Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.

Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. - Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025891

Enrollment

Registered

2017-02-01

Start date

2017-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema and lymphatic disease

Interventions

Indocyanine green (ICG) lymphography and Lymphatic venous anastomosis(LVA)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Saitamaken Saiseikai Kawaguchi General Hospital Patients who received lymphatic surgery / reconstructive surgery 2) Patients diagnosed with secondary lower extremity lymphoedema by lymphoscintigraphy 3) Patients judged to have the ability to answer interrogation 4) Patients who obtained document consent by the patients themselves freely with sufficient understanding after receiving sufficient explanation for participation in this study. 5) In cases where the patient is a minor, 4) In addition to the patient caregiver sufficient understanding, document consent is obtained.

Exclusion criteria

Exclusion criteria: Exclusion criteria Patients who conflict with the following criteria shall not be included in this study. 1) Patients with postoperative observation period of less than 6 months 2) Patients with complication of edema due to heart failure / renal failure etc. 3) Cases judged inappropriate by test doctor

Design outcomes

Primary

Measure	Time frame
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 observations.	—

Measure

Time frame

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 observations.

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Countries

Japan

Contacts

Public ContactYoshinori Shimizu

Saiseikai Kawaguchi General Hospital Financial and legal department

zaimuhoumu@saiseikai.gr.jp048-253-1551

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026