A Prospective Study on the Treatment of cLM Based on ICG Imaging

NCT ID: NCT06275022

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-06-30

Brief Summary

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The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. To clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (cLM) in children, is helpful for exploring pathogenesis of cLM, and providing a clearer scientific basis for subsequent surgical intervention. It also provides alternative for the future diagnosis and treatment of cLM.

Participants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation.

Researchers will compare difference in curative effect between two groups.

Detailed Description

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Conditions

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Lymphatic Malformation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Macro/mixed cystic lymphatic A

Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy

Group Type EXPERIMENTAL

Inflow occlusion with perforation of septation and sclerotherapy

Intervention Type PROCEDURE

Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy

Macro/mixed cystic lymphatic B

Perforation of septation and sclerotherapy

Group Type ACTIVE_COMPARATOR

Perforation of septation and sclerotherapy

Intervention Type PROCEDURE

Perforation of septation and sclerotherapy

Microcystic lymphatic A

Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Group Type EXPERIMENTAL

Indocyanine green-guided partial resection and sclerotherapy

Intervention Type PROCEDURE

Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Microcystic lymphatic B

Partial resection and sclerotherapy

Group Type ACTIVE_COMPARATOR

Partial resection and sclerotherapy

Intervention Type PROCEDURE

Partial resection and sclerotherapy

Interventions

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Inflow occlusion with perforation of septation and sclerotherapy

Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy

Intervention Type PROCEDURE

Perforation of septation and sclerotherapy

Perforation of septation and sclerotherapy

Intervention Type PROCEDURE

Indocyanine green-guided partial resection and sclerotherapy

Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Intervention Type PROCEDURE

Partial resection and sclerotherapy

Partial resection and sclerotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

(1) no previous intervention; (2) cLM diagnosed by pretreatment magnetic resonance imaging (MRI); (3)3 to 6 months post-treatment follow-up; (4) Superfacial cLM

Exclusion Criteria

(1) history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection
Minimum Eligible Age

30 Days

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tao Han

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weimin Shen, Dr.

Role: STUDY_DIRECTOR

Children's Hospital of Nanjing Medical University

Locations

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Children's hospital of Nanjing medical university

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tao Han, Dr.

Role: CONTACT

+86 186 5190 3495

Facility Contacts

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Tao Han, Dr.

Role: primary

+86 186 5190 3495

Other Identifiers

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NanjingCH011665

Identifier Type: -

Identifier Source: org_study_id

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