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Application of Dual Tracing with Indocyanine Green and Methylene Blue in Laparoscopic Pelvic Lymph Node Dissection for Acral Malignant Melanoma

Application of Dual Tracing with Indocyanine Green and Methylene Blue in Laparoscopic Pelvic Lymph Node Dissection for Acral Malignant Melanoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127597
Enrollment
Unknown
Registered
2026-07-02
Start date
2026-07-02
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

acral malignant melanoma

Interventions

Dual-tracing group / experimental group:Laparoscopic pelvic lymph node dissection assisted by dual tracing with indocyanine green and methylene blue.

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed acral malignant melanoma; 2. No relevant treatment received before surgery; 3. Clinical evidence of lymph node metastasis, meeting the guideline indications for pelvic lymph node dissection; 4. No surgical contraindications, normal heart and lung function, physically able to tolerate combined surgery; 5. Obtained informed consent from the patient;

Exclusion criteria

Exclusion criteria: 1.Malignant melanoma of the skin arising from sites other than acral areas. 2.Patients who have received preoperative chemotherapy or radiotherapy, or who are admitted for reoperation due to recurrence. 3.Pregnant or lactating women, or patients with severe mental illness. 4.History of previous pelvic surgery. 5.History of other malignancies within the past five years. 6.History of unstable angina, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past six months. 7.History of continuous systemic corticosteroid therapy within the past one month. 8.Requirement for concurrent surgical treatment for other diseases. 9.History of iodine allergy, renal insufficiency, or glucose-6-phosphate dehydrogenase deficiency. 10.Patients who refuse laparoscopic surgery or do not undergo surgical treatment for other reasons.

Design outcomes

Primary

MeasureTime frame
Pathology: Total number of lymph nodes, number of visualized lymph nodes, number of non-visualized lymph nodes, number of metastases in visualized/non-visualized lymph nodes, and total number of metastases;Postoperative Recovery Indicators;Fluorescence Intensity and Imaging Performance;Recurrence, Metastasis, and Survival-related Outcomes;

Secondary

MeasureTime frame
Postoperative Complications;Estimated Blood Loss;ntraoperative Complications;Conversion to Open Surgery and Reason for Conversion;Operative Time;Blood Transfusion Volume;

Countries

China

Contacts

Public ContactYao Liang

Sun Yat-sen University Cancer Center

liangyao@sysucc.org.cn+86 20 8734 3910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026