Diagnostic performance of a new endoscopic scraper for malignant biliary strictures: a multicenter prospective study
Background and Aims The efficacy of ERCP for histologic diagnosis of malignant biliary strictures is disappointingly low. The aim of this study was to investigate the diagnostic performance of a newly developed endoscopic device with scraping loops in combination with conventional biopsy forceps. Me...
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| creator | Sakuma, Yojiro, MD Kodama, Yuzo, MD, PhD Sogabe, Yuko, MD Nakai, Yoshitaka, MD Yamashita, Yukitaka, MD, PhD Mikami, Sakae, MD, PhD Kajimura, Kozo, MD, PhD Ikeda, Kazuki, MD, PhD Tamaki, Hiroyuki, MD, PhD Iwamoto, Satoru, MD, PhD Matsuda, Fumihiro, MD Fujita, Koichi, MD Uza, Norimitsu, MD, PhD Kawamura, Takashi, MD, PhD Uemoto, Shinji, MD, PhD Seno, Hiroshi, MD, PhD Chiba, Tsutomu, MD, PhD Yazumi, Shujiro, MD, PhD |
| description | Background and Aims The efficacy of ERCP for histologic diagnosis of malignant biliary strictures is disappointingly low. The aim of this study was to investigate the diagnostic performance of a newly developed endoscopic device with scraping loops in combination with conventional biopsy forceps. Methods We performed a multicenter single-arm prospective study. Between February 2013 and December 2014, 123 patients with suspected malignant biliary strictures were enrolled in the study. The new device and conventional biopsy forceps were applied for histologic diagnosis by ERCP. The primary outcome was to evaluate cancer detectability by biopsy forceps, the new device, and their combined use. Results Of the 123 patients, 119 were diagnosed with a malignant stricture. Sufficient samples were collected in 83.7% (103/123), 93.5% (115/123), and 95.9% (118/123) of patients using biopsy forceps, the new device, and their combination, respectively. Cancer detectability of forceps biopsy, the new device, and their combination were 51.3% (61/119), 64.7% (77/119), and 74.8% (89/119), respectively. The new device had a significantly higher sample yield and cancer detectability than biopsy forceps ( P < .01 and P = .018, respectively, McNemar test). Complementary use of the new device with biopsy forceps demonstrated a significantly additive effect in both sample yield and cancer detection ( P < .01 each, McNemar test). The new device detected 48.3% (28/58) of cancers that were not diagnosed as malignant by biopsy forceps. Conclusions The new endoscopic scraper demonstrated a large sample yield and high cancer detectability. It could be a first-line tissue-sampling device for biliary strictures. (University Hospital Medical Information Network Clinical Trial Registry [UMIN-CTR] ( http://www.umin.ac.jp/ctr/index.htm ) registration number: UMIN000009895.) |
| doi_str_mv | 10.1016/j.gie.2016.07.060 |
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The aim of this study was to investigate the diagnostic performance of a newly developed endoscopic device with scraping loops in combination with conventional biopsy forceps. Methods We performed a multicenter single-arm prospective study. Between February 2013 and December 2014, 123 patients with suspected malignant biliary strictures were enrolled in the study. The new device and conventional biopsy forceps were applied for histologic diagnosis by ERCP. The primary outcome was to evaluate cancer detectability by biopsy forceps, the new device, and their combined use. Results Of the 123 patients, 119 were diagnosed with a malignant stricture. Sufficient samples were collected in 83.7% (103/123), 93.5% (115/123), and 95.9% (118/123) of patients using biopsy forceps, the new device, and their combination, respectively. Cancer detectability of forceps biopsy, the new device, and their combination were 51.3% (61/119), 64.7% (77/119), and 74.8% (89/119), respectively. The new device had a significantly higher sample yield and cancer detectability than biopsy forceps ( P < .01 and P = .018, respectively, McNemar test). Complementary use of the new device with biopsy forceps demonstrated a significantly additive effect in both sample yield and cancer detection ( P < .01 each, McNemar test). The new device detected 48.3% (28/58) of cancers that were not diagnosed as malignant by biopsy forceps. Conclusions The new endoscopic scraper demonstrated a large sample yield and high cancer detectability. It could be a first-line tissue-sampling device for biliary strictures. (University Hospital Medical Information Network Clinical Trial Registry [UMIN-CTR] ( http://www.umin.ac.jp/ctr/index.htm ) registration number: UMIN000009895.)</description><identifier>ISSN: 0016-5107</identifier><identifier>EISSN: 1097-6779</identifier><identifier>DOI: 10.1016/j.gie.2016.07.060</identifier><identifier>PMID: 27497604</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Bile Duct Diseases - diagnosis ; Bile Duct Diseases - etiology ; Bile Duct Neoplasms - complications ; Bile Duct Neoplasms - diagnosis ; Bile Duct Neoplasms - pathology ; Bile Ducts - pathology ; Biopsy - instrumentation ; Cholangiocarcinoma - complications ; Cholangiocarcinoma - diagnosis ; Cholangiocarcinoma - pathology ; Cholangiopancreatography, Endoscopic Retrograde - instrumentation ; Constriction, Pathologic ; Female ; Gallbladder Neoplasms - complications ; Gallbladder Neoplasms - diagnosis ; Gallbladder Neoplasms - pathology ; Gastroenterology and Hepatology ; Humans ; Male ; Middle Aged ; Pancreatic Neoplasms - complications ; Pancreatic Neoplasms - diagnosis ; Pancreatic Neoplasms - pathology ; Prospective Studies</subject><ispartof>Gastrointestinal endoscopy, 2017-02, Vol.85 (2), p.371-379</ispartof><rights>American Society for Gastrointestinal Endoscopy</rights><rights>2017 American Society for Gastrointestinal Endoscopy</rights><rights>Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-c7e4194cd4e3ade80bcef1cdee0b69d9ac5a8986955c89413cc8fe34497a1c13</citedby><cites>FETCH-LOGICAL-c474t-c7e4194cd4e3ade80bcef1cdee0b69d9ac5a8986955c89413cc8fe34497a1c13</cites><orcidid>0000-0002-0623-3871</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S001651071630445X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27497604$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sakuma, Yojiro, MD</creatorcontrib><creatorcontrib>Kodama, Yuzo, MD, PhD</creatorcontrib><creatorcontrib>Sogabe, Yuko, MD</creatorcontrib><creatorcontrib>Nakai, Yoshitaka, MD</creatorcontrib><creatorcontrib>Yamashita, Yukitaka, MD, PhD</creatorcontrib><creatorcontrib>Mikami, Sakae, MD, PhD</creatorcontrib><creatorcontrib>Kajimura, Kozo, MD, PhD</creatorcontrib><creatorcontrib>Ikeda, Kazuki, MD, PhD</creatorcontrib><creatorcontrib>Tamaki, Hiroyuki, MD, PhD</creatorcontrib><creatorcontrib>Iwamoto, Satoru, MD, PhD</creatorcontrib><creatorcontrib>Matsuda, Fumihiro, MD</creatorcontrib><creatorcontrib>Fujita, Koichi, MD</creatorcontrib><creatorcontrib>Uza, Norimitsu, MD, PhD</creatorcontrib><creatorcontrib>Kawamura, Takashi, MD, PhD</creatorcontrib><creatorcontrib>Uemoto, Shinji, MD, PhD</creatorcontrib><creatorcontrib>Seno, Hiroshi, MD, PhD</creatorcontrib><creatorcontrib>Chiba, Tsutomu, MD, PhD</creatorcontrib><creatorcontrib>Yazumi, Shujiro, MD, PhD</creatorcontrib><creatorcontrib>Kyoto Pancreatobiliary Study Group</creatorcontrib><title>Diagnostic performance of a new endoscopic scraper for malignant biliary strictures: a multicenter prospective study</title><title>Gastrointestinal endoscopy</title><addtitle>Gastrointest Endosc</addtitle><description>Background and Aims The efficacy of ERCP for histologic diagnosis of malignant biliary strictures is disappointingly low. The aim of this study was to investigate the diagnostic performance of a newly developed endoscopic device with scraping loops in combination with conventional biopsy forceps. Methods We performed a multicenter single-arm prospective study. Between February 2013 and December 2014, 123 patients with suspected malignant biliary strictures were enrolled in the study. The new device and conventional biopsy forceps were applied for histologic diagnosis by ERCP. The primary outcome was to evaluate cancer detectability by biopsy forceps, the new device, and their combined use. Results Of the 123 patients, 119 were diagnosed with a malignant stricture. Sufficient samples were collected in 83.7% (103/123), 93.5% (115/123), and 95.9% (118/123) of patients using biopsy forceps, the new device, and their combination, respectively. Cancer detectability of forceps biopsy, the new device, and their combination were 51.3% (61/119), 64.7% (77/119), and 74.8% (89/119), respectively. The new device had a significantly higher sample yield and cancer detectability than biopsy forceps ( P < .01 and P = .018, respectively, McNemar test). Complementary use of the new device with biopsy forceps demonstrated a significantly additive effect in both sample yield and cancer detection ( P < .01 each, McNemar test). The new device detected 48.3% (28/58) of cancers that were not diagnosed as malignant by biopsy forceps. Conclusions The new endoscopic scraper demonstrated a large sample yield and high cancer detectability. It could be a first-line tissue-sampling device for biliary strictures. (University Hospital Medical Information Network Clinical Trial Registry [UMIN-CTR] ( http://www.umin.ac.jp/ctr/index.htm ) registration number: UMIN000009895.)</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Bile Duct Diseases - diagnosis</subject><subject>Bile Duct Diseases - etiology</subject><subject>Bile Duct Neoplasms - complications</subject><subject>Bile Duct Neoplasms - diagnosis</subject><subject>Bile Duct Neoplasms - pathology</subject><subject>Bile Ducts - pathology</subject><subject>Biopsy - instrumentation</subject><subject>Cholangiocarcinoma - complications</subject><subject>Cholangiocarcinoma - diagnosis</subject><subject>Cholangiocarcinoma - pathology</subject><subject>Cholangiopancreatography, Endoscopic Retrograde - instrumentation</subject><subject>Constriction, Pathologic</subject><subject>Female</subject><subject>Gallbladder Neoplasms - complications</subject><subject>Gallbladder Neoplasms - diagnosis</subject><subject>Gallbladder Neoplasms - pathology</subject><subject>Gastroenterology and Hepatology</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pancreatic Neoplasms - complications</subject><subject>Pancreatic Neoplasms - diagnosis</subject><subject>Pancreatic Neoplasms - pathology</subject><subject>Prospective Studies</subject><issn>0016-5107</issn><issn>1097-6779</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcFu1DAQhi0EotvCA3BBOXJJsDdOHIOEhAoFpEoc6IGb5R1PVl4SO9hO0b49s9rCgQMnW5rvH818w9gLwRvBRf_60Ow9Nlv6Nlw1vOeP2EZwrepeKf2YbThV6k5wdcEucz5wzodtK56yi62SWvVcblj54O0-xFw8VAumMabZBsAqjpWtAv6qMLiYIS5Uz5AsMRVB1Wwnvw82lGrnJ2_TscoleShrwvyGovM6UUsMhfglxbwgFH-PRK3u-Iw9Ge2U8fnDe8Xubj7eXX-ub79--nL9_rYGqWSpQaEUWoKT2FqHA98BjgIcIt_12mkLnR300Ouug0FL0QIMI7aSdrMCRHvFXp3b0gA_V8zFzD4DTpMNGNdsxNBpJUQ_KELFGQWaNScczZL8TGsZwc3JtTkYcm1Org1XhlxT5uVD-3U3o_ub-COXgLdnAGnHe4_JZPBIdp1PpMO46P_b_t0_aZh88GCnH3jEfIhrCiTPCJO3hptvp2Ofbi36lkvZfW9_Ay5Bp2Q</recordid><startdate>20170201</startdate><enddate>20170201</enddate><creator>Sakuma, Yojiro, MD</creator><creator>Kodama, Yuzo, MD, PhD</creator><creator>Sogabe, Yuko, MD</creator><creator>Nakai, Yoshitaka, MD</creator><creator>Yamashita, Yukitaka, MD, PhD</creator><creator>Mikami, Sakae, MD, PhD</creator><creator>Kajimura, Kozo, MD, PhD</creator><creator>Ikeda, Kazuki, MD, PhD</creator><creator>Tamaki, Hiroyuki, MD, PhD</creator><creator>Iwamoto, Satoru, MD, PhD</creator><creator>Matsuda, Fumihiro, MD</creator><creator>Fujita, Koichi, MD</creator><creator>Uza, Norimitsu, MD, PhD</creator><creator>Kawamura, Takashi, MD, PhD</creator><creator>Uemoto, Shinji, MD, PhD</creator><creator>Seno, Hiroshi, MD, PhD</creator><creator>Chiba, Tsutomu, MD, PhD</creator><creator>Yazumi, Shujiro, MD, PhD</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0623-3871</orcidid></search><sort><creationdate>20170201</creationdate><title>Diagnostic performance of a new endoscopic scraper for malignant biliary strictures: a multicenter prospective study</title><author>Sakuma, Yojiro, MD ; Kodama, Yuzo, MD, PhD ; Sogabe, Yuko, MD ; Nakai, Yoshitaka, MD ; Yamashita, Yukitaka, MD, PhD ; Mikami, Sakae, MD, PhD ; Kajimura, Kozo, MD, PhD ; Ikeda, Kazuki, MD, PhD ; Tamaki, Hiroyuki, MD, PhD ; Iwamoto, Satoru, MD, PhD ; Matsuda, Fumihiro, MD ; Fujita, Koichi, MD ; Uza, Norimitsu, MD, PhD ; Kawamura, Takashi, MD, PhD ; Uemoto, Shinji, MD, PhD ; Seno, Hiroshi, MD, PhD ; Chiba, Tsutomu, MD, PhD ; Yazumi, Shujiro, MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-c7e4194cd4e3ade80bcef1cdee0b69d9ac5a8986955c89413cc8fe34497a1c13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Bile Duct Diseases - diagnosis</topic><topic>Bile Duct Diseases - etiology</topic><topic>Bile Duct Neoplasms - complications</topic><topic>Bile Duct Neoplasms - diagnosis</topic><topic>Bile Duct Neoplasms - pathology</topic><topic>Bile Ducts - pathology</topic><topic>Biopsy - instrumentation</topic><topic>Cholangiocarcinoma - complications</topic><topic>Cholangiocarcinoma - diagnosis</topic><topic>Cholangiocarcinoma - pathology</topic><topic>Cholangiopancreatography, Endoscopic Retrograde - instrumentation</topic><topic>Constriction, Pathologic</topic><topic>Female</topic><topic>Gallbladder Neoplasms - complications</topic><topic>Gallbladder Neoplasms - diagnosis</topic><topic>Gallbladder Neoplasms - pathology</topic><topic>Gastroenterology and Hepatology</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pancreatic Neoplasms - complications</topic><topic>Pancreatic Neoplasms - diagnosis</topic><topic>Pancreatic Neoplasms - pathology</topic><topic>Prospective Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sakuma, Yojiro, MD</creatorcontrib><creatorcontrib>Kodama, Yuzo, MD, PhD</creatorcontrib><creatorcontrib>Sogabe, Yuko, MD</creatorcontrib><creatorcontrib>Nakai, Yoshitaka, MD</creatorcontrib><creatorcontrib>Yamashita, Yukitaka, MD, PhD</creatorcontrib><creatorcontrib>Mikami, Sakae, MD, PhD</creatorcontrib><creatorcontrib>Kajimura, Kozo, MD, PhD</creatorcontrib><creatorcontrib>Ikeda, Kazuki, MD, PhD</creatorcontrib><creatorcontrib>Tamaki, Hiroyuki, MD, PhD</creatorcontrib><creatorcontrib>Iwamoto, Satoru, MD, PhD</creatorcontrib><creatorcontrib>Matsuda, Fumihiro, MD</creatorcontrib><creatorcontrib>Fujita, Koichi, MD</creatorcontrib><creatorcontrib>Uza, Norimitsu, MD, PhD</creatorcontrib><creatorcontrib>Kawamura, Takashi, MD, PhD</creatorcontrib><creatorcontrib>Uemoto, Shinji, MD, PhD</creatorcontrib><creatorcontrib>Seno, Hiroshi, MD, PhD</creatorcontrib><creatorcontrib>Chiba, Tsutomu, MD, PhD</creatorcontrib><creatorcontrib>Yazumi, Shujiro, MD, PhD</creatorcontrib><creatorcontrib>Kyoto Pancreatobiliary Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gastrointestinal endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sakuma, Yojiro, MD</au><au>Kodama, Yuzo, MD, PhD</au><au>Sogabe, Yuko, MD</au><au>Nakai, Yoshitaka, MD</au><au>Yamashita, Yukitaka, MD, PhD</au><au>Mikami, Sakae, MD, PhD</au><au>Kajimura, Kozo, MD, PhD</au><au>Ikeda, Kazuki, MD, PhD</au><au>Tamaki, Hiroyuki, MD, PhD</au><au>Iwamoto, Satoru, MD, PhD</au><au>Matsuda, Fumihiro, MD</au><au>Fujita, Koichi, MD</au><au>Uza, Norimitsu, MD, PhD</au><au>Kawamura, Takashi, MD, PhD</au><au>Uemoto, Shinji, MD, PhD</au><au>Seno, Hiroshi, MD, PhD</au><au>Chiba, Tsutomu, MD, PhD</au><au>Yazumi, Shujiro, MD, PhD</au><aucorp>Kyoto Pancreatobiliary Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Diagnostic performance of a new endoscopic scraper for malignant biliary strictures: a multicenter prospective study</atitle><jtitle>Gastrointestinal endoscopy</jtitle><addtitle>Gastrointest Endosc</addtitle><date>2017-02-01</date><risdate>2017</risdate><volume>85</volume><issue>2</issue><spage>371</spage><epage>379</epage><pages>371-379</pages><issn>0016-5107</issn><eissn>1097-6779</eissn><abstract>Background and Aims The efficacy of ERCP for histologic diagnosis of malignant biliary strictures is disappointingly low. The aim of this study was to investigate the diagnostic performance of a newly developed endoscopic device with scraping loops in combination with conventional biopsy forceps. Methods We performed a multicenter single-arm prospective study. Between February 2013 and December 2014, 123 patients with suspected malignant biliary strictures were enrolled in the study. The new device and conventional biopsy forceps were applied for histologic diagnosis by ERCP. The primary outcome was to evaluate cancer detectability by biopsy forceps, the new device, and their combined use. Results Of the 123 patients, 119 were diagnosed with a malignant stricture. Sufficient samples were collected in 83.7% (103/123), 93.5% (115/123), and 95.9% (118/123) of patients using biopsy forceps, the new device, and their combination, respectively. Cancer detectability of forceps biopsy, the new device, and their combination were 51.3% (61/119), 64.7% (77/119), and 74.8% (89/119), respectively. The new device had a significantly higher sample yield and cancer detectability than biopsy forceps ( P < .01 and P = .018, respectively, McNemar test). Complementary use of the new device with biopsy forceps demonstrated a significantly additive effect in both sample yield and cancer detection ( P < .01 each, McNemar test). The new device detected 48.3% (28/58) of cancers that were not diagnosed as malignant by biopsy forceps. Conclusions The new endoscopic scraper demonstrated a large sample yield and high cancer detectability. It could be a first-line tissue-sampling device for biliary strictures. (University Hospital Medical Information Network Clinical Trial Registry [UMIN-CTR] ( http://www.umin.ac.jp/ctr/index.htm ) registration number: UMIN000009895.)</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>27497604</pmid><doi>10.1016/j.gie.2016.07.060</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-0623-3871</orcidid></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Bile Duct Diseases - diagnosis Bile Duct Diseases - etiology Bile Duct Neoplasms - complications Bile Duct Neoplasms - diagnosis Bile Duct Neoplasms - pathology Bile Ducts - pathology Biopsy - instrumentation Cholangiocarcinoma - complications Cholangiocarcinoma - diagnosis Cholangiocarcinoma - pathology Cholangiopancreatography, Endoscopic Retrograde - instrumentation Constriction, Pathologic Female Gallbladder Neoplasms - complications Gallbladder Neoplasms - diagnosis Gallbladder Neoplasms - pathology Gastroenterology and Hepatology Humans Male Middle Aged Pancreatic Neoplasms - complications Pancreatic Neoplasms - diagnosis Pancreatic Neoplasms - pathology Prospective Studies |
| title | Diagnostic performance of a new endoscopic scraper for malignant biliary strictures: a multicenter prospective study |
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