UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042199 |
|---|---|
| Receipt number | R000046751 |
| Scientific Title | Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2025/04/26 23:31:39 |
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Basic information
Public title
Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Acronym
Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Scientific Title
Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Scientific Title:Acronym
Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Region
| Japan |
Condition
Condition
Patients with esophageal cancer who assigned to curative surgical treatment
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effect of lymphatic flow identification using indocyanine-green fluorescence imaging(IGFI) on predicting of the extent of lymph node metastasis in esophageal cancer patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, positive likelihood ratio, negative likelihood ratio, and their confidence interval when ICG staining is used as an index evaluation and Metastasis is used as a reference standard for all dissected lymph node stations.
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
| Medicine |
Interventions/Control_1
We perform endoscopic submucosal injection of ICG around the primary lesion using a four-quadrant injection pattern with a 23-gauge endoscopic injection sclerotherapy needle.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Esophageal cancer patients who assigned to curative surgical resection
1) 20yrs and older
2) PS(ECOG Performance status) 0 or 1
3) favorable major organ function
Key exclusion criteria
1) past history of ICG or Iodine hypersensitivity
2) pregnant patient
3) breast feeding patient
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Yagi |
Organization
Tokyo University Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
yagik-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Shiomi |
Organization
Tokyo University Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
sshiomi-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo University Hospital, Department of Gastrointestinal Surgery
Institute
Department
Personal name
Funding Source
Organization
Tokyo University Hospital
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
Research Ethics Office, Graduate School of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2020 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00464-023-10368-4
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00464-023-10368-4
Number of participants that the trial has enrolled
54
Results
The sensitivity of lymph nodes that showed fluorescence to predict metastatic lymph nodes was 50% (95% CI 41-59%). Having received preoperative chemotherapy was an independent risk factor for having metastatic lymph nodes with a false-negative diagnosis (odds ratio 4.82; 95% CI 1.28-18.19). The sensitivity of our technique for predicting metastatic lymph node involvement in patients who did not receive preoperative chemotherapy was 79% (63-90%).
Results date posted
| 2025 | Year | 04 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were as follows: (1) patients with cT1-4aN0-3M0-1 esophageal or esophagogastric junction cancer; (2) patients with good primary organ function and no requirement for any surgical intervention; and (3) patients who provided written consent after sufficient explanation for participation in this study. The exclusion criteria were as follows: (1) patients with a history of hypersensitivity to iodine-containing drugs; (2) patients diagnosed preoperatively with multiple primary cancers; (3) patients with concurrent head and neck cancer, gastric cancer, or lung cancer, or who had a history of these cancers within the past 5 years; and (4) patients with stenosis due to a tumor or other causes that prevented the injection of ICG on the distal side of the tumor.
Participant flow
62 patients agreed to participate in the study and underwent preoperative injection of ICG solution; no adverse events related to the injections were observed. Among the 62 patients, ICG injection could not be completed in one patient due to tumor-derived stenosis, the esophagectomy was interrupted in one patient due to massive tumor invasion, ex vivo imaging data were missing for one patient due to difficulties experienced with the endoscopic fluorescence imaging system, and five patients were diagnosed with multiple esophageal cancers in the final histological examinations; therefore, these patients were excluded from the population for analyses. Thus, data for 54 patients were analyzed in this study.
Adverse events
None.
Outcome measures
The sensitivity, specificity, positive likelihood ratio (PLR), and negative likelihood ratio (NLR) of the intraoperative near-infrared fluorescence status to detect meta-positive lymph nodes
The characteristics of patients with lymph nodes associated with high false-negative rates
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046751
