Lymph Node Disease Clinical Trial
Official title:
Performing a Lymphatic-venous Anastomosis at Time of Nodal Dissection in Patients Requiring Complete Axillary or Groin Dissection for the Prevention of Lymphedema
Verified date | April 2021 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Lymphedema is the build-up of lymph fluid in the body's tissue causing chronic, debilitating swelling. This commonly occurs as a result of a disruption of the lymphatic system during lymph node dissection surgeries. In melanoma patients, the incidence of lymphedema ranges from 5-10% in the arms following an axillary dissection, and 28-40% in the legs following groin dissection. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an innovative microsurgical technique where blocked lymphatic vessels are drained into the blood circulation by surgically creating a shunt between a lymphatic channel and a blood vessel called a lymphatic-venous bypass. Recently, LYMPHA has been shown to prevent lymphedema when performed at the time of nodal dissection. We propose a prospective pilot study evaluating the practice of the LYMPHA technique for the primary prevention lymphedema at The Ottawa Hospital. The novel use of the LYMPHA technique holds the potential to prevent lymphedema rather than to attempt to treat it once it has already progressed and as a result will not only improve the quality of life of the cancer patients, but also decrease health care costs associated with treating lymphedema.
Status | Terminated |
Enrollment | 8 |
Est. completion date | June 3, 2020 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed primary melanoma, soft tissue sarcoma, squamous cell carcinoma or merkel cell carcinoma of the trunk or chest. - Node-positive cancer requiring an axillary or groin lymphadenectomy Exclusion Criteria: - Patients receiving a sentinel lymph node biopsy alone - Patients with a cancer on the upper or lower extremities are excluded (i.e. arms or legs). - Patients with established preoperative lymphedema - Patients with post-thrombotic syndrome, peripheral vascular disease - Pregnant patients |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Boccardo F, Casabona F, De Cian F, Friedman D, Murelli F, Puglisi M, Campisi CC, Molinari L, Spinaci S, Dessalvi S, Campisi C. Lymphatic microsurgical preventing healing approach (LYMPHA) for primary surgical prevention of breast cancer-related lymphedema: over 4 years follow-up. Microsurgery. 2014 Sep;34(6):421-4. doi: 10.1002/micr.22254. Epub 2014 Mar 26. Erratum in: Microsurgery. 2015 Jan;35(1):83. DeCian, Franco [corrected to De Cian, Franco]. — View Citation
Boccardo F, Valenzano M, Costantini S, Casabona F, Morotti M, Sala P, De Cian F, Molinari L, Spinaci S, Dessalvi S, Campisi CC, Villa G, Campisi C. LYMPHA Technique to Prevent Secondary Lower Limb Lymphedema. Ann Surg Oncol. 2016 Oct;23(11):3558-3563. doi: 10.1245/s10434-016-5282-4. Epub 2016 May 24. — View Citation
Boccardo FM, Casabona F, Friedman D, Puglisi M, De Cian F, Ansaldi F, Campisi C. Surgical prevention of arm lymphedema after breast cancer treatment. Ann Surg Oncol. 2011 Sep;18(9):2500-5. doi: 10.1245/s10434-011-1624-4. Epub 2011 Mar 3. — View Citation
Brorson H, Höijer P. Standardised measurements used to order compression garments can be used to calculate arm volumes to evaluate lymphoedema treatment. J Plast Surg Hand Surg. 2012 Dec;46(6):410-5. doi: 10.3109/2000656X.2012.714785. — View Citation
Feldman S, Bansil H, Ascherman J, Grant R, Borden B, Henderson P, Ojo A, Taback B, Chen M, Ananthakrishnan P, Vaz A, Balci F, Divgi CR, Leung D, Rohde C. Single Institution Experience with Lymphatic Microsurgical Preventive Healing Approach (LYMPHA) for the Primary Prevention of Lymphedema. Ann Surg Oncol. 2015 Oct;22(10):3296-301. doi: 10.1245/s10434-015-4721-y. Epub 2015 Jul 23. — View Citation
Gomberawalla A, Feldman S. LYMPHA: New Innovation, Not Old Practice. J Clin Oncol. 2016 Sep 1;34(25):3108-9. doi: 10.1200/JCO.2016.67.8987. Epub 2016 Jun 13. — View Citation
Mehrara BJ, Zampell JC, Suami H, Chang DW. Surgical management of lymphedema: past, present, and future. Lymphat Res Biol. 2011;9(3):159-67. doi: 10.1089/lrb.2011.0011. Review. — View Citation
Morotti M, Menada MV, Boccardo F, Ferrero S, Casabona F, Villa G, Campisi C, Papadia A. Lymphedema microsurgical preventive healing approach for primary prevention of lower limb lymphedema after inguinofemoral lymphadenectomy for vulvar cancer. Int J Gynecol Cancer. 2013 May;23(4):769-74. doi: 10.1097/IGC.0b013e318287a8e8. — View Citation
Starritt EC, Joseph D, McKinnon JG, Lo SK, de Wilt JH, Thompson JF. Lymphedema after complete axillary node dissection for melanoma: assessment using a new, objective definition. Ann Surg. 2004 Nov;240(5):866-74. — View Citation
Torrisi JS, Joseph WJ, Ghanta S, Cuzzone DA, Albano NJ, Savetsky IL, Gardenier JC, Skoracki R, Chang D, Mehrara BJ. Lymphaticovenous bypass decreases pathologic skin changes in upper extremity breast cancer-related lymphedema. Lymphat Res Biol. 2015 Mar;13(1):46-53. doi: 10.1089/lrb.2014.0022. Epub 2014 Dec 18. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in limb volume between surgery-affected and surgery-unaffected limb at baseline, 3, 6, 9, 12 and 24 months | At each follow-up visit, patients will have a physical examination and their circumferential limb measurements will be taken with measuring tape at three specific intervals up the limb. For example, patients undergoing an axillary dissection will have the circumference of their wrist taken, and then again 4 cm proximal to the wrist, then 8 cm proximal to the wrist, and so forth. The method will be used for the legs but starting at the ankle. Volume will be calculated indirectly, using Dr. Brorson's truncated cone method. | every 3 months up to a year, again at year 2 | |
Secondary | Limb-lymphedema-specific Quality of life assessment at baseline, 3, 6, 9, 12 and 24 months through the LYMQOL questionnaire | Patients will fill out a limb lymphedema-specific quality of life questionnaire (LYMQOL). This includes the LYMQOL-arm or the LYMQOL-leg. | every 3 months up to a year, again at year 2 |
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