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Chapter 12
Clinical Staging
Sandro Michelini, Marco Cardone, Alessandro Failla, and Giovann Moneta
The problem of the staging of lymphedema is a perennial topic for discussion at
consensus meetings within national and international congresses. First of all, for
definitions and scope of pathology to be universally accepted, the requirements of
simplicity, recognizability, and worldwide utilization must be met.
Four proposals based on different clinical and instrumental aspects of pathology
have been presented at the international level, yet only some of the attributes are
common to all. Through the work of a special world commission, a synthesis of the
different proposals will provide scientific communication with universally recognized and accepted parameters.
Primary and secondary lymphedemas have different clinical stages of evolution,
in part mutually reversible, that influence affected patients differently from the
physical, emotional, and psychological points of view.
Achieving common acceptance of stages of lymphedema, as in other diseases,
seems to be a problem that cannot be postponed further for reasons of “scientific
communication” and for the undoubted medicolegal and social impact. In more
advanced clinical stages, the condition takes on the characteristics of a real “social
disease,” the costs of which are generated both from medical care and from loss of
productive capacity.
The clinical staging, reported in the “consensus document” of the International
Society of Lymphology,1 currently includes four clinical stages (Table 12.1); it initially included three clinical stages (I, II, and III), but recently, motivated by our
Italian classification,
clinical” aspect of the primary and secondary types of lymphedema, potentially
progressive (e.g., mastectomy with coincident limbs), the pre-clinical stage, defined
2-5
which underscored the importance of including the “pre-
S. Michelini (*)
San Giovanni Battista Hospital, Rome, Italy
B.-B. Lee et al. (eds.), Lymphedema,
DOI 10.1007/978-0-85729-567-5_12, © Springer-Verlag London Limited 2011
89
90 S. Michelini et al.
Table 12.1 Staging according to the “consensus document” of the International Society of
Lymphology
Clinical stage Evidence
0 Subclinical with possible clinical evolution
I Edema regressing with treatments with positive pitting test
II Edema partially regressing with treatments with negative pitting test
III Elephantiasis with cutaneous complications and recurrent infections
as stage 0, was included. Stage 0 refers to a latent or sub-clinical condition, where
swelling is not evident despite impaired lymph transport. Stage I represents an early
accumulation of fluid relatively high in protein content (in contrast to “venous
edema”) that subsides with limb elevation. Pitting may occur. Stage II signifies that
limb elevation alone rarely reduces tissue swelling and that pitting is manifest. Stage
III encompasses lymphostatic elephantiasis where pitting is absent and trophic skin
changes, such as acanthosis, fat deposits, and warty overgrowths develop. The
severity of the stages is based on the volume differences: minimal (<20% increase),
moderate (20–40% increase), and severe (>40% increase). These stages only refer
to the physical condition of the extremities.
Some healthcare workers examining disability utilize the World Health
Organization’s guidelines for the International Classification of Functioning,
Disability, and Health (ICF). Quality of Life issues (social, emotional, physical
inabilities, etc.) may also be addressed by individual clinicians and can have a
favorable impact on therapy and compliance.
6
At the recent XX World Congress of the International Society of Lymphology,
held in Brazil, in a special Consensus session, a special world commission was
organized to finalize a new, official staging of the International Society.
2
In Germany, led by Prof. Ethel Foeldi, four clinical stages11 have been introduced
for the first time, adding to those reported in the actual ‘consensus document’ a stage
0, which represents all cases of sub-clinical lymphedema, but with a significant risk
of clinical progression (e.g., lymphoscintigraphy strongly predictive; Table 12.2).
Since 1994,2 five clinical stages have been recognized in Italy (Table 12.3). This
system emphasizes the importance of pre-clinical cases at risk of evolution (in stage I)
and cases of elephantiasis with major chronic inflammatory and infectious complications and risk of neoplastic tissue degeneration (stage V). Depending on the stage it is
also possible to direct the therapeutic treatment toward the corresponding preventive
options.
7
In Japan, a team led by Prof. Moriji Ohkuma, a dermatologist with heightened
sensitivity to infectious complications in cutaneous and subcutaneous tissues, proposed four-phase staging involving inspection and palpation of the affected areas
and of assessing the frequency of the infectious episodes and inflammatory complications; based upon the developmental stage, it is possible to obtain prognostic
information (Table 12.4). This is obviously a staging with a more strictly dermatological point of view; while clinical, it is conceptually valid, since it considers some
clinical and inflammatory aspects, complications that are frequently found in
patients with both primary and secondary forms of lymphedema.
8,9
12 Clinical Staging
Table 12.2 Staging according to the German Society of Lymphology (Prof. E. Foeldi)
Clinical stage Evidence
0 No edema, but evidence of a risk condition for evolution
I Edema regressing with treatments with positive pitting test
II Edema partially regressing with treatments with negative pitting test
III Elephantiasis with cutaneous complications and recurrent infections
Table 12.3 Staging according to the Italian Society of Lymph-Angiology (Michelini–Campisi)
Clinical stage Evidence
I No edema in individuals at risk (pre-clinical)
II Edema that regresses spontaneously with elevation and with night rest
III Edema that does not regress spontaneously, only with treatments and partially
IV Elephantiasis (abolition of tendon and bone projections)
V Elephantiasis complicated by cutaneous and recurrent infections and
Table 12.4 Staging according to the Japanese Society of Lymphology (Prof. M. Ohkuma)
Clinical stage Inspection Palpation
I Normal Pitting ++ Absent Temporary
II Thin skin Increase in thickness,
III Cutaneous
IV Verrucosis Pitting absent Very often Worsening
impairment of deep body structures (muscles, joints)
Acute
Dermo-epidermitis Prognosis
Absent Permanent
Present Worsening
lichenification
pitting +
Increase in thickness,
pitting −
91
The staging proposed in South America, and, in particular in Brazil by Prof.
Mauro Andrade, is of substantial interest because, in addition to taking into account
the importance of pre-clinical cases at risk of development of infectious and degenerative complications, it also analyzes the functional effects of edema on the limb
with impairment of one, two, or three major joints (Figs. 12.1–12.5). This aspect
also permits better definition of the commitments of global functional rehabilitation, the degree of care needed by the patient and the impairment in “Daily Living
Activities.” (Table 12.5). This classification thus utilizes both clinical and functional
criteria for patient assessment.
9
It should be emphasized, however, that the new Brazilian proposal addresses
deficiencies that have been recognized in other stages so far presented.
The respective positions of the “experts” at such a delicate and transitional
moment for both public and private health systems in different countries also stems
from the need to redefine welfare parameters for these highly prevalent diseases.10
At more advanced stages of disease, in fact, we can identify the extremes of a true
social disease for which the health system must provide incentives and normative
facilitations comparable to the other diseases for which such benefits and advantages are provided.
92 S. Michelini et al.
Fig. 12.1 Lymphedema
stage 0 (pre-clinical)
Fig. 12.2 Lymphedema stage I
(involvement of one major joint)
12 Clinical Staging
Fig. 12.3 Stage II (involvement of two
major joints of the limb)
93
It is pointless to say that, currently, many National Healthcare Systems provide
therapies to patients with both primary and secondary lymphedema in an inequitable manner, with poor distribution of healthcare resources. In most countries, the
costs of materials, elastic garments and phlebo-lymph-active drugs are charged to
the patient.
Thus, it is essential to solve these problems in each country at a governmental
level. Epidemiological studies are still insufficient and must be updated in order to
better define a problem that for too long has been totally ignored, while the number
of patients affected is increasing daily.
It should also be noted that the various staging criteria examined take into account
only aspects of the organic and physical involvement of the patients; yet, the variable emotional and psychological involvement, in some cases, regardless of the
clinical evolution, the age, or the socio-economic and cultural condition of the
patient, assumes greater functional significance. These factors that, over time, have
a more profound influence on behavior, personal performance, and social relationships, and reinforce the simple physical problem, are overlooked in the staging
schemes.
94 S. Michelini et al.
Fig. 12.4 Stage III (involvement of
three major joints of the limb)
Fig. 12.5 Stage IV
(cutaneous infections and
inflamatory complications of
the limb)
12 Clinical Staging
Table 12.5 Staging according to the Brazilian Society of Lymphology (Prof. M. Andrade)
Clinical stage Evidence
0 (Fig. 12.1) No edema in individuals at risk (pre-clinical)
I (Fig. 12.2) Edema that regresses spontaneously with elevation, pitting ++, Stemmer +,
involvement of one major joint of the limb
II (Fig. 12.3) Edema that does not regress spontaneously, only with treatments, pitting +,
Stemmer ++, involvement of at least two major joints of the limb
III (Fig. 12.4) Edema that does not regress spontaneously, only with treatments, pitting +,
Stemmer ++, involvement of three major joints of the limb
IV (Fig. 12.5) Edema that does not regress spontaneously, only with treatments, pitting +,
Stemmer ++, involvement of three major joints of the limb, with cutaneous
infections
95
References
1. International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema.
Consensus document of the International Society of Lymphology. Lymphology. 2003;36:
84-91.
2. Michelini S, Failla A. Linfedemi: inquadramento diagnostico clinico e strumentale. Minerva
Cardioangiol. 1997;45(6 suppl I):11-15.
3. Michelini S, Campisi C, Ricci M, et al. Linee Guida Italiane sul Linfedema. Eur Med Phys.
2007;43(suppl 1–3):34-41.
4. Campisi C, Michelini S, Boccardo F. Guidelines of the Società Italiana di Linfangiologia.
Lymphology. 2004;37(4):174-179.
5. Campisi C, Michelini S, Boccardo F. Lymphology in medical and surgical practice. Italian
guidelines looking towards Europe and World. Eur J Lymphol. 2004;14(42):26-28.
6. World Health Organization. International Classification of Functionng, Disability and Health.
Geneva: WHO; 2001.
7. Campisi C, Michelini S, Boccardo F, Zilli A, Borrelli V. Modern stadiation of lymphedema
and corresponding preventive options. Eur J Lymphol. 1999;7(25):27-31.
8. Ohkuma M. In lymphedema-related acute dermatitis. Abstract book of XX Congress of
International Society of Lymphology. Sociedade Brasileira de Linfologia. Salvador Bahia;
September 2005: 46.
9. Michelini S, Campisi C, Failla A, et al. Staging of lymphedema: comparing different propos-
als. Eur J Lymphol. 2006;16(46):7-10.
10. Tretbar LL, Morgan CL, Lee BB, Simonian SJ, Blondeau B. Lymphedema Diagnosis and
Treatment. London: Springer; 2008.
11. Foldi M, Foldi E, Kubik S. Foldi’s Textbook of Lymphology. Munchen: Elsevier; 2004.
Chapter 13
Combined Clinical and Laboratory
(Lymphoscintigraphic) Staging
Byung-Boong Lee, James Laredo, and Richard F. Neville
Accurate assessment and clinical staging of patients with chronic lymphedema
remains the most reliable objective methods of classifying patients for proper treatment and management.
The clinical staging proposed by the International Society of Lymphology (ISL)
over the last decade has remained the most popular staging system despite widespread dissatisfaction with its crude approach based on clinical, mostly physical
findings alone.
3,4
This ISL-recommended (clinical) staging system was initially proposed as part
of a general consensus on the diagnosis and management of peripheral edema based
on the old concept that failed to incorporate the new concept proposed during the
recent update of the ISL consensus.
Throughout the last decade, the concept of chronic lymphedema has undergone
significant change; chronic lymphedema is no longer considered to be a “static”
condition of simple lymph fluid stasis. It is now believed to be an ever-changing
condition affecting the entire soft tissue, well beyond the lymphatic system.
Current ISL staging is still far too simple. Appropriate staging is required to
develop a complicated treatment strategy. Accurate staging of chronic lymphedema
is critical when reconstructive or ablative surgical therapy is considered as a supplement in a patient who has failed to respond to complex decongestive therapy
9,10
(CDT).
Appropriate timing of this surgical option is critical.
Therefore, improved staging with new advanced diagnostic assessment is
required for close monitoring of the disease process. This is especially true not only
for general management of lymphedema, but also for determining the need for surgical implementation.
Various noninvasive to minimally invasive tests (e.g., radionuclide lymphoscintigraphy)
12-15
1,2
5,6
7,8
7,11
have been developed over the last decade to better assess the
B.-B. Lee (*)
Department of Surgery, Division of Vascular Surgery,
George Washington University School of Medicine, Washington, DC, USA
B.-B. Lee et al. (eds.), Lymphedema,
DOI 10.1007/978-0-85729-567-5_13, © Springer-Verlag London Limited 2011
97
98 B.-B. Lee et al.
Table 13.1 Quality of life (QOL)
Excellent No limitation or difficulty with extra activity (e.g., hobby) physically, psychologi-
Good Some limitation of extra activity, but occasionally, physically, psychologically, and/
Fair Significant limitation of extra activity, but no limitation of daily activity physically,
Poor Significant limitation of both daily activity and extra activity, frequently physically,
Bad Profound limitation of daily activity as well as extra activity or no daily activity
cally, and/or socioeconomically in addition to daily activity
or socioeconomically, but with no limitation of daily activity
psychologically and/or socioeconomically, or occasionally some limitation of
both daily and extra activity
psychologically, and/or socioeconomically
feasible without assistance physically, psychologically, and/or
socioeconomically
progression of the lymphedema and allow better treatment and prevention of complications associated with chronic lymphedema (e.g., infection).
Advances in diagnosis and clinical staging have allowed assessment of patient
quality of life (QoL)
agement of lymphedema
16,17
(Table 13.1). The ultimate goal of the contemporary man-
7,11
is to improve the QoL by allowing better social interac-
tion and improved functional and psychological well being.
New laboratory data have never been fully incorporated in a manner that might
improve the traditional treatment approach, which is solely based on clinical judgment. Currently available staging methods for assessing treatment outcome and progression of lymphedema are still dependent on this “clinical” staging alone and fail
to reflect all aspects of the chronic lymphedema.
18,19
Therefore, we have developed a new staging system that includes laboratory data
for better assessment of the dynamic, ever-changing status of chronic lymphedema
beyond the limits of “clinical” staging.
1,2
Initially, we attempted to incorporate lymphoscintigraphic data of chronic lymphedema patients into the conventional clinical–ISL–staging system. Integrating
the clinical findings with those of laboratory findings (e.g., radionuclide lymphoscintigraphy) was too complicated and, in cases in which a significant mismatch
between clinical and laboratory findings was observed, more confusion was added
to the staging system.
We therefore proposed two separate staging systems, one clinical and the other
using laboratory (lymphoscintigraphy) data. Together, these two staging systems
classify the clinical manifestation and/or progress of the lymphedema more precisely based on two independent criteria (Table 13.2).
The new clinical staging classifies the clinical manifestation and progression of lymphedema using a four-stage system (clinical stages I through IV). Systemic and local
clinical conditions associated with lymphedema are included along with QoL measures.
The limitations of the ISL system (three stages) based on clinical data, mostly local
factors (edema and skin change), are by and large now fully compensated for by the
inclusion of various systemic factors including sepsis, daily activity limitation, and
QoL parameters – physical, functional, socioeconomic, and psychological, in addition
to the lymphedema, making the staging system more appropriate (four stages).
20,21