Protocol applies to all carcinomas of the stomach.
Procedures
• Cytology
• Incisional Biopsy (endoscopic or other)
• Gastrectomy (partial or complete)
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)
d. Gender
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) previous diagnoses and treatment for gastric cancer
(2) previous Billroth procedure
(3) Helicobacter pylori gastritis
(4) atrophic gastritis
b. Relevant findings (e.g. endoscopic/imaging studies)
c. Clinical diagnosis
d. Procedure (e.g. brushing, washing, other)
e. Anatomic site(s) of specimen(s)
B. MACROSCOPIC EXAMINATION
1. Specimen
a. Unfixed/fixed (specify fixative)
b. Number of slides received (if appropriate)
c. Quantity and appearance of fluid specimen (if appropriate)
d. Other (e.g. cytologic preparation from tissue)
e. Results of intraprocedural consultation
2. Material submitted for microscopic evaluation
3. Special studies (specify) (e.g. cytochemistry, immunocytochemistry, DNA analysis [specify type], cytogenetic analysis)
C. MICROSCOPIC EVALUATION
1. Adequacy of specimen (if unsatisfactory for evaluation, specify reason)
2. Tumor, if present
a. Histologic type, if possible (Note A)
b. Histologic grade, if possible (Note B)
c. Other characteristics (e.g. nuclear grade/necrosis)
3. Additional pathologic 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. Incisional biopsy (endoscopic or other) back Top Main Page
A. CLINICAL INFORMATION
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
d. Gender
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) previous diagnoses and treatment for gastric cancer
(2) previous Billroth procedure
(3) Helicobacter pylori gastritis
(4) atrophic gastritis
b. Relevant findings (e.g. endoscopic, imaging studies)
c. Clinical diagnosis
d. Procedure (e.g. endoscopic biopsy)
e. Operative findings
f. Anatomic site(s) of specimen(s)
B. MACROSCOPIC EXAMINATION
1. Specimen
a. Unfixed/fixed (specify fixative)
b. Number of pieces
c. Largest dimension of each piece
d. Results of intraoperative consultation
2. Tissues submitted for microscopic evaluation
a. Submit entire specimen
b. Frozen section tissue fragment(s) (unless saved for special studies)
3. Special studies (specify) (e.g. histochemistry, immunohistochemistry, morphometry, DNA analysis [specify type], cytogenetic analysis)
C. MICROSCOPIC EVALUATION
1. Tumor
a. Histologic type (Note A)
b. Histologic grade (Note B)
c. Extent of invasion
d. Blood/lymphatic vessel invasion
2. Additional pathologic findings, if present
a. Dysplasia
b. Metaplasia
c. Atrophy
d. Gastritis
e. Helicobacter pylori
f. Other(s)
3. Results 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. Excisional biopsy back Top Main Page
(Local excision or polypectomy)
A. CLINICAL INFORMATION
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
d. Gender
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) previous diagnoses and treatment for gastric cancer
(2) previous Billroth procedure
(3) Helicobacter pylori gastritis
(4) atrophic gastritis
b. Relevant findings (e.g. endoscopic/imaging studies)
c. Clinical diagnosis
d. Procedure (e.g. polypectomy)
e. Operative findings
f. Anatomic site(s) of specimen(s)
B. MACROSCOPIC EXAMINATION
1. Specimen
a. Unfixed/fixed (specify fixative)
b. Number of pieces
c. Descriptive features (e.g. color/consistency)
d. Dimensions
e. Layers of stomach present (if grossly discernible)
f. Orientation (if indicated by surgeon)
g. Results of intraoperative consultation
2. Tumor
a. Configuration, if appropriate (Note C)
b. Dimensions (three) (Note D)
c. Distance from closest margin
d. Estimated depth of invasion (Note E)
3. Lesions in noncancerous stomach, if appropriate (e.g. ulcers, polyps, other)
4. Tissue(s) submitted for microscopic evaluation
a. Carcinoma, including
(1) point of deepest penetration
(2) interface with adjacent stomach
(3) margin closest to tumor edge
(4) (if a polyp) apex and stalk in same section (if possible)
b. Frozen section tissue fragment(s) (unless saved for special studies)
5. Special studies (specify) (e.g. histochemistry, immunohistochemistry, morphometry, DNA analysis [specify type], cytogenetic analysis)
C. MICROSCOPIC EVALUATION
1. Tumor
a. Histologic type (Note A)
b. Histologic grade (Note B)
c. Extent of invasion (Note E)
d. Blood/lymphatic vessel invasion (Note F)
e. Perineural invasion (Note G)
2. Carcinoma in a polyp
a. Specify histologic type of polyp
b. Specify presence/absence of invasion of:
(1) muscularis mucosae/submucosa of polyp head
(2) submucosa at base
(3) blood/lymphatic vessels (Note F)
3. Margins
a. Distance from closest mucosal margin and deep margin
b. Presence of metaplasia/dysplasia/adenoma
4. Additional pathologic findings, if present
a. Dysplasia
b. Metaplasia
c. Atrophy
d. Gastritis
e. Helicobacter pylori
f. Other(s)
5. Results/status of special studies (specify)
6. Comments
a. Correlation with intraoperative consultation, as appropriate
b. Correlation with other specimens, as appropriate
c. Correlation with clinical information, as appropriate
IV. Gastric resection back Top Main Page
A. CLINICAL INFORMATION
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
d. Gender
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) previous diagnoses and treatment for gastric cancer
(2) previous Billroth procedure
(3) Helicobacter pylori gastritis
(4) atrophic gastritis
b. Relevant findings (e.g. endoscopic/imaging studies)
c. Clinical diagnosis
d. Procedure (e.g. subtotal gastrectomy, total gastrectomy, other)
e. Operative findings
f. Anatomic site(s) of specimen(s)
B. MACROSCOPIC EXAMINATION
1. Specimen
a. Organ(s)/tissue(s) included
b. Unfixed/fixed (specify fixative)
c. Open/unopened
d. Number of pieces
e. Dimensions (Note H)
f. Length of attached esophagus/duodenum
g. Orientation (if indicated by surgeon)
h. Results of intraoperative consultation
2. Tumor
a. Location (Note I)
b. Configuration (Note C)
c. Dimensions (three) (Note D)
d. Descriptive features (e.g. color/consistency)
e. Ulceration/perforation
f. Distance from margins (Note J)
(1) proximal
(2) distal
(3) radial (soft tissue and/or mesenteric margin(s) closest to deepest tumor penetration)
g. Estimated depth of invasion (Note E)
3. Lesions in noncancerous stomach
a. Ulcers
b. Polyps
c. Other(s)
4. Regional lymph nodes
5. Metastasis to other organ(s) or structure(s)
6. Tissues submitted for microscopic evaluation
a. Carcinoma, including
(1) point of deepest penetration
(2) interface with adjacent stomach
(3) visceral serosa overlying tumor
b. Margins (Note G)
(1) proximal
(2) distal
(3) radial (soft tissue and/or mesenteric margin(s) closest to deepest tumor penetration)
c. All lymph nodes
(1) specify node(s) when labeled by surgeon
d. Other lesions (e.g. polyps/ulcers)
e. Stomach uninvolved by tumor
f. Other tissue(s)/organ(s)
g. Frozen section tissue fragments (unless saved for special studies)
7. Special studies (specify) (e.g. histochemistry, immunohistochemistry, morphometry, DNA analysis [specify type], cytogenetic analysis)
C. MICROSCOPIC EVALUATION
1. Tumor
a. Histologic type (Note A)
b. Histologic grade (Note B)
c. Extent of invasion (Note E)
d. Extension into esophagus or duodenum
e. Blood/lymphatic vessel invasion(Note F)
f. Perineural invasion (Note G)
2. Additional pathologic findings, if present
a. Chronic gastritis (type)
b. Intestinal metaplasia
c. Dysplasia
d. Atrophy
e. Adenoma
f. Other types of polyps
g. Helicobacter pylori
h. Other
3. Margins (Note J)
a. Proximal
b. Distal
c. Radial
4. Regional lymph nodes (Note K)
a. Number
b. Number involved by tumor
5. Distant metastasis (specify site[s]) (Note K)
6. Other tissue(s)/organ(s)
7. Results/status of special studies (specify)
8. 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. Histologic Type back Top Main Page
For consistency in reporting, the histologic classification proposed by the World Health Organization (WHO) is recommended.(1) However, this protocol does not preclude the use of other systems of classification or histologic types, such as the Laurén classification,(2) which may be used in addition to the WHO system.
With the exception of the rare small cell carcinoma of the stomach which has an unfavorable prognosis, most multivariate analyses show no effect of tumor type, independent of stage, on prognosis.(3)
WHO Classification of Carcinoma of the Stomach
• Adenocarcinoma
• Papillary adenocarcinoma*
• Tubular adenocarcinoma
• Mucinous adenocarcinoma (>50% mucinous)
• Signet ring cell carcinoma (>50% signet ring cells)
• Adenosquamous carcinoma
• Squamous cell carcinoma
• Small cell carcinoma
• Undifferentiated carcinoma
• Other (specify)
* Not usually graded (see below).
The Laurén classification, namely intestinal or diffuse type, and/or the Ming classification, namely, expanding or infiltrating type, may also be included. Some pathologists classify in situ carcinoma under the diagnostic term “severe or high-grade, dysplasia.” The term “carcinoma, NOS (not otherwise specified)” is not part of the WHO classification.
B. Histologic Grade back Top Main Page
For adenocarcinomas, a histologic grade is based on the extent of glandular differentiation is suggested as shown below.
Grade X Cannot be assessed
Grade 1 Well differentiated (>95% of tumor composed of glands)
Grade 2 Moderately differentiated (50-95% of tumor composed of glands)
Grade 3 Poorly differentiated (5-49% of tumor composed of glands)
Grade 4 Undifferentiated* (<5% of tumor composed of glands)
Tubular carcinomas are assigned Grade 1.
Signet ring cell carcinomas are assigned Grade 3.
Small cell carcinomas and undifferentiated (histologic type) carcinomas are assigned Grade 4.
For squamous cell carcinomas (rare), a suggested histologic grading system is shown below.
Grade X Grade cannot be assessed
Grade 1 Well differentiated
Grade 2 Moderately differentiated
Grade 3 Poorly differentiated
Grade 4* Undifferentiated
*Undifferentiated tumors cannot be specifically categorized as adenocarcinoma or squamous cell carcinoma. Instead, they are classified as undifferentiated carcinoma by the WHO classification of tumor types (see Note A above).
For all stage groupings, grading correlates with outcome.(4,5)
C. Configuration back Top Main Page
Configuration includes exophytic (polypoid), infiltrative, diffusely infiltrative (linitis plastica), expansile (noninfiltrative), ulcerating, or annular. Exophytic is divided into pedunculated and sessile. For descriptions of complex configurations, more than one descriptor may be used. Tumor configuration has been shown to have prognostic significance in some large studies.(3) However, the prognostic value of tumor configuration is controversial since numerous other studies have failed to demonstrate independent prognostic significance for this pathologic feature.
D. Tumor Size back Top Main Page
Although not a factor in the T classification of gastric carcinoma (see Note E below), tumor size has been shown to be an independent adverse prognostic factor in many studies.(3) However, the prognostic value of tumor size is controversial since a large number of other studies have failed to demonstrate independent prognostic significance for this pathologic feature.
E. TNM and Stage
Groupings back Top Main Page
The
TNM Staging System for gastric carcinoma of the American Joint Committee on
Cancer (AJCC) and the International Union Against Cancer (AJCC) is recommended
and shown below.(6,7)
By
AJCC/UICC convention, the designation “T” refers to a primary tumor that has
not been previously treated. The symbol “p” refers to the pathologic
classification of the TNM, as opposed to the clinical classification and is based
on gross and microscopic examination.
pT entails a resection of the primary tumor or biopsy adequate to
evaluate the highest pT category; pN entails removal of nodes adequate to
validate lymph node metastasis; and pM implies microscopic examination of
distant lesions. Clinical
classification (cTNM) is usually carried out by the referring physician before
treatment during initial evaluation of the patient or when pathologic
classification is not possible.
Residual
Tumor in the Patient
Tumor
remaining in a patient after therapy with curative intent (e.g., surgical
resection for cure) is categorized by a system known as R classification, shown
below.
RX Presence of residual tumor cannot be
assessed
R0 No residual tumor
R1 Microscopic residual tumor
R2 Macroscopic residual tumor.
For
the surgeon, the R classification may be useful to indicate the known or
assumed status of the completeness of a surgical excision. For the pathologist, the R classification is
relevant to the status of the margins of a surgical resection specimen. That is, tumor involving the resection
margin on pathologic examination may be assumed to correspond to residual tumor
in the patient and may be classified as macroscopic or microscopic according to
the findings at the specimen margin(s).
Residual
Tumor in a Specimen
In
contrast, tumor remaining in a resection specimen from a patient who has
undergone previous (neoadjuvant) treatment of any type (radiation therapy
alone, chemotherapy therapy alone, or any combined modality treatment) is
codified by the TNM using a prescript “y” (e.g., ypT1). Thus, yTNM indicates the post-treatment
status of the tumor. For many
neoadjuvant therapies, the classification of residual disease may be a strong
predictor of postoperative outcome. In
addition, the ypTNM classification provides a standardized framework for the
collection of data needed to accurately evaluate new neoadjuvant therapies.
Locally
Recurrent Tumor
In
contrast to “residual” tumor, classification of a tumor as “recurrent” requires
a documented disease-free interval after definitive therapy. Recurrent tumor may also be classified
according to the TNM categories, but the prefix “r” (e.g., rpT1) is used to
indicate the recurrent status of the tumor.
Primary Tumor (T)
TX Primary tumor cannot be assessed
T0 No evidence of primary tumor
Tis Carcinoma in situ: intraepithelial tumor
without invasion of the lamina propria
T1* Tumor invades
lamina propria or submucosa
T1a Tumor
invades lamina propria (mucosa)
T1b Tumor
invades submucosa
T2* Tumor invades muscularis propria or
subserosa
T2a Tumor
invades muscularis propria
T2b Tumor
invades subserosa
T3 Tumor penetrates serosa (visceral
peritoneum) without invasion of adjacent structures**
T4 Tumor directly invades adjacent
structures***
*Optional
expansions of T1 and T2 are provided for those desiring more detail.(8) Separation of T1 into T1a and T1b is
justified for the following reasons: 1) the frequency of lymph node metastasis
is greater for T1b than for T1a; 2) treatment approaches may differ.(15) Separation of T2 into T2a and T2b is
justified because post-surgical survival following resection for cure has been
shown to be significantly different for T2a and T2b (see below):(8)
** A
tumor may penetrate the muscularis propria with extension into the gastrocolic
or gastrohepatic ligaments or into the greater or lesser omentum without
perforation of the visceral peritoneum covering these structures. In this case the tumor would be classified
as T2. If there is perforation of the visceral peritoneum covering the gastric
ligaments or omenta, the tumor is classified as T3.
***The
adjacent structures of the stomach are the spleen, transverse colon, liver,
diaphragm, pancreas, abdominal wall, adrenal gland, kidney, small intestine,
and retroperitoneum. Intramural extension
into the duodenum or esophagus is classified by the depth of greatest invasion
in any of these sites, including the stomach.
Regional Lymph Nodes
(N) (also see Note K below)
NX Regional lymph nodes cannot be
assessed
N0 No regional lymph node metastasis
N1 Metastasis in 1-6 perigastric lymph nodes
N2 Metastasis in 7-15 perigastric lymph
nodes
N3 Metastasis in more than 15 lymph nodes
Distant Metastasis (M)
MX Presence of distant metastasis cannot be
assessed
M0 No distant metastasis
M1 Distant metastasis
Stage Groupings
Stage 0 Tis N0 M0
Stage IA T1 N0 M0
Stage 1B T1 N1 M0
T2 N0 M0
Stage II T1 N2 M0
T2 N1 M0
T3 N0 M0
Stage IIIA T2 N2 M0
T3 N1 M0
T4 N0 M0
Stage IIIB T3 N2 M0
Stage IV T4 N1,N2,N3 M0
T1,T2,T3 N3 M0
Any T Any N M1Regional Lymph
Nodes (N) (also see Note K below)
NX Regional lymph nodes cannot be assessed
N0 No regional lymph node metastasis
N1 Metastasis in 1-6 perigastric lymph nodes
N2 Metastasis in 7-15 perigastric lymph
nodes
N3 Metastasis in more than 15 lymph nodes
Distant Metastasis (M)
MX Presence of distant metastasis cannot be
assessed
M0 No distant metastasis
M1 Distant metastasis
Stage Groupings
Stage 0 Tis N0 M0
Stage IA T1 N0 M0
Stage 1B T1 N1 M0
T2 N0 M0
Stage II T1 N2 M0
T2 N1 M0
T3 N0 M0
Stage IIIA T2 N2 M0
T3 N1 M0
T4 N0 M0
Stage IIIB T3 N2 M0
Stage IV T4 N1,N2,N3 M0
T1,T2,T3 N3 M0
Any
T Any
N M1
F. Blood/Lymphatic Vessel Invasion back Top Main Page
Both venous and lymphatic vessel invasion have been shown to be adverse prognostic factors.9 However, the microscopic presence of tumor in lymphatic vessels or veins does not qualify as local extension of tumor as defined by the T classification (see Note E above).(8)
G. Perineural Invasion back Top Main Page
Perineural invasion has been shown to be an adverse prognostic factor.(3)
H. Specimen Dimensions back Top Main Page
Open specimen along greater curvature, avoiding tumor if located in this position. Measure length of stomach along lesser curvature and circumference of distal margin. Measure length and width of tubular esophagus.
I. Tumor Location back Top Main Page
Tumor location should be described in relation to the following landmarks:
• gastric region: cardia (including gastroesophageal junction), fundus, corpus, antrum, pylorus
• greater curvature, lesser curvature
• anterior wall, posterior wall
For tumors involving the gastroesophageal junction, specific observations should be recorded in an attempt to establish the exact site of origin of the tumor. The gastroesophageal junction is defined as the junction of the tubular esophagus and the stomach irrespective of the type of epithelial lining of the esophagus. The pathologist should record the:
1) proportion of tumor mass located in the esophagus and stomach
2) greatest dimensions of esophageal and gastric portions of the tumor
3) anatomic location of the center of the tumor
If more than 50% of the tumor involves the esophagus, the tumor is classified as esophageal. If more than 50% of the tumor involves the stomach, the tumor is classified as gastric.(8) If the tumor is equally located above and below the gastroesophageal junction and/or is designated as being at the junction (anatomic center of the tumor), carcinomas of the squamous, small cell, and undifferentiated types are classified as esophageal, whereas adenocarcinomas and signet ring cell carcinomas are classified as gastric.(8)
Tumor site has been shown to be an independent prognostic factor in gastric carcinoma. The long-term prognosis for patients with proximal carcinomas (i.e. tumors of the upper third of the stomach, including the gastric cardia and gastroesophageal junction) is poorer than for those with distal cancers.(3)
Margins include the proximal, distal, and radial margins. The radial margin represents the nonperitoneal soft tissue margin closest to the deepest penetration of tumor. In the stomach, the mesenteric resection margin is the only radial margin. It may be helpful to mark the margin(s) closest to the tumor with ink. Margins marked by ink should be designated in the macroscopic description.
K. Regional Lymph Nodes back Top Main Page
Regional lymph nodes include:(6)
• perigastric nodes along the lesser and greater curvatures
• nodes located along the left gastric, common hepatic, hepatoduodenal, splenic, and celiac arteries
Involvement of other intra-abdominal lymph nodes, such as hepatoduodenal, retropancreatic, mesenteric, and para-aortic is classified as distant metastasis.(9)
1. Watanabe H, Jass JR, Sobin LH. Histological typing of esophageal and gastric tumours. WHO International Histological Classification of Tumours. 2nd ed. Berlin-New York: Springer-Verlag; 1991.
2. Lauren P. The two histological main types of gastric carcinoma. Acta Pathol Microbiol Scand. 1965;64:31-49.
3. Hermanek P, Maruyama K, Sobin LH. Stomach Carcinoma. In: Hermanek P, Gospodarowicz M, Henson DE, et al, eds. Prognostic Factors in Cancer. Berlin-New York: Springer-Verlag; 1995.
4. Rohde H, Gebbensleben P, Bauer P, Stützer H, Zieschang J. Has there been any improvement in the staging of stomach cancer? Findings from the German Gastric Cancer TNM Study Group. Cancer. 1989;64:2465-2481.
5. Carriaga MT, Henson DE. The histologic grading of cancer. Histology of Cancer, Incidence, and Prognosis, SEER Population-Based Data, 1973-1987. Cancer. 1995;75:406-421.
6. Fleming ID, Cooper JS, Henson DE, et al., eds. AJCC Manual for Staging of Cancer. 5th ed. Philadelphia, PA: Lippincott Raven; 1997.
7. Sobin LH, Wittekind C, eds. TNM Classification of Malignant Tumours: International Union Against Cancer. 5th ed. New York, NY: Wiley; 1997.
8. Hermanek P, Henson DE, Hutter RVP, Sobin LH. TNM Supplement. Berlin-New York, NY: Springer-Verlag; 1993.
9. Bunt AM, Hogendoorn PC, van de Velde CJ, Bruijn JA, Hermans J. Lymph-node staging standards in gastric cancer. J Clin Oncol. 1995;13:2309-2316.
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Authors:
Carolyn Compton, MD, PhD; Leslie H. Sobin, MD
©2000. College of American Pathologists (CAP). All rights reserved. None of the contents of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission of the publisher.
Originally published in the Archives of Pathology & Laboratory Medicine, January 1998.
Contributors: back Top Main Page
CAP Cancer Committee; Donald Antonioli, MD; Harvey Goldman, MD; Rodger C. Haggitt, MD; Robert V. P. Hutter, MD; J. Milburn Jessup, MD; Randall Lee, MD; Klaus Lewin, MD; Pablo Ross, MD; Heidrun Rotterdam, MD; Stuart Spechler, MD; Miriam E. Vincent, MD; Christopher Willett, MD; Donald E. Henson, MD