY-QP software system in minimally invasive esophagectomy for esophageal cancer
Scientific Title
Prospective, single-arm, study on the usefulness of blood flow evaluation of gastric tube and remnant esophagus using the SPY-QP software system in minimally invasive esophagectomy for esophageal cancer
Scientific Title:Acronym
Prospective, single-arm, study on the usefulness of blood flow evaluation of gastric tube and remnant esophagus using the SPY-QP software system in minimally invasive esophagectomy for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the incidence of anastomotic leakagei in patients with blood flow assessment using the SPY-QP fluorescence assessment software system during esophagectomy with gastric tube reconstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of anastomotic leakage
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Visualisation of the fluorescence excited by indocyanine green in the gastric tube and remnant esophageal wall using a Stryker video processor with integrated light source and SPY PHI, and quantitative blood flow assessment using the SPY-QP fluorescence evaluation software system.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patient has a histological diagnosis of esophageal squamous cell carcinoma.
2) The planned operative procedure is a right thoracic approach subtotal esophagectomy and gastric tube reconstruction.
3) The patient is at least 18 years of age on the date of registration.
4) Gender is not relevant.
5) PS is 0 or 1 according to ECOG criteria.
6) Latest laboratory values within 28 days prior to enrolment are all below.
Neutrophil count > 1,500/mm3
Platelet count > 7.5 x 104 /mm3
Hemoglobin > 9.0 g/dL
Creatinine: < 1.5 times upper limit of normal
AST/ALT: < 3 times upper limit of normal
Total bilirubin: normal Less than 1.5 times the upper limit (for Gilbert's syndrome:
Less than 3.0 mg/dL)
7)The patient's free written consent to participate in this clinical study has been obtained.
Key exclusion criteria
1) Has an allergy to iodine or indocyanine green.
2) Have active systemic infections.
3) Requires treatment with systemic corticosteroids (prednisone equivalent >10 mg/day: inhaled and topical steroids and hormone replacement therapy are acceptable) or other immunosuppressive agents.
4) Planned two-stage surgery.
5) The patient is unwilling to use contraception and is pregnant or lactating.
6) Patients with dementia or psychiatric disorders requiring treatment that make it difficult to obtain their consent.
7) Other patients who are deemed inappropriate by the person in charge of this clinical research.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Goto |
Organization
Kobe University Hospital
Division name
Division of Gastrointestinal Surgery
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783825925
hirogoto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Goto |
Organization
Kobe University Hospital
Division name
Division of Gastrointestinal Surgery
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783825925
Homepage URL
ichige@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
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
Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
0783826669
chiken@med.kobe-u.ac.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
| 2025 | Year | 05 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 10 | Day |
Last modified on
| 2025 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066100
