Protocol applies to all carcinomas of the vagina.
Procedures
• Cytology
• Biopsy
This protocol is intended to assist pathologists in
providing clinically useful and relevant information as a result of the
examination of surgical specimens. Use of this protocol is intended to be
entirely voluntary. If equally valid protocols or similar documents are
applicable, the pathologist is, of course, free to follow those authorities.
Indeed, the ultimate judgment regarding the propriety of any specific procedure
must be made by the physician in light of the individual circumstances
presented by a specific patient or specimen.
It should be understood that adherence to this
protocol will not guarantee a successful result. Nevertheless, pathologists are
urged to familiarize themselves with the document. Where a physician chooses to
deviate from the protocol based on the circumstances of a particular patient or
specimen, the physician is advised to make a contemporaneous written notation
of the reason for the procedure followed.
The College recognizes that this document may be
used by hospitals, attorneys, managed care organizations, insurance carriers,
and other payers. However, the document was developed solely as a tool to
assist pathologists in the diagnostic process by providing information that
reflects the state of relevant medical knowledge at the time the protocol was
first published. It was not developed for credentialing, litigation, or
reimbursement purposes. The College cautions that any uses of the protocol for
these purposes involve considerations that are beyond the scope of this
document.
I. Cytologic material back Top Main Page
A. Clinical information
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) pregnancy
(2) uterine bleeding pattern if abnormal
(3) discharge per vaginam
(4) previous therapy [e.g. hormonal, radiation,
chemotherapy]
(5) prenatal exposure to diethylstilbestrol (DES)
or related synthetic drugs (Note A)
(6) previous tumors and operations of possible
relevance (Note B)
b. Relevant findings (e.g. radiologic studies,
laboratory data, other) (Note C)
c. Clinical diagnosis
d. Operative findings
e. Procedure (e.g. vaginal pool aspiration,
scraping of vaginal surface, fine needle aspiration)
f. Type(s) or site(s) of specimen(s)
B. MACROSCOPIC EXAMINATION
1. Specimen
a. Unfixed/fixed (specify fixative)
b. Number of slides received, if appropriate
c. Other (e.g. cytologic preparation from
tissue)
d. Results of intraprocedural consultation
2. Material submitted for microscopic evaluation
(e.g. smear; touch preparation)
3. Special studies (specify) (e.g. immunocytochemistry)
C. MICROSCOPIC
EVALUATION
1. Adequacy of specimen (if unsatisfactory for
evaluation, specify reason)
2. Tumor, if present (Note D)
a. Histologic type, if possible (Note
E)
b. Other characteristics, as pertinent
3. Additional cytologic findings, if present
4. Results /status of special studies (specify)
5. Comments
a. Correlation with intraprocedural
consultation, as appropriate
b. Correlation
with other specimens, as appropriate
c. Correlation with clinical information, as
appropriate
II. Biopsy (incisional or
excisional) back Top Main Page
A. CLINICAL INFORMATION
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) pregnancy
(2) uterine bleeding pattern if abnormal
(3) discharge per vaginam
(4) previous therapy [e.g. hormonal, radiation,
chemotherapy]
(5) prenatal exposure to diethylstilbestrol (DES)
or related synthetic drugs (Note A) of possible relevance (Note B)
b. Relevant findings (e.g. radiologic studies,
laboratory data, other) (Note C)
c. Clinical diagnosis
d. Operative findings
e. Procedure (e.g. excisional biopsy, needle
biopsy)
f. Type(s) or site(s) of specimen(s) (e.g.
apex, anterior, posterior, lateral wall, upper, middle, lower third)
B. MACROSCOPIC EXAMINATION
1. Specimen
a. Unfixed/fixed (specify fixative)
b. Number of pieces
c. Size or size range
d. Descriptive features
e. Orientation if designated by surgeon
f. Results of intraoperative consultation
2. Tumor
a. Dimensions (if appropriate)
b. Descriptive features
3. Margins (if pertinent)
4. Other lesions, if present
5. Submit entire specimen for microscopic
evaluation unless otherwise indicated
6. Special studies ( specify)
C. MICROSCOPIC EVALUATION
1. Tumor
a. Histologic type (Note E)
b. Histologic grade (Note F)
c. Extent including resection margins if
pertinent
d. Other features of possible prognostic or
therapeutic significance (Note G)
2. Additional pathologic findings, if present
(specify) and relation to tumor, if pertinent (Note H)
a. Dysplasia
b. Carcinoma in situ
c. Condyloma acuminatum
d. Adenosis
e. Other(s)
3. Results/status of special studies (specify)
4. Comments
a. Correlation with intraoperative consultation,
as appropriate
b. Correlation with other specimens, as
appropriate
c. Correlation with clinical information, as
appropriate
III. Vaginectomy back Top Main Page
A. CLINICAL INFORMATION
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) pregnancy
(2) uterine bleeding pattern if abnormal
(3) discharge per vaginam
(4) previous therapy [e.g. hormonal, radiation,
chemotherapy]
(5) prenatal exposure to diethylstilbestrol (DES)
or related synthetic drugs (Note A)
(6) previous tumors and operations of possible
relevance (Note B)
b. Relevant findings (e.g. radiologic studies,
laboratory data, other) (Note C)
c. Clinical
diagnosis
d. Operative findings
e. Procedure (e.g. partial vaginectomy)
f. Type(s) or site(s) of specimens
B. MACROSCOPIC EXAMINATION
1. Specimen
a. Organ/tissue(s) received
b. Fixed/unfixed (specify fixative)
c. Number of pieces
d. Size (length/circumference/thickness)
e. Orientation (if indicated by surgeon)
f. Descriptive features (inner and outer
surfaces; wall)
g. Results of intraoperative consultation
2. Tumor
a. Size
b. Descriptive features
3. Margins (if pertinent)
4. Additional pathologic findings, if present
5. Tissue(s) submitted for microscopic
evaluation
6. Special studies (specify) (e.g. staining with
Schiller’s or Lugol’s solution) (Note I)
c. MICROSCOPIC EXAMINATION
1. Tumor
a. Histologic type (Note E)
b. Histologic grade (Note F)
c. Extent of invasion (Note J)
d. Resection margins
e. Other features of possible prognostic or
therapeutic significance (Note G)
2. Additional pathologic findings, if present
and relation to tumor, if pertinent (Note K)
a. Dysplasia
b. Carcinoma in situ
c. Condyloma acuminatum
d. Adenosis
e. Other(s)
3. Results/status of special studies
4. Comments
a. Correlation with intraoperative consultation,
as appropriate
b. Correlation with other specimens, as
appropriate
c. Correlation with clinical information, as
appropriate
(hysterectomy, unilateral or bilateral
salpingo-oophorectomy, lymphadenectomy,
removal of other organs and tissues) back Top Main Page
A. CLINICAL INFORMATION
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) pregnancy
(2) uterine bleeding pattern if abnormal
(3) discharge per vaginam
(4) previous therapy [e.g.hormonal, radiation,
chemotherapy]
(5) prenatal exposure to diethylstilbestrol (DES) or
related synthetic drugs (Note A)
(6) previous tumors and operations of possible
relevance(Note B)
b. Relevant findings (e.g. radiologic studies,
laboratory data, other) (Note C)
c. Clinical diagnosis
d. Operative findings
e. Procedure
f. Type(s) or site(s) of specimen(s):
B. MACROSCOPIC EXAMINATION
1. Specimen
a. Organs/tissues received
b. Unfixed/fixed (specify fixative)
c. Measurements (if appropriate)
d. Orientation (if indicated by surgeon)
e. Results of intraoperative consultation
2. Vagina
a. Size (length, circumference, thickness)
b. Descriptive features (inner/outer surfaces,
wall)
c. Tumor
(1) size
(2) descriptive features
d. Resection margins if pertinent
e. Additional pathologic findings, if present
3. Uterine cervix
a. Descriptive features (Note K)
(1) appearance of ectocervix
(2) appearance of endocervix
b. Tumor, if present
(1) descriptive features
(2) size
(3) extent
(4) relation to main tumor
c. Additional pathologic findings, if
present (specify)
4. Uterine corpus
a. Descriptive features of endometrium,
myometrium and serosa
b. Tumor,
if present
(1) measurements
(2) location
(3) relation to main tumor
c. Additional pathologic findings, if present
(specify)
5. Fallopian tube(s) (Note L)
a. Descriptive features, including measurements
b. Tumor, if present
(1) measurements
(2) location
(3) relation to main tumor
c. Additional pathologic findings, if present
(specify)
6. Ovary or ovaries
a. Descriptive features
(1) outer surface
(2) sectioned surfaces
b. Dimensions
c. Tumor, if present
(1) measurements
(2) location
(3) relation to main tumor
d. Additional pathologic findings, if present
(specify)
7. Regional lymph nodes
a. Number and size range at each designated
location
b. Tumor, if present
(1) size
(2) descriptive features
c. Additional pathologic findings, if present
(specify)
8. Other organ (s) or tissue(s) removed
a. Type(s)
b. Dimensions
c. Descriptive features
d. Tumor, if present
(1) measurements
(2) location
(3) relation to main tumor
e. Other features of possible prognostic or
therapeutic significance (Note G)
9. Tissues submitted for microscopic evaluation
(specify)
10. Special studies (specify)
C. MICROSCOPIC EVALUATION
1. Vagina
a. Tumor
(1) histologic type (Note E)
(2) histologic grade (Note F)
(3) extent of invasion (Note J)
(4) other features of possible prognostic or
therapeutic significance (Note G)
b. Status of resection margins
c. Additional pathologic findings, if present
and relation to tumor, if pertinent (Note H)
(1) dysplasia
(2) carcinoma in situ
(3) condyloma acuminatum
(4) adenosis
2. Uterine cervix
a. Tumor, if present
(1) histologic type (Note E)
(2) histologic grade (Note F)
(3) extent of invasion
(4) location and relation to vaginal tumor
b. Additional pathologic findings, if present
and relation to tumor, if pertinent
(1) dysplasia
(2) carcinoma in situ
(3) condyloma acuminatum
3. Uterine corpus
a. Tumor, if present
(1) histologic type (Note E)
(2) histologic grade (Note F)
(3) location and relation to vaginal tumor
b. Additional pathologic findings, if present
and relation to tumor, if pertinent
c. Portion uninvolved by tumor
4. Fallopian tube(s)
a. Tumor, if present
(1) histologic type (Note E)
(2) histologic grade (Note F)
(3) location and relation to vaginal tumor
b. Additional pathologic findings, if
present
5. Ovary /ovaries
a. Tumor, if present
(1) histologic type (Note E)
(2) histologic grade (Note F)
(3) location and relation to vaginal tumor
b. Additional pathologic findings, if present
6. Regional lymph nodes (Note J)
a. Location (if designated)
b. Tumor, if present
(1) histologic type, if different from main tumor
(2) histologic grade, if different from main tumor
c. Additional pathologic findings, if present
7. Other organ(s) or tissue(s) removed
a. Tumor, if present (Note J)
(1) location, distribution, and extent
(2) histologic type, if different from main tumor
(3) histologic grade, if different from main tumor
b. Resection margins if applicable
c. Additional pathologic findings, if present
8. Results/status of special studies (specify)
9. Comments
a. Correlation with intraoperative consultation,
as appropriate
b. Correlation with other specimens, as
appropriate
c. Correlation with clinical information, as
appropriate
EXPLANATORY NOTES
A. Prenatal
DES Exposure back Top Main Page
Prenatal exposure to diethylstilbestrol (DES) or
related synthetic drugs were relatively common in the United States and other
countries until 1971, when its relation to clear cell adenocarcinomas of the
vagina and cervix led to proscription of these drugs by the Food and Drug
Administration. A history of this type of prenatal drug exposure should alert
the pathologist to the possible presence of those tumors and associated
lesions.(1-3)
B. Prior
Tumors and Operations back Top Main Page
A history of dysplasia, carcinoma in situ or invasive
carcinoma of the cervix as well as knowledge of its microscopic features may be
essential in the determination whether a subsequent vaginal tumor is a
recurrent or new tumor. Also, a history of a carcinoma even higher in the
female genital tract may influence the interpretation of a neoplasm that is
detected in a specimen of the vagina. Prior pathology slides and reports should
be obtained and reviewed if a review is deemed essential by the clinician or
pathologist for optimal pathologic evaluation of the present specimen.
C. Clinical
Findings and DES Exposure back Top Main Page
Naked-eye examination, colposcopy, and iodine
staining of the cervix and vagina may disclose a variety of changes highly
suspicious of prenatal DES exposure, such as cervical hypoplasia, pseudopolyp,
or coxcomb deformity, and vaginal adenosis or ridge, any of which should alert
the pathologist to examine carefully for DES changes.
D. Bethesda
Classification System of Cervical/Vaginal Cytology back Top Main Page
For consistency in reporting, the cytologic
classification proposed in The Bethesda System is recommended.(4)
This protocol does not preclude the use of other systems of classification; the
Papanicolaou class designation system, however, is not recommended.
Cervical/Vaginal Cytology Classification (The Bethesda System)
SPECIMEN
ADEQUACY
·
Satisfactory for evaluation (describe
presence or absence of endocervical/transformation zone component and any other
quality indicators, e.g., partially obscuring blood, inflammation, etc.)
·
Unsatisfactory for evaluation ... (specify reason)
·
Specimen rejected/not processed (specify
reason)
·
Specimen processed and examined, but
unsatisfactory for evaluation of epithelial abnormality because of (specify
reason)
GENERAL CATEGORIZATION
(optional)
·
Negative for Intraepithelial Lesion or Malignancy
·
Epithelial Cell Abnormality: See
Interpretation/Result (specify ‘squamous’ or ‘glandular’ as appropriate)
·
Other: See Interpretation/Result (e.g.
endometrial cells in a woman ³ 40 years of
age)
AUTOMATED REVIEW
If case examined by automated device,
specify device and result.
ANCILLARY TESTING
Provide a brief description of the test
methods and report the result so that it is easily understood by the clinician.
DESCRIPTIVE
INTERPRETATIONS/DIAGNOSES
NEGATIVE FOR INTRAEPITHELIAL LESION OR
MALIGNANCY (when there is no cellular evidence of
neoplasia, state this in the General Categorization above and/or in the
Interpretation/Result section of the report, whether or not there are organisms
or other non-neoplastic findings)
ORGANISMS:
·
Trichomonas vaginalis
·
Fungal organisms morphologically consistent with
Candida spp
·
Shift in flora suggestive of bacterial vaginosis
·
Bacteria morphologically consistent with Actinomyces
spp.
·
Cellular changes consistent with Herpes simplex
virus
OTHER NON NEOPLASTIC FINDINGS (Optional to
report; list not inclusive):
·
Reactive cellular changes associated with
·
inflammation (includes typical repair)
·
radiation
·
intrauterine contraceptive device (IUD)
·
Glandular cells status post hysterectomy
·
Atrophy
OTHER
·
Endometrial cells (in a woman ³
40 years of age)
(Specify if ‘negative for squamous intraepithelial lesion’)
EPITHELIAL CELL ABNORMALITIES
SQUAMOUS CELL
·
Atypical squamous cells
·
of undetermined significance (ASC-US)
·
cannot exclude HSIL (ASC-H)
·
Low grade squamous intraepithelial lesion (LSIL)
encompassing:
HPV/mild dysplasia/CIN 1 *
·
High grade squamous intraepithelial lesion
(HSIL)
encompassing:
moderate and severe dysplasia, CIS/CIN 2 and CIN 3
·
with features suspicious for invasion (if
invasion is suspected)
·
Squamous cell carcinoma
GLANDULAR CELL
·
Atypical
·
endocervical cells (NOS or specify in
comments)
·
endometrial cells (NOS or specify in comments)
·
glandular cells (NOS or specify in comments)
·
Atypical
·
endocervical cells, favor neoplastic
·
glandular cells, favor neoplastic
·
Endocervical adenocarcinoma in situ
·
Adenocarcinoma
·
endocervical
·
endometrial
·
extrauterine
·
not otherwise specified (NOS)
OTHER MALIGNANT NEOPLASMS: (specify)
*Cellular changes of HPV cytopathic effect,
previously termed “koilocytosis,” “koilocytotic atypia,” or “condylomatous atypia,”
are included in the category of LSIL.
E. Histologic
Type back Top Main Page
The World Health Organization (WHO) classification
and nomenclature of vaginal tumors is recommended because of its wide
acceptance.
WHO Classification
Precancerous Lesions and Carcinomas of the Vagina
(Modified)
Squamous Vaginal intraepithelial
intraepithelial lesions neoplasia (VAIN)
Mild dysplasia 1
Moderate dysplasia 2
Severe dysplasia 3
Carcinoma in situ 3
Squamous cell carcinoma
Keratinizing
Non-keratinizing
Verrucous
Warty
(condylomatous)
Atypical adenosis
Adenocarcinoma
Clear
cell
Endometrioid
Mucinous
Endocervical
type
Intestinal
type
Mesonephric
Adenosquamous carcinoma
Adenoid cystic carcinoma
Adenoid basal carcinoma
Carcinoid tumor
Small cell carcinoma
Undifferentiated carcinoma