LYMPHA: Eliminating the Burden of Lymphedema in Patients Requiring Nodal Dissection

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03073096
• Other study ID #: 20170146 form 6131
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 3, 2020

Study information

• Verified date: April 2021
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Consenting patients will have the LYMPHA procedure at the time of planned axillary or groin dissection surgery for the prevention of upper and lower extremity lymphedema, respectively. The node dissection will be performed by Dr. Nessim, while the LYMPHA technique will be performed by the plastic surgeon, Dr. Momtazi, trained in microsurgical technique. The LYMPHA procedure consists of performing lymphatic-venous anastomoses (LVA) at the time of the node dissection. Patent blue dye will be injected into the patient approximately 10 minutes before skin incision. This will allow mapping of the lymphatic channels for identification for bypass. The node dissection will then be performed with preservation of the saphenous vein in the leg and the anterior branch of the axillary vein in the axilla. Afferent lymphatic vessels will be sutured into the saphenous vein or a branch of the axillary vein distal to a competent valve, respectively. The total duration of the surgery is approximately 3 hours. The LYMPHA technique accounts for an additional 30 minutes to the standard 2-2.5 hours allocated to the node dissection. Pre-surgery, patients will have baseline limb circumference measurements of both the surgery-affected and unaffected limbs (arms or legs). Patients will be followed up clinically at every 3 months up to a year, and then again at the end of the second year (at the 24 month-mark only). 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 (13). Patients will also fill out a limb lymphedema-specific quality of life questionnaire (LYMQOL) administered by the Clinical Research Coordinator pre- and post-surgery. Each patient will have a total of 2 years of participation time. Pre-surgery, patients will have baseline limb circumference measurements of both the surgery-affected and unaffected limbs (arms or legs). Patients will be followed up clinically at every 3 months up to a year, and then again at the second year. 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. Patients will also fill out a limb lymphedema-specific quality of life questionnaire (LYMQOL) administered pre- and post-surgery. 1. Primary Objective: To evaluate the success rate of performing the LYMPHA procedure. Success is defined as a completed LYMPHA procedure i.e. successful LVA. 2. Secondary Objective: To evaluate the feasibility of follow-up assessments i. establish the ability to obtain pre- and post- limb measurements ii. obtain limb-specific quality of life information iii. design a protocol for a randomized controlled trial comparing lymphedema rates in patients receiving a lymphadenectomy + lymphatic-venous bypass versus lymphadenectomy alone.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lymph Node Disease
• Lymphedema

Intervention

Procedure:
• LVA at time of nodal dissection
Patients will receive a lymphatic-venous anastomosis at time of their required nodal dissection

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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

van Akkooi AC, Bouwhuis MG, van Geel AN, Hoedemaker R, Verhoef C, Grunhagen DJ, Schmitz PI, Eggermont AM, de Wilt JH. Morbidity and prognosis after therapeutic lymph node dissections for malignant melanoma. Eur J Surg Oncol. 2007 Feb;33(1):102-8. Epub 2006 Dec 11. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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