Point/Counterpoint: Is ‘resect and discard’ ready for prime time?

Yes

"Resect and discard" is a policy whereby colorectal polyps smaller than a certain size have their pathology estimated during colonoscopy by an endoscopist using imaging criteria, followed by endoscopic resection of the polyps, after which the polyps are discarded and not sent to the pathology lab. In this country, target polyps are less than 5 mm. In the U.K.: less than 9 mm.

For the target polyps in the U.S. the prevalence of villous elements and high-grade dysplasia is very low, and identification of these elements in small polyps is subject to extreme interobserver variation among pathologists (Dig. Liver Dis. 2013;45:1049-55). The prevalence of cancer in polyps less than 5 mm in size is nearly nil (Aliment. Pharmacol. Ther. 2009; 31:210-7; Gastrointest. Endosc. 2012;75:1022-30). Cancer should be endoscopically recognizable in polyps of this size by criteria such as ulceration and disruption of the surface vascular pattern.

Recommendations that CT colonographers ignore polyps less than 5 mm without reporting them (Radiology 2005;236:3-9) are accepted without controversy, while paradoxically, we argue about the wisdom of not sending diminutive polyps to pathology after their pathology has been endoscopically estimated with high confidence and the polyps have then been resected.

Adenoma detection rates (ADRs) are increasing and the cost of pathology evaluation of diminutive polyps is high. Several endoscopic modalities allow accurate estimation of pathology based on image analysis (Lancet Oncol. 2013;14:1337-47). The American Society of Gastrointestinal Endoscopy (ASGE) set a threshold of 90% agreement between postpolypectomy surveillance intervals determined by endoscopists using image analysis and intervals determined by pathology evaluation of all polyps (Gastrointest. Endosc. 2011;73:419-22) to establish resect and discard as an appropriate paradigm for clinical practice. Narrow-band imaging allows endoscopists to achieve the threshold set by ASGE (Gut 2013;62:1704-13) and only a few studies, done primarily by community-based endoscopists with limited training, have failed to meet the ASGE target (Gastroenterology 2013;144:5-8; Gut 2014;63:458-65). Cost analyses show that "resect and discard" could save more than $1 billion per year in the U.S. alone (Endoscopy 2011;43:683-91).

ASGE recommends that polyps be discarded only when pathology is interpreted with high confidence. When a diagnosis is already recognized in clinical practice with high probability, ordering a confirmatory test is considered money wasted. Money is considered well spent when the diagnosis is uncertain, and pathologic interpretation of polyps less than 5 mm in size is a good example.

"Resect and discard" will require endorsement by GI societies, re-education of patients, a credentialing process (given the recent low performance by community endoscopists), creation of training tools, and new documentation schemes based on photography for quality measures such as ADR. Documentation of ADR and medical-legal protection for endoscopists will require storage of high-quality images that record the basis for an endoscopist’s decision. Finally, institutional policies that require submission of resected tissue for pathology will need revision.

Success will depend on aligning the policy with the financial incentives of endoscopists with the introduction of a CPT code for confocal laser microscopy in the United States. Bundled payment, which includes the cost of pathology (Gastroenterology 2014;146:849-53), would create strong motivation for "resect and discard."

Dr. Douglas K. Rex, AGAF, is Distinguished Professor of Medicine, Indiana University School of Medicine, Indianapolis; Chancellor’s Professor, Indiana University–Purdue University Indianapolis; and director of endoscopy, Indiana University Hospital.

No

First, standards will be needed for a new diagnostic test. Point of care testing (POCT) is defined as medical diagnostic testing performed outside the clinical laboratory in close proximity to where the patient is receiving care. POCT is typically performed by nonlaboratory personnel and the results are used for clinical decision making. This is therefore a POCT and subject to all of the requirements of POC tests. Accreditation bodies hold departments of pathology accountable for their oversight and quality by Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP), while input comes from the Food and Drug Administration, Centers for Medicare & Medicaid Services, and the Centers for Disease Control and Prevention.

Second, accreditation will be required to guarantee the quality of all POC tests as well as re-accreditation. Will accreditation be for each endoscopist who will need to demonstrate diagnostic competence, or for each endoscopy unit? How will this be accomplished? At what cost? How will maintenance of competence work?

If one argues there will be no need for accreditation, there will almost certainly be opposition from CLIA, CAP, and numerous other pathologist groups. The obvious argument is that endoscopic assessment does not match up to pathology so it is a substandard test.

The notion that it can be justified as it gives an immediate diagnosis needs no further comment. There may also be opposition from gastroenterology/endoscopy groups who doubt that those who are more academic or better equipped can do this with 95%+ success or better than they or their own group can.

Are we assuming that the lower diagnostic standards of endoscopy are acceptable as they will not impact significantly on patient management? Why do we need to know precisely the pathology of polyps? Important differential diagnoses that really change follow-up include detecting the third adenoma, distinguishing adenomas from serrated polyps, hyperplastic polyps from sessile serrated polyps/adenomas (SSP/As), which can be difficult histologically, and especially dysplastic SSP/As from nondysplastic ones. Endoscopists need to demonstrate their competence at these skills for accreditation when this may not currently be possible, and identifying adenomas and SSP/As with early invasive cancer, which may not be resectable. Although uncommon, these are sometimes less than 5 mm.

Third, the issue is that it is one thing to say that a specific endoscopist can be accurate in studies based on less than 500 polyps, but when this is translated to an entire unit – after 10,000+ polyps, or a state, or the entire country. When 25 missed diagnoses become 1000, or 100,000. What gets missed that matters? Other tumors presenting as lower bowel polyps include carcinoids (low grade neuroendocrine tumors), metastatic carcinoma, metastatic melanomas, and lymphomas. While all of these are indicative of widespread disease, many are treatable.

There are intangibles at work in my argument as well. You never really know what you are dealing with when you discard the polyp. Even if accredited, are you really comfortable doing this? Would you be happy having your own polyps thrown out?

So where does this leave us? There are many issues, some of which are obvious but others less so, and there may even be some that have not yet to come to light. This summarizes the state of the art regarding the field of surveillance endoscopy and pathology. There are far too many challenges and hurdles to seriously consider implementing this policy now. It is not ready for prime time.

Dr. Robert H. Riddell is professor of laboratory medicine and pathobiology, University of Toronto, and Mount Sinai Hospital, Toronto.

Both Dr. Rex and Dr. Riddell made their comments during the ASGE and AGA joint Presidential Plenary at the annual Digestive Disease Week.

Do you think 'resect and discard' is ready for prime time? Take our Quick Poll on the GI & Hepatology News homepage.

Yes

"Resect and discard" is a policy whereby colorectal polyps smaller than a certain size have their pathology estimated during colonoscopy by an endoscopist using imaging criteria, followed by endoscopic resection of the polyps, after which the polyps are discarded and not sent to the pathology lab. In this country, target polyps are less than 5 mm. In the U.K.: less than 9 mm.

For the target polyps in the U.S. the prevalence of villous elements and high-grade dysplasia is very low, and identification of these elements in small polyps is subject to extreme interobserver variation among pathologists (Dig. Liver Dis. 2013;45:1049-55). The prevalence of cancer in polyps less than 5 mm in size is nearly nil (Aliment. Pharmacol. Ther. 2009; 31:210-7; Gastrointest. Endosc. 2012;75:1022-30). Cancer should be endoscopically recognizable in polyps of this size by criteria such as ulceration and disruption of the surface vascular pattern.

Recommendations that CT colonographers ignore polyps less than 5 mm without reporting them (Radiology 2005;236:3-9) are accepted without controversy, while paradoxically, we argue about the wisdom of not sending diminutive polyps to pathology after their pathology has been endoscopically estimated with high confidence and the polyps have then been resected.

Adenoma detection rates (ADRs) are increasing and the cost of pathology evaluation of diminutive polyps is high. Several endoscopic modalities allow accurate estimation of pathology based on image analysis (Lancet Oncol. 2013;14:1337-47). The American Society of Gastrointestinal Endoscopy (ASGE) set a threshold of 90% agreement between postpolypectomy surveillance intervals determined by endoscopists using image analysis and intervals determined by pathology evaluation of all polyps (Gastrointest. Endosc. 2011;73:419-22) to establish resect and discard as an appropriate paradigm for clinical practice. Narrow-band imaging allows endoscopists to achieve the threshold set by ASGE (Gut 2013;62:1704-13) and only a few studies, done primarily by community-based endoscopists with limited training, have failed to meet the ASGE target (Gastroenterology 2013;144:5-8; Gut 2014;63:458-65). Cost analyses show that "resect and discard" could save more than $1 billion per year in the U.S. alone (Endoscopy 2011;43:683-91).

ASGE recommends that polyps be discarded only when pathology is interpreted with high confidence. When a diagnosis is already recognized in clinical practice with high probability, ordering a confirmatory test is considered money wasted. Money is considered well spent when the diagnosis is uncertain, and pathologic interpretation of polyps less than 5 mm in size is a good example.

"Resect and discard" will require endorsement by GI societies, re-education of patients, a credentialing process (given the recent low performance by community endoscopists), creation of training tools, and new documentation schemes based on photography for quality measures such as ADR. Documentation of ADR and medical-legal protection for endoscopists will require storage of high-quality images that record the basis for an endoscopist’s decision. Finally, institutional policies that require submission of resected tissue for pathology will need revision.

Success will depend on aligning the policy with the financial incentives of endoscopists with the introduction of a CPT code for confocal laser microscopy in the United States. Bundled payment, which includes the cost of pathology (Gastroenterology 2014;146:849-53), would create strong motivation for "resect and discard."

Dr. Douglas K. Rex, AGAF, is Distinguished Professor of Medicine, Indiana University School of Medicine, Indianapolis; Chancellor’s Professor, Indiana University–Purdue University Indianapolis; and director of endoscopy, Indiana University Hospital.

No

First, standards will be needed for a new diagnostic test. Point of care testing (POCT) is defined as medical diagnostic testing performed outside the clinical laboratory in close proximity to where the patient is receiving care. POCT is typically performed by nonlaboratory personnel and the results are used for clinical decision making. This is therefore a POCT and subject to all of the requirements of POC tests. Accreditation bodies hold departments of pathology accountable for their oversight and quality by Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP), while input comes from the Food and Drug Administration, Centers for Medicare & Medicaid Services, and the Centers for Disease Control and Prevention.

Second, accreditation will be required to guarantee the quality of all POC tests as well as re-accreditation. Will accreditation be for each endoscopist who will need to demonstrate diagnostic competence, or for each endoscopy unit? How will this be accomplished? At what cost? How will maintenance of competence work?

If one argues there will be no need for accreditation, there will almost certainly be opposition from CLIA, CAP, and numerous other pathologist groups. The obvious argument is that endoscopic assessment does not match up to pathology so it is a substandard test.

The notion that it can be justified as it gives an immediate diagnosis needs no further comment. There may also be opposition from gastroenterology/endoscopy groups who doubt that those who are more academic or better equipped can do this with 95%+ success or better than they or their own group can.

Are we assuming that the lower diagnostic standards of endoscopy are acceptable as they will not impact significantly on patient management? Why do we need to know precisely the pathology of polyps? Important differential diagnoses that really change follow-up include detecting the third adenoma, distinguishing adenomas from serrated polyps, hyperplastic polyps from sessile serrated polyps/adenomas (SSP/As), which can be difficult histologically, and especially dysplastic SSP/As from nondysplastic ones. Endoscopists need to demonstrate their competence at these skills for accreditation when this may not currently be possible, and identifying adenomas and SSP/As with early invasive cancer, which may not be resectable. Although uncommon, these are sometimes less than 5 mm.

Third, the issue is that it is one thing to say that a specific endoscopist can be accurate in studies based on less than 500 polyps, but when this is translated to an entire unit – after 10,000+ polyps, or a state, or the entire country. When 25 missed diagnoses become 1000, or 100,000. What gets missed that matters? Other tumors presenting as lower bowel polyps include carcinoids (low grade neuroendocrine tumors), metastatic carcinoma, metastatic melanomas, and lymphomas. While all of these are indicative of widespread disease, many are treatable.

There are intangibles at work in my argument as well. You never really know what you are dealing with when you discard the polyp. Even if accredited, are you really comfortable doing this? Would you be happy having your own polyps thrown out?

So where does this leave us? There are many issues, some of which are obvious but others less so, and there may even be some that have not yet to come to light. This summarizes the state of the art regarding the field of surveillance endoscopy and pathology. There are far too many challenges and hurdles to seriously consider implementing this policy now. It is not ready for prime time.

Dr. Robert H. Riddell is professor of laboratory medicine and pathobiology, University of Toronto, and Mount Sinai Hospital, Toronto.

Both Dr. Rex and Dr. Riddell made their comments during the ASGE and AGA joint Presidential Plenary at the annual Digestive Disease Week.

Do you think 'resect and discard' is ready for prime time? Take our Quick Poll on the GI & Hepatology News homepage.

Yes

"Resect and discard" is a policy whereby colorectal polyps smaller than a certain size have their pathology estimated during colonoscopy by an endoscopist using imaging criteria, followed by endoscopic resection of the polyps, after which the polyps are discarded and not sent to the pathology lab. In this country, target polyps are less than 5 mm. In the U.K.: less than 9 mm.

For the target polyps in the U.S. the prevalence of villous elements and high-grade dysplasia is very low, and identification of these elements in small polyps is subject to extreme interobserver variation among pathologists (Dig. Liver Dis. 2013;45:1049-55). The prevalence of cancer in polyps less than 5 mm in size is nearly nil (Aliment. Pharmacol. Ther. 2009; 31:210-7; Gastrointest. Endosc. 2012;75:1022-30). Cancer should be endoscopically recognizable in polyps of this size by criteria such as ulceration and disruption of the surface vascular pattern.

Recommendations that CT colonographers ignore polyps less than 5 mm without reporting them (Radiology 2005;236:3-9) are accepted without controversy, while paradoxically, we argue about the wisdom of not sending diminutive polyps to pathology after their pathology has been endoscopically estimated with high confidence and the polyps have then been resected.

Adenoma detection rates (ADRs) are increasing and the cost of pathology evaluation of diminutive polyps is high. Several endoscopic modalities allow accurate estimation of pathology based on image analysis (Lancet Oncol. 2013;14:1337-47). The American Society of Gastrointestinal Endoscopy (ASGE) set a threshold of 90% agreement between postpolypectomy surveillance intervals determined by endoscopists using image analysis and intervals determined by pathology evaluation of all polyps (Gastrointest. Endosc. 2011;73:419-22) to establish resect and discard as an appropriate paradigm for clinical practice. Narrow-band imaging allows endoscopists to achieve the threshold set by ASGE (Gut 2013;62:1704-13) and only a few studies, done primarily by community-based endoscopists with limited training, have failed to meet the ASGE target (Gastroenterology 2013;144:5-8; Gut 2014;63:458-65). Cost analyses show that "resect and discard" could save more than $1 billion per year in the U.S. alone (Endoscopy 2011;43:683-91).

ASGE recommends that polyps be discarded only when pathology is interpreted with high confidence. When a diagnosis is already recognized in clinical practice with high probability, ordering a confirmatory test is considered money wasted. Money is considered well spent when the diagnosis is uncertain, and pathologic interpretation of polyps less than 5 mm in size is a good example.

"Resect and discard" will require endorsement by GI societies, re-education of patients, a credentialing process (given the recent low performance by community endoscopists), creation of training tools, and new documentation schemes based on photography for quality measures such as ADR. Documentation of ADR and medical-legal protection for endoscopists will require storage of high-quality images that record the basis for an endoscopist’s decision. Finally, institutional policies that require submission of resected tissue for pathology will need revision.

Success will depend on aligning the policy with the financial incentives of endoscopists with the introduction of a CPT code for confocal laser microscopy in the United States. Bundled payment, which includes the cost of pathology (Gastroenterology 2014;146:849-53), would create strong motivation for "resect and discard."

Dr. Douglas K. Rex, AGAF, is Distinguished Professor of Medicine, Indiana University School of Medicine, Indianapolis; Chancellor’s Professor, Indiana University–Purdue University Indianapolis; and director of endoscopy, Indiana University Hospital.

No

First, standards will be needed for a new diagnostic test. Point of care testing (POCT) is defined as medical diagnostic testing performed outside the clinical laboratory in close proximity to where the patient is receiving care. POCT is typically performed by nonlaboratory personnel and the results are used for clinical decision making. This is therefore a POCT and subject to all of the requirements of POC tests. Accreditation bodies hold departments of pathology accountable for their oversight and quality by Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP), while input comes from the Food and Drug Administration, Centers for Medicare & Medicaid Services, and the Centers for Disease Control and Prevention.

Second, accreditation will be required to guarantee the quality of all POC tests as well as re-accreditation. Will accreditation be for each endoscopist who will need to demonstrate diagnostic competence, or for each endoscopy unit? How will this be accomplished? At what cost? How will maintenance of competence work?

If one argues there will be no need for accreditation, there will almost certainly be opposition from CLIA, CAP, and numerous other pathologist groups. The obvious argument is that endoscopic assessment does not match up to pathology so it is a substandard test.

The notion that it can be justified as it gives an immediate diagnosis needs no further comment. There may also be opposition from gastroenterology/endoscopy groups who doubt that those who are more academic or better equipped can do this with 95%+ success or better than they or their own group can.

Are we assuming that the lower diagnostic standards of endoscopy are acceptable as they will not impact significantly on patient management? Why do we need to know precisely the pathology of polyps? Important differential diagnoses that really change follow-up include detecting the third adenoma, distinguishing adenomas from serrated polyps, hyperplastic polyps from sessile serrated polyps/adenomas (SSP/As), which can be difficult histologically, and especially dysplastic SSP/As from nondysplastic ones. Endoscopists need to demonstrate their competence at these skills for accreditation when this may not currently be possible, and identifying adenomas and SSP/As with early invasive cancer, which may not be resectable. Although uncommon, these are sometimes less than 5 mm.

Third, the issue is that it is one thing to say that a specific endoscopist can be accurate in studies based on less than 500 polyps, but when this is translated to an entire unit – after 10,000+ polyps, or a state, or the entire country. When 25 missed diagnoses become 1000, or 100,000. What gets missed that matters? Other tumors presenting as lower bowel polyps include carcinoids (low grade neuroendocrine tumors), metastatic carcinoma, metastatic melanomas, and lymphomas. While all of these are indicative of widespread disease, many are treatable.

There are intangibles at work in my argument as well. You never really know what you are dealing with when you discard the polyp. Even if accredited, are you really comfortable doing this? Would you be happy having your own polyps thrown out?

So where does this leave us? There are many issues, some of which are obvious but others less so, and there may even be some that have not yet to come to light. This summarizes the state of the art regarding the field of surveillance endoscopy and pathology. There are far too many challenges and hurdles to seriously consider implementing this policy now. It is not ready for prime time.

Dr. Robert H. Riddell is professor of laboratory medicine and pathobiology, University of Toronto, and Mount Sinai Hospital, Toronto.

Both Dr. Rex and Dr. Riddell made their comments during the ASGE and AGA joint Presidential Plenary at the annual Digestive Disease Week.

Do you think 'resect and discard' is ready for prime time? Take our Quick Poll on the GI & Hepatology News homepage.