A Japanese phase III multicenter, single-arm, open-label clinical trial to assess the efficacy and safety of the diagnosis/treatment of lymphedema by ICG fluorescent lymphangiography in patients with secondary lymphedema

JRCT ID: jRCT2031190064

Registered date:30/07/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: lymphedema
• Date of first enrollment: 24/06/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Appropriately select patients for lympho-venous anastomosis for patients with lymphedema, and identify lymphatic vessels before and during surgery and confirm the presence or absence of anastomosis.

Outcome(s)

• Primary Outcome: The primary endpoint of this study is to know the identification rate of the lymphatic vessels at the incision site based on preoperative fluorescent lymphangiography.

Secondary Outcome

(1) Sensitivity and specificity of lymphedema diagnosis by ICG fluorescent lymphangiography when using 99mTc lymphoscintigraphy as the standard test
(2) The outer diameter of the identified lymphatic vessels (the number of the overlapped lymphatic vessels and the outer diameter of the respective vessels), as well as the distance from the skin surface to the lymphatic vessels (during surgery)
(3) Usefulness of ICG fluorescent lymphangiography when examining the presence or absence of the patency of the anastomosis site during LVA (during surgery)

Safety secondary endpoints

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inclusion criteria (1)
A patient who meets all of the following conditions should be subject to the primary registration: A patient who meets all of the following conditions should be subject to the primary registration
1)Who was diagnosed with secondary lymphedema of the extremities
2)Who was diagnosed with lymphedema of stage I to II lymphedema as defined by the
International Society of Lymphology;
3)Who was 20 years or older in age at the time of giving consent; and
4)Who gave his/her free will-based written informed consent after receiving a sufficient explanation prior to enrollment in the present clinical trial and based on a sufficient understating

Inclusion criteria (2)
A patient, who meets all of the following conditions, should be subject to the secondary registration:
1)In whom the site of linear pattern was confirmed by ICG fluorescent lymphangiography after the primary registration; and
2)Who was diagnosed with lymphedema by 99mTc lymphoscintigraphy after the primary registration

Exclude criteria

Exclusion criteria (1)
A patient who falls under any of the following conditions should not be subject to the primary registration
1)Who has primary lymphedema
2)Who has allergy against iodine
3)Who has shown shock caused by ICG administration in the past
4)Who has shown symptoms of allergy caused by 99mTc administration in the past
5) Who has a history of hypersensitivity to xylocaine component or amide type local anesthetic.
6)Who is lean (BMI 18 kg/m2) or obese (BMI 30 kg/m2)
7)Who is a woman being pregnant, being breast-feeding, or willing to become pregnant during the trial period
8)Who was otherwise considered inappropriate for enrollment in the clinical trial by the investigator (subinvestigator) , or
9)Who has lymphedema in both the upper and lower extremities, thus not allowing limitation to either the upper or lower extremities

Exclusion criteria (2)
1)A patient, whose ICG fluorescent lymphangiogram falls under any of the following conditions, should not be subject to the secondary registration:
(1)In whom the linear pattern cannot be confirmed because of presenting only the area of dermal back flow pattern that is indicative of the reversed current of the collecting lymphatic vessels into the skin and the area where a fluorescent lymphangiogram is not found at all, which led to the judgment that the lymphatic vesels are difficult to identify.
(2)Who was otherwise judged to be inappropriate as a subject to the present trial;
2)Who has had symptoms of allergy caused by the subcutaneous injection of ICG; or
3)Who was diagnosed to have edema due to causes other than lymphedema because of presenting normal lymphoscintigraphic findings.

Related Information

• Primary Sponsor: Akita Shinsuke