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Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis

18 Years
Open (Enrolling)
Breast Cancer, Genitourinary Cancer, Malignant Female Reproductive System Neoplasm, Melanoma, Sarcoma

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Trial Information

Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis

If you choose to take part in this study, you will have 1 small piece of tissue (about the
size of a pencil eraser) collected from the arm with the lymphedema and another small piece
of tissue will be collected from the unaffected arm. A total of 4 samples will be collected
by excisional biopsy (2 samples before the surgery and 2 more samples again 6 months after
the surgery). To collect an excisional biopsy, the area of skin is numbed with anesthetic
and a small cut is made to remove all or part of the affected tissue.

Blood (about 5 teaspoons each time) will also be drawn before the surgery and 1 more blood
sample again 6 months after the surgery. If possible, the blood samples will be collected
during already scheduled blood draws to avoid additional needle sticks.

The tissue and blood samples will be used for testing to evaluate the level of the tissue
inflammation and to check for any build-up of excess tissue.

Length of Study:

After both tissue and blood samples have been collected, your participation in this study
will be over.

This is an investigational study.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients undergoing lymphatico-venular bypass for lymphedema.

2. History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.

3. A minimum of three (3) months post-op from any surgical interventions.

4. A minimum of six (6) months from the last dose of chemotherapy.

5. Patients with unilateral lymphedema.

Exclusion Criteria:

1. Active systemic infection or allergic reaction.

2. Active parasitic infection.

3. History of primary (congenital) lymphedema.

4. Metastatic cancer.

5. History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis,
systemic sclerosis.

6. History of other fibroproliferative disorders including cirrhosis, pulmonary
fibrosis, kidney fibrosis, systemic sclerosis, scleroderma.

7. Current treatment with steroids.

8. Concurrent secondary systemic cancer exclusive of cutaneous malignancies.

9. Treatment with myelosuppressive or stimulatory drugs within six (6) months of

10. History of bone marrow transplantation.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Th2 Cytokine Levels

Outcome Description:

5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

David W. Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Genitourinary Cancer
  • Malignant Female Reproductive System Neoplasm
  • Melanoma
  • Sarcoma
  • Breast cancer
  • Genitourinary cancer
  • Gynecological cancer
  • Malignant Female Reproductive System Neoplasm
  • Melanoma
  • Sarcoma
  • Inflammatory Response
  • Inflammatory proteins
  • Tissue Fibrosis
  • Lymphatico-venous Bypass Surgery
  • Punch biopsy
  • Lab collections
  • Th2 immune phenotype
  • Lymphedema
  • Breast Neoplasms
  • Neoplasms
  • Fibrosis
  • Genital Neoplasms, Female
  • Melanoma
  • Urogenital Neoplasms
  • Sarcoma



UT MD Anderson Cancer Center Houston, Texas  77030