Microvascular Breast Reconstruction With Lymph Node Transfer

NCT04246034 | Withdrawn

• 1 other identifier: VLNT for lymphedema
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

this study aims to evaluate the outcomes of simultaneous free abdominal flap \& vascularized lymph node transfer for both breast reconstruction and postmastectomy lymphedema

Conditions

Lymphedema; Lymphedema of Upper Arm; Mastectomy; Lymphedema

Keywords

VLNT; breast reconstruction; postmastectomy lymphedema; vascularized lymph node transfer; lymphedema surgery; microsurgery

Outcome Measures

Primary Outcomes (2)

• Change in upper limb volume

  Assessment of volume reduction by measuring limb circumference of affected and non affected upper limbs at fixed points from shoulder, elbow \& wrist joints

  6-12 months

• Change in lymphatic flow

  lymphoscintigraphy will be used to trace radiological signs of Lymphatic flow improvement such as reduced dermal backflow, appearance of new lymph drainage channels, reduced stasis and increased rate of radiolabeled tracer clearance

  6-12 months

Secondary Outcomes (2)

• Quality of life measure for limb lymphedema (LYMQOL)

  6-12 months

• Quality of life measure for breast

  6-12 months

Study Arms (1)

Cases

EXPERIMENTAL

As described by Saaristo et al. in 2012, the surgical technique starts with wide axillary scar removal, followed by elevation of contralateral dual flap which includes DIEP/MS-TRAM with attached groin lymph nodes and fat, then the anastomosis is preferably done to internal mammary vessels.

Procedure: Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer

Interventions

Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer PROCEDURE

simultaneous free abdominal flaps with VLNT from groin are transferred on a single pedicle for breast reconstruction and postmastectomy lymphedema

Cases

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: as the scope of study is breast cancer, participant should be of female gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients of 20-65 years old
• Patients seeking autologous breast reconstruction and complain of clinically diagnosed arm lymphedema
• Deficient lymphatic drainage on lymphoscintigraphy
• Stage II and III Lymphedema
• no active cellulitis
• more than 12 months of follow-up

You may not qualify if:

• Females \< 20 or \>65 years old
• distant metastasis
• brachial plexus neuritis.
• Patients with unhealthy and obstructed recipient veins or congestive heart disease with limited venous return may not be a suitable candidate for the procedure.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Saaristo AM, Niemi TS, Viitanen TP, Tervala TV, Hartiala P, Suominen EA. Microvascular breast reconstruction and lymph node transfer for postmastectomy lymphedema patients. Ann Surg. 2012 Mar;255(3):468-73. doi: 10.1097/SLA.0b013e3182426757.

  PMID: 22233832 BACKGROUND

• DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.

  PMID: 23540561 BACKGROUND

• Smile TD, Tendulkar R, Schwarz G, Arthur D, Grobmyer S, Valente S, Vicini F, Shah C. A Review of Treatment for Breast Cancer-Related Lymphedema: Paradigms for Clinical Practice. Am J Clin Oncol. 2018 Feb;41(2):178-190. doi: 10.1097/COC.0000000000000355.

  PMID: 28009597 BACKGROUND

• Executive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2016 Consensus Document of the International Society of Lymphology. Lymphology. 2016 Dec;49(4):170-84.

  PMID: 29908550 BACKGROUND

• Pappalardo M, Patel K, Cheng MH. Vascularized lymph node transfer for treatment of extremity lymphedema: An overview of current controversies regarding donor sites, recipient sites and outcomes. J Surg Oncol. 2018 Jun;117(7):1420-1431. doi: 10.1002/jso.25034. Epub 2018 Mar 24.

  PMID: 29572824 BACKGROUND

• Engel H, Lin CY, Huang JJ, Cheng MH. Outcomes of Lymphedema Microsurgery for Breast Cancer-related Lymphedema With or Without Microvascular Breast Reconstruction. Ann Surg. 2018 Dec;268(6):1076-1083. doi: 10.1097/SLA.0000000000002322.

  PMID: 28594742 BACKGROUND

• Chang EI, Masia J, Smith ML. Combining Autologous Breast Reconstruction and Vascularized Lymph Node Transfer. Semin Plast Surg. 2018 Feb;32(1):36-41. doi: 10.1055/s-0038-1632402. Epub 2018 Apr 9.

  PMID: 29636652 BACKGROUND

• Nguyen AT, Chang EI, Suami H, Chang DW. An algorithmic approach to simultaneous vascularized lymph node transfer with microvascular breast reconstruction. Ann Surg Oncol. 2015 Sep;22(9):2919-24. doi: 10.1245/s10434-015-4408-4. Epub 2015 Jan 27.

  PMID: 25623599 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Youssef S Hassan, MD

  Assiut University Hospitals - Plastic Surgery Dept.

  STUDY CHAIR

• Haitham Khalil, MD, FRCS

  Divison of Plastic and Reconstructive Surgery (University Hospitals Birmingham)

  STUDY DIRECTOR

• Awny M Asklany, MD

  Assiut University Hospitals - Plastic Surgery Dept.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 29, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share