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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000027759 |
Receipt No. | R000031793 |
Scientific Title | Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2018/02/24 |
Basic information | ||
Public title | Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. | |
Acronym | Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. | |
Scientific Title | Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. | |
Scientific Title:Acronym | Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. | |
Region |
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Condition | |||||
Condition | Lymphedema and lymphatic disease | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Using indocyanine green lymphography to investigate the pathology and the effectiveness of surgical remedies in lymphedema patients by analyzing pre-, intra-, and post-operative lymphatic assessments, comparing pre and postoperative changes, and assessing the associated clinical symptoms. Moreover, we focus on the patency rate of lymphatic venous anastomosis. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | We analyze the assesment pre-operation and every 6 month. Patient chart (name, patient ID, clinical history, pre and postoperative course, limb circumference, tissue stiffness); echogram, CT, MRI, lymphoscintigraphy, indocyanine green lymphography, and lymphoangiography obervations; blood test (complete blood count, chemistry, coagulation, blood type); histopathological analysis (collecting lymphatic vessel, adipose tissue, skin tissue, etc.); clinical photography (bilateral upper limbs for upper limb edema, bilateral lower limbs, abdominal, and inguinal area for lower limb lymphedema); health-related QOL analysis using Short Form (SF)-36 Health Survey; patient weight; general physical and image observationsMoreover, we focus on the patency rate of lymphatic venous anastomosis. |
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 |
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Interventions/Control_1 | Indocyanine green (ICG) lymphography and ultrasound for the patency rate of Lymphatic venous anastomosis(LVA) | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | All Subjects included in this study are lymphedema and lymphatic disease patients undergoing surgical treatment at our department who have been fully informed of all clinical tests, questionnaires, surgical treatments, and the purpose and analysis of this study and have all consented in writing. No age restriction and exclusion criteria were set. | |||
Key exclusion criteria | none | |||
Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saiseikai Kawaguchi General Hospital | ||||||
Division name | Lymphatic and Reconstructive Surgery | ||||||
Zip code | |||||||
Address | 5-11-5, Nishikawaguchi, Kawaguchi-shi, Saitama, Japan | ||||||
TEL | 0482531551 | ||||||
mihara-m@saiseikai.gr.jp |
Public contact | |||||||
Name of contact person |
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Organization | Saiseikai Kawaguchi General Hospital | ||||||
Division name | Financial and legal department | ||||||
Zip code | |||||||
Address | 5-11-5, Nishikawaguchi, Kawaguchi-shi, Saitama, Japan | ||||||
TEL | 0482531551 | ||||||
Homepage URL | |||||||
zaimuhoumu@saiseikai.gr.jp |
Sponsor | |
Institute | Saiseikai Kawaguchi General Hospital |
Institute | |
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Funding Source | |
Organization | none |
Organization | |
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Category of Funding Organization | Self funding |
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Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | No longer recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031793 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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