Endoscopic mucosal tissue sampling.
General
Guideline Title
Endoscopic mucosal tissue sampling.
Bibliographic Source(s)
- ASGE Standards of Practice Committee, Sharaf RN, Shergill AK, Odze RD, Krinsky ML, Fukami N, Jain R, Appalaneni V, Anderson MA, Ben-Menachem T, Chandrasekhara V, Chathadi K, Decker GA, Early D, Evans JA, Fanelli RD, Fisher DA, Fisher LR, Foley KQ, Hwang JH, Jue TL, Ikenberry SO, Khan KM, Lightdale J, Malpas PM, Maple JT, Pasha S, Saltzman J, Dominitz JA, Cash BD. Endoscopic mucosal tissue sampling. Gastrointest Endosc. 2013 Aug;78(2):216-24. [73 references] PubMed
Guideline Status
This is the current release of the guideline.
Recommendations
Major Recommendations
Definitions for the quality of the evidence (++++, +++O, ++OO, and +OOO) and for the strength of the recommendations (“recommends” or “suggests”) are provided at the end of the “Major Recommendations” field.
Tissue Sampling Recommendations and Suggestions
| Disease | Tissue Sampling | Strength | Evidence |
|---|---|---|---|
| Esophagus | |||
| GERD | Targeted biopsies of irregular mucosa, if clinically warranted | S | ++OO |
| BE* | Surveillance of nondysplastic BE: 4-quadrant biopsies every 2 cm with large-capacity forceps for length of Barrett's mucosa | S | ++OO |
| Surveillance of BE with LGD: 4-quadrant biopsies every 1-2 cm with large-capacity forceps for length of Barrett's mucosa | R | +++O | |
| Surveillance of BE with HGD: 4-quadrant biopsies every 1 cm with large-capacity forceps for length of Barrett's mucosa | R | +++O | |
| EoE* |
2-4 biopsies from proximal esophagus
2-4 biopsies from distal esophagus Biopsies of gastric antrum and duodenum when EG suspected Biopsies should not be placed in Bouin's preservative |
S | ++OO |
| Infectious esophagitis |
Viral esophagitis
Multiple biopsies from margin and base of visualized ulcers Specimens should be sent for standard histology, IHC, and possibly viral culture and PCR |
S | ++OO |
|
Candidal esophagitis
Multiple biopsies of affected area Cytologic brushing complementary to biopsy |
S | ++OO | |
| Stomach | |||
| Helicobacter pylori ( H pylori ) infection* |
Urease test
1-2 biopsies: 5 cm proximal to the pylorus on the lesser curvature near the angularis or on the greater curve opposite the angularis |
S | ++OO |
| A negative urease test result should be confirmed with further testing for H pylori | S | ++OO | |
|
Histologic diagnosis
2 approaches: 3 biopsies: 1 from the angulus corpus-antrum junction, 1 from the greater curvature of the corpus, 1 from the greater curvature of the antrum |
S | ++OO | |
| or | |||
|
Updated Sydney Protocol
5 biopsies: 1 from the antrum 2-3 cm from the pylorus lesser curvature, 1 from the antrum 2-3 cm from the pylorus greater curvature, 1 from the corpus 8 cm from the cardia lesser curvature, 1 from the corpus 8 cm from the cardia greater curvature, 1 from the angularis |
S | ++OO | |
| If H pylori positive, perform biopsy protocol for EMAG (below) | S | ++OO | |
| EMAG* | Best data with 7-12 biopsies: 4-quadrant biopsies from antrum (2–3 cm proximal to pylorus), 2 from the angularis, 4 from the mid corpus (2 lesser curvature, 2 greater curvature), 2 from the cardia | S | ++OO |
| EMAG protocol should be sufficient for H pylori histologic diagnosis | S | ++OO | |
| Autoimmune metaplastic atrophic gastritis* | Individualize approach. Biopsies directed at ulcers, nodules, polyps, masses to rule out neoplasia | S | +OOO |
| Gastric polyps* |
Solitary polyps
Sample (biopsy or polypectomy). Further management determined by histology: Fundic gland polyp: >1 cm should undergo polypectomy† Hyperplastic polyp: >0.5 cm should undergo polypectomy‡ Adenomatous polyp: all should undergo polypectomy |
S | ++OO |
|
Multiple polyps
Largest polyp removed with polypectomy Representative sampling of smaller polyps Further management dependent on histology |
S | ++OO | |
|
For hyperplastic and adenomatous polyps
Follow EMAG protocol Biopsies of surrounding nonpolypoid mucosa |
S | ++OO | |
| Peptic ulcer disease |
Multiple biopsies from the base and edges of a gastric ulcer when malignancy is suspected or suggested by endoscopic appearance.
Cytology may be complementary |
S | ++OO |
| Perform biopsy protocol for H pylori as above | S | ++OO | |
| Small intestine | |||
| Celiac disease | 4-6 biopsies in total from duodenal bulb and distal duodenum | S | ++OO |
| Colon | |||
| Microscopic colitis |
2 approaches:
1. FS: ≥2 biopsies from the transverse colon (if possible) ≥2 biopsies from the sigmoid colon ≥2 biopsies from the descending colon |
S | ++OO |
| or | |||
|
2. Colonoscopy
≥2 biopsies from the right colon ≥2 biopsies from the transverse colon ≥2 biopsies from the descending colon ≥2 biopsies from the sigmoid colon |
S | ++OO | |
| A nondiagnostic FS should be followed by colonoscopy with biopsy, pending clinical suspicion | S | ++OO | |
| IBD* |
Initial diagnosis
Ileocolonoscopy: ≥2 biopsies from at least 5 sites, including the ileum and rectum |
S | ++OO |
|
If EGD performed for suspected IBD:
≥2 biopsies from the esophagus ≥2 biopsies from the stomach ≥2 biopsies from the duodenum |
S | ++OO | |
| Surveillance for dysplasia: all endoscopically visible lesions should undergo biopsy and/or be removed | R | ++++ | |
|
2 approaches:
1. Chromoendoscopy with pancolonic dye spraying and targeted biopsies. Also, biopsies from each colonic segment to assess inflammation. |
R | +++O | |
| or | |||
| 2. Pancolitis§: 4-quadrant biopsies every 10 cm from the cecum to the rectum, for a minimum total 33 biopsy samples | S | ++OO | |
| Nonpancolitis§: 4-quadrant biopsies every 10 cm limited to greatest extent of endoscopic or histologic involvement documented by any colonoscopy | S | ++OO | |
|
Suspected pouchitis
Multiple biopsies from the pouch and afferent limb |
S | ++OO | |
| Miscellaneous | |||
| Acute graft-versus-host disease*ǁ |
2 approaches:
1. FS ≥4 standard forceps biopsies from the rectosigmoid; ≥4 standard forceps biopsies the from left colon If FS nondiagnostic, proceed to EGD ¶ with ≥4 standard forceps biopsies each, from the gastric antrum, gastric body, and duodenum Distal esophageal biopsies may be considered |
S | ++OO |
| or | |||
|
2. Ileocolonoscopy
≥4 standard forceps biopsies from the terminal ileum ≥4 standard forceps biopsies from the right colon ≥4 standard forceps biopsies from the transverse colon ≥4 standard forceps biopsies from the left colon ≥4 standard forceps biopsies from the rectosigmoid |
S | ++OO | |
Abbreviations: S, “The Practice Committee suggests”; R, “The Practice Committee recommends”; BE, Barrett’s esophagus; EG, eosinophilic gastroenteritis; EMAG, environmental metaplastic atrophic gastritis; EoE, eosinophilic esophagitis; FS, flexible sigmoidoscopy; GERD, gastroesophageal reflux disease; HGD, high-grade dysplasia; IBD, inflammatory bowel disease; IHC, immunohistochemistry; LGD, low-grade dysplasia; PCR, polymerase chain reaction.
Recommendations in this table are as specific as published literature allows. Consensus recommendations often do not exist. Comparative effectiveness and cost-effectiveness studies were not available to guide tissue sampling suggestions. As a general principle of tissue acquisition, the Practice Committee suggests that specimen collection devices used to sample malignant tissue not be subsequently used on normal tissue to minimize the theoretical possibility of malignant contamination. For all conditions, in addition to the protocol listed, targeted biopsy samples should also be taken from any mucosal irregularities and sent in their own container for pathologic examination.
*Specimens taken from a given geographic location should be submitted to pathology in their own container.
†Recommendation is for a sporadic single fundic gland polyp that is not associated with familial adenomatous polyposis. Although sporadic fundic gland polyps have low to no malignant potential, expert opinion has been to remove fundic gland polyps larger than 1 cm. Withdrawal of a proton pump inhibitor (PPI) may be considered in patients with fundic gland polyps larger than 1cm.
‡If H pylori positive, treatment has been associated with regression of hyperplastic polyps.
§Consideration should be given to sampling every 5 cm in the distal colon.
ǁAlthough no hemorrhagic complications with biopsy were noted in the prospective literature, they have been reported in a retrospective study. Clinical judgment should be used to reduce number of biopsies if there is thought to be a significant bleeding risk.
¶Alternatively, pending clinical scenario, FS/EGD may be performed consecutively during a single endoscopic session.
Definitions:
GRADE (Grading of Recommendations Assessment, Development and Evaluation) System for Rating the Quality of Evidence for Guidelines
| Quality of Evidence | Definition | Symbol |
|---|---|---|
| High quality | Further research is very unlikely to change confidence in the estimate of effect. | ++++ |
| Moderate quality | Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate. | +++O |
| Low quality | Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. | ++OO |
| Very low quality | Any estimate of effect is very uncertain. | +OOO |
Adapted from Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.
Recommendation Strength
The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms. Weaker recommendations are indicated by phrases such as “the Practice Committee suggests,” whereas stronger recommendations are typically stated as “the Practice Committee recommends.”
Clinical Algorithm(s)
None provided
Scope
Disease/Condition(s)
Diseases of the digestive system requiring gastrointestinal endoscopy and mucosal tissue acquisition:
- Gastroesophageal reflux disease (GERD)
- Barrett’s esophagus (BE)
- Eosinophilic esophagitis (EoE)
- Infectious esophagitis (viral, candidal)
- Helicobacter pylori gastritis
- Environmental metaplastic atrophic gastritis (EMAG)
- Autoimmune atrophic metaplastic gastritis (AMAG)
- Gastric epithelial polyps
- Peptic ulcer disease
- Celiac disease
- Microscopic colitis
- Inflammatory bowel disease
- Acute graft-versus-host disease
Guideline Category
- Diagnosis
- Evaluation
- Management
Clinical Specialty
- Gastroenterology
- Internal Medicine
- Oncology
- Pathology
Intended Users
- Advanced Practice Nurses
- Physician Assistants
- Physicians
Guideline Objective(s)
To provide guidelines for the use of gastrointestinal endoscopy in mucosal tissue sampling
Target Population
Patients undergoing gastrointestinal endoscopy and tissue acquisition for diagnosis or management of diseases of the digestive system
Interventions and Practices Considered
Gastrointestinal mucosal tissue sampling, including:
- Biopsy techniques
- Standard protocols
- Specimen handling
Major Outcomes Considered
Sensitivity, specificity, accuracy, and diagnostic yield of mucosal acquisition techniques
Methodology
Methods Used to Collect/Select the Evidence
- Hand-searches of Published Literature (Primary Sources)
- Hand-searches of Published Literature (Secondary Sources)
- Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
In preparing this guideline, a search of the medical literature within the date range of January 1993 to January 2013 was performed by using PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When few or no data exist from well-designed prospective trials, emphasis is given to results of large series and reports from recognized experts.
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
- Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
GRADE (Grading of Recommendations Assessment, Development and Evaluation) System for Rating the Quality of Evidence for Guidelines
| Quality of Evidence | Definition | Symbol |
|---|---|---|
| High quality | Further research is very unlikely to change confidence in the estimate of effect. | ++++ |
| Moderate quality | Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate. | +++O |
| Low quality | Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. | ++OO |
| Very low quality | Any estimate of effect is very uncertain. | +OOO |
Adapted from Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.
Methods Used to Analyze the Evidence
- Review of Published Meta-Analyses
- Systematic Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
- Expert Consensus
Description of Methods Used to Formulate the Recommendations
Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time that the guidelines are drafted.
Rating Scheme for the Strength of the Recommendations
The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms. Weaker recommendations are indicated by phrases such as “the Practice Committee suggests,” whereas stronger recommendations are typically stated as “the Practice Committee recommends.”
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
- Internal Peer Review
Description of Method of Guideline Validation
This document is a product of the Standards of Practice Committee. This document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy (ASGE).
Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see the “Major Recommendations” field).
Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Gastrointestinal endoscopy and tissue acquisition are fundamental to the diagnosis and management of diseases of the digestive system. The proper collection of tissue specimens is required for accurate pathologic diagnosis.
Potential Harms
Not stated
Qualifying Statements
Qualifying Statements
- Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time that the guidelines are drafted. Further controlled clinical studies may be needed to clarify aspects of this guideline.
- This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient’s condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines.
Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
- Getting Better
- Living with Illness
IOM Domain
- Effectiveness
Identifying Information and Availability
Bibliographic Source(s)
- ASGE Standards of Practice Committee, Sharaf RN, Shergill AK, Odze RD, Krinsky ML, Fukami N, Jain R, Appalaneni V, Anderson MA, Ben-Menachem T, Chandrasekhara V, Chathadi K, Decker GA, Early D, Evans JA, Fanelli RD, Fisher DA, Fisher LR, Foley KQ, Hwang JH, Jue TL, Ikenberry SO, Khan KM, Lightdale J, Malpas PM, Maple JT, Pasha S, Saltzman J, Dominitz JA, Cash BD. Endoscopic mucosal tissue sampling. Gastrointest Endosc. 2013 Aug;78(2):216-24. [73 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Date Released
2013 Aug
Guideline Developer(s)
- American Society for Gastrointestinal Endoscopy - Medical Specialty Society
Source(s) of Funding
American Society for Gastrointestinal Endoscopy
Guideline Committee
Standards of Practice Committee
Composition of Group That Authored the Guideline
Committee Members : Ravi N. Sharaf, MD, MS; Amandeep K. Shergill, MD; Robert D. Odze, MD, FRCPC; Mary L. Krinsky, DO; Norio Fukami, MD; Rajeev Jain, MD; Vasundhara Appalaneni, MD; Michelle A. Anderson, MD; Tamir Ben-Menachem, MD; Vinay Chandrasekhara, MD; Krishnavel Chathadi, MD; G. Anton Decker, MD; Dana Early, MD; John A. Evans, MD; Robert D. Fanelli, MD; Deborah A. Fisher, MD; Laurel R. Fisher, MD; Kimberly Q. Foley, RN; Joo Ha Hwang, MD; Terry L. Jue, MD; Steven O. Ikenberry, MD; Khalid M. Khan, MD; Jennifer Lightdale, MD; Phyllis M. Malpas, RN CGRN; John T. Maple, DO; Shabana Pasha, MD; John Saltzman, MD; Jason A. Dominitz, MD, MHS, ( Previous Chai r); Brooks D. Cash, MD, ( Chair )
Financial Disclosures/Conflicts of Interest
The following authors disclosed financial relationships relevant to this publication: Dr. Jain is a consultant to Boston Scientific and has received research support from Barrx. Dr. D. Fisher is a consultant to Epigenomics. Dr. Hwang is a consultant to U.S. Endoscopy and a speaker for Novartis. Dr. Pasha has received research support from CapsoVision. The other authors disclosed no financial relationships relevant to this publication.
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available in Portable Document Format (PDF) from the American Society for Gastrointestinal Endoscopy (ASGE) Web site.
Print copies: Available from the American Society for Gastrointestinal Endoscopy, 1520 Kensington Road, Suite 202, Oak Brook, IL 60523
Availability of Companion Documents
None available
Patient Resources
None available
NGC Status
This NGC summary was completed by ECRI Institute on November 11, 2013.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer’s copyright restrictions.
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