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Trial Title:
The Effectiveness of Lymphatic Bypass Supermicrosurgery
NCT ID:
NCT05682885
Condition:
Breast Cancer Related Lymphedema
Lymphedema Arm
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Conditions: Keywords:
Lymphatic Bypass Supermicrosurgery
Primary Lymphedema Prevention
Axillary Lymph Node Dissection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study is a single-blind pragmatic parallel arm randomized clinical trial to analyze
the effectiveness of lymphatic bypass supermicrosurgery (LBS).
Primary purpose:
Prevention
Masking:
Single (Participant)
Masking description:
Blinding is implemented in two conditions: the main researcher (Bayu Brahma) will not
know the identity and medical history of the patient when assessing the indocyanine green
(ICG) lymphography results and the patients will not know the received type of surgical
procedure.
Intervention:
Intervention type:
Procedure
Intervention name:
Lymphatic Bypass Supermicrosurgery
Description:
Axillary Lymph Node Dissection with Lymphatic Bypass Supermicrosurgery
Arm group label:
Axillary lymph node dissection with LBS
Summary:
This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and
axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer
treatment-related lymphedema (BCRL).
Detailed description:
In the intervention group, LBS was performed after ALND with the intima-to-intima
coaptation using the supermicrosurgery technique. The anastomosis is done between the
afferent lymphatic vessel to the recipient's vein, or if possible, from the afferent to
the efferent lymphatic vessel. The upper extremity lymphedema (UEL) index and indocyanine
green (ICG) lymphography are utilized to evaluate the development of lymphedema.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Breast cancer patient aged >18 years old
- Breast cancer patient with clinically ALNs metastases (cN1 or cN2).
- Breast cancer patient with no clinical metastasis and tumor size ≥5cm or no sentinel
lymph node biopsy facility in the hospital.
- Any breast cancer patients that receive neoadjuvant systemic therapy.
Exclusion Criteria:
- Stage IV breast cancer patients who do not show clinical and radiological
improvement after primary systemic therapy.
- Breast cancer patients with previous surgeries such as mastectomy, axillary lymph
node biopsy, sentinel lymph node biopsy (SLNB), and ALND.
- Breast cancer patients with prior breast, chest wall, axillary, or neck
radiotherapy.
- Breast cancer patients with preoperative lymphatic system abnormality detected by
ICG lymphography.
- Breast cancer patients with iodine allergy, asthma, decreased kidney function,
pregnancy, and lactation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dharmais National Cancer Center Hospital
Address:
City:
Jakarta
Zip:
11420
Country:
Indonesia
Status:
Recruiting
Contact:
Last name:
Ramadhan Karsono, PhD
Phone:
+62-812-1045-970
Email:
ramadhan@dharmais-surgonc.com
Investigator:
Last name:
Bayu Brahma, MD
Email:
Principal Investigator
Start date:
October 6, 2022
Completion date:
July 2024
Lead sponsor:
Agency:
Dharmais National Cancer Center Hospital
Agency class:
Other
Source:
Dharmais National Cancer Center Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05682885
