- Email: [email protected]
741 Novel Endocuff-Assisted Colonoscopy Significantly Increases the Polyp Detection Rate: a Randomized Controlled Trial
Abstracts
740 L-Menthol Sprayed Onto the Colonic Mucosa Increases Polyp Detection During Colonoscopy: a Prospective, Randomized Trial Ken Inoue*1,2, Osamu Dohi3,1, Yasuyuki Gen3,1, Masayasu Jo3,1, Takeshi Mazaki4, Kazuhiko Tokita3, Naohisa Yoshida1, Tetsuya Okayama1, Kazuhiro Kamada1, Kazuhiro Katada1, Kazuhiko Uchiyama1, Ishikawa Takeshi1, Osamu Handa1, Tomohisa Takagi1, Hideyuki Konishi1, Naoki Wakabayashi5, Nobuaki Yagi1, Yuji Naito1, Yoshito Itoh1 1 Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan; 2Center for Critical Illness Research, Lawson Health Research Institute, London, ON, Canada; 3Department of Molecular Gastroenterology and Hepatology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan; 4Department of Surgical Pathology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan; 5Department of Gastroenterology, Otsu City Hospital, Shiga, Japan Background and study aims: Colonoscopy is one of the most reliable methods for the detection of colorectal neoplasms. The adenoma detection rate is an independent predictor of the risk of interval colorectal cancer after screening colonoscopy. However, colonic peristalsis during colonoscopy hides neoplastic lesions and commonly requires an intravenous or intramuscular injection of antispasmodic agents, which sometimes causes unexpected adverse reactions. In upper GI endoscopy, L-menthol, the major constituent of peppermint oil, has suppressed gastric peristalsis. We suspected that L-menthol could be very useful for colonoscopy, if it can be effective against the colonic folds and colonic peristalsis hiding neoplastic lesions. Our goal was to evaluate the efficacy of L-menthol treatment by endoscopic spray in a randomized, single blind, placebo-controlled trial. Patients and methods: A total of 226 patients scheduled to undergo colonoscopy were randomly assigned to receive 320 mg of L-menthol (nZ118) or placebo (nZ108) in a prospective study (UMIN 000007972). Then, 20 mL of 1.6% L-menthol (320 mg) or placebo in a prefilled syringe was directly sprayed on the cecum and through the working channel. In the L-menthol group, L-menthol was sprayed on the colon again if and when intestinal peristalsis occurred. The primary outcome was the difference in the colorectal adenoma detection rate between the groups. The adenoma detection rate was defined as the proportion of screened subjects in whom at least one adenomatous lesion was identified. We converted the evaluated peristaltic grades into a numeric score (Grade0/1/2/3;No/Mild/Moderate/Severe peristalsis). We used the proportion of subjects with no peristalsis after treatment as a secondary outcome and the difference between the paired mean scores (before and after application) as additional secondary outcomes. Results: A total of 289 lesions identified as neoplasms in histological diagnosis were detected in the 226 patients. The baseline data for the patients were not significantly different between the groups. The adenoma detection rate in the L-menthol group was significantly higher than in the placebo group (60.2% vs. 42.6%; PZ0.0083, Chi-square test). The proportion of subjects with no peristalsis after treatment in the L-menthol group was significantly higher than in the placebo group (71.2% vs. 30.9%; P!0.0001, Chi-square test). The peristaltic scores of the patients treated with L-menthol were significantly lower than before treatment (P!0.0001 after treatment, Wilcoxon signed rank test). The scores in the placebo group did not differ significantly from those obtained before treatment. There were no adverse effects in either group. Conclusions: The results suggest that the suppression of colonic peristalsis by L-menthol sprayed directly onto the colonic mucosa improves the adenoma detection rate.
741 Novel Endocuff-Assisted Colonoscopy Significantly Increases the Polyp Detection Rate: a Randomized Controlled Trial Martin Floer1, Erwin Biecker2, Achim Heinecke3, Philipp STRöBel5, Dirk Domagk4, Michael Schepke2, Tobias Meister*1,4 1 Department of Medicine II, HELIOS Albert-Schweitzer-Hospital, Academic Teaching Hospital of the University of Goettingen, Northeim, Germany; 2Department of Gastroenterology, HELIOS Medical Center Siegburg, Siegburg, Germany; 3Department of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany; 4Department of Medicine B, University of Muenster, Muenster, Germany; 5Department of Pathology, University Medical Center Goettingen, Goettingen, Germany Background: Screening colonoscopy for colorectal cancer has proven to reduce mortality rates. Recently the EndocuffÔ(EC), an attachment to the distal tip of the colonoscope, was introduced. The aim of our study was to compare EndocuffÔ (EC)-assisted colonoscopies with standard colonoscopies (SC) for the detection of colonic polyps. Study: This study is a randomized prospective two-center trial. The study was conducted at two tertiary care centers. Participants: 498 patients (249 males, median age 64.0315.56 years) for colon adenoma screening purposes were included. All patients underwent SC with or without the use of Endocuff. Overall polyp detection rate, the number of colonic polyps and the polyp distribution in the colon were measured. Difference in recognition of polyps with or without the use of Endocuff was assessed. Statistical analysis was applied. Results: Total colonoscopy was performed in almost all patients (98% in each group). The mean cleanliness
AB170 GASTROINTESTINAL ENDOSCOPY Volume 79, No. 5S : 2014
score of each group did not differ significantly (EC: 1.35 vs. SC: 1.40, pZ0.284). A total of 634 polyps in the patient cohort could be detected (EC:388 vs. SC: 246 polyps). Overall, we found significant differences in the polyp detection rate and overall number of polyps detected per patient. In the EC group, the number of polyps detected per patient was 63% higher (1.582.64 vs. 0.972.43, p!0.0001). The polyp detection rate in patients increased by 14% with the use of EC (56% vs. 42%, pZ0.001). For polyp detection, superiority by use of EC could be observed in the sigmoid region (pZ0.001) and caecum (pZ0.002) for polyps!1cm in diameter. In the EC group, the adenoma detection rate significantly increased by 86% (EC: 0.912.2 vs. SC: 0.491.3, pZ0.011). No major complications occurred attributable to EC. Conclusions: The use of the EC is feasible and safe with significantly higher polyp detection rates, especially for those located in the sigmoid region. The cuff system has the potential to improve the accuracy of screening colonoscopies.
742 Variable Recognition of Sessile Serrated Adenomas Among Colonoscopists and Pathologists - a Compounded Roadblock to Reducing Interval Colon Cancers Sarah L. Flores*1, Argyrios Ziogas2, Gregory Albers1, Hoda Anton-Culver2, William E. Karnes1 1 Medicine, Division of Gastroenterology, UC Irvine, Orange, CA; 2 Epidemiology, UC Irvine, Orange, CA Background: "Interval cancers" (ICs) occur within 3 years after colonoscopy and represent 7.2-9% of new colorectal cancer (CRC) diagnoses. Most ICs originate in the right colon from missed, incompletely removed, and/or de novo rapidly developing neoplasms. Sessile serrated adenomas (SSA) are candidate precursor lesions based on their subtle flat morphology, right-sided distribution, high incomplete removal rates, and alternative pathway to CRC. Appropriate surveillance depends on recognition of SSAs which can be difficult to find endoscopically and difficult to distinguish pathologically from non-premalignant hyperplastic polyps (HP). Aims: Determine the variability of SSA recognition by colonoscopists and pathologists during routine practice at an academic center. Methods: Colonoscopy and pathology data were collected prospectively as part of our colonoscopy quality program. The dataset analyzed included 1566 colonoscopies performed by 7 colonoscopists between June 2012 and Oct 2013. 2235 polyps were classified by 8 different pathologists. Those classified as adenomas (tubular, tubulovillous, or villous), HPs or SSAs were included in analysis. Polyp detection rate (PDR), adenoma detection rate (ADR), HP detection rate (HDR), and SSA detection rate (SDR) were determined by the number of patients with at least one of the given polyp type per 100. Pathology classification rates were examined on a per polyp basis using the clinically provided diagnosis. Chi-square and Fisher exact methods were used to test differences in detection and classification among endoscopists and pathologists. Results: Among colonoscopists, PDR, ADR, HDR and SDR (range) were 62% (28-68%), 43% (2554%), 22% (9-30%) and 7% (0-14.5%), respectively and varied significantly between colonoscopists (pZ.038). Adenoma classification rates were not significantly different between pathologists (64% [59-69%]). However, classification rates of HP (28% [19-38%]) and SSA (8% [3-21%]) varied significantly between pathologists (p !.0001) and were inversely related (R2Z0.69). SSA/HP ratios ranged between 0.09 and 1.13 among pathologists. Conclusions: Recognition of SSAs is dependent on colonoscopists and pathologists and is worrisomely variable among both groups. If SSAs represent the precursor lesions of ICs, prevention of ICs will require more accurate methodologies for detection of SSAs by colonoscopists and distinction of SSAs from HPs by pathologists.
743 Evaluation of the Clinical Efficacy of Colon Capsule Endoscopy in the Detection of Lesion of the Colon - Prospective Multicenter Study in Japan Shiro Oka*1, Shinji Tanaka1, Yutaka Saito2, Shoichi Saito3, Yasuo Kakugawa2, Minori Matsumoto2, Hiroyuki Aihara3, Ikue Watari1, Taiki Aoyama1, Sadaharu Nouda4, Takanori Kuramoto4, Kenji Watanabe5, Naoki Ohmiya6, Kazuhide Higuchi4, Hidemi Goto6, Tetsuo Arakawa5, Hisao Tajiri3 1 Endoscopy, Hiroshima University Hospital, Hiroshima, Japan; 2 Endoscopy Division, National Cancer Center, Tokyo, Japan; 3 Gastroenterology and Hepatology/Endoscopy, Tokyo Jikei University School of Medicine, Tokyo, Japan; 4The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan; 5Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan; 6 Internal Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan Background and Purpose: PillCam COLON 2 Capsule endoscopy (CCE2, Given Imaging, Yoqneam, Israel) is a relatively new endoscopic method for examining the colon. However, a limited data have been reported, especially with Japanese patients. We conducted a prospective, multi-center, open clinical study to assess the
www.giejournal.org
740 L-Menthol Sprayed Onto the Colonic Mucosa Increases Polyp Detection During Colonoscopy: a Prospective, Randomized Trial Ken Inoue*1,2, Osamu Dohi3,1, Yasuyuki Gen3,1, Masayasu Jo3,1, Takeshi Mazaki4, Kazuhiko Tokita3, Naohisa Yoshida1, Tetsuya Okayama1, Kazuhiro Kamada1, Kazuhiro Katada1, Kazuhiko Uchiyama1, Ishikawa Takeshi1, Osamu Handa1, Tomohisa Takagi1, Hideyuki Konishi1, Naoki Wakabayashi5, Nobuaki Yagi1, Yuji Naito1, Yoshito Itoh1 1 Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan; 2Center for Critical Illness Research, Lawson Health Research Institute, London, ON, Canada; 3Department of Molecular Gastroenterology and Hepatology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan; 4Department of Surgical Pathology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan; 5Department of Gastroenterology, Otsu City Hospital, Shiga, Japan Background and study aims: Colonoscopy is one of the most reliable methods for the detection of colorectal neoplasms. The adenoma detection rate is an independent predictor of the risk of interval colorectal cancer after screening colonoscopy. However, colonic peristalsis during colonoscopy hides neoplastic lesions and commonly requires an intravenous or intramuscular injection of antispasmodic agents, which sometimes causes unexpected adverse reactions. In upper GI endoscopy, L-menthol, the major constituent of peppermint oil, has suppressed gastric peristalsis. We suspected that L-menthol could be very useful for colonoscopy, if it can be effective against the colonic folds and colonic peristalsis hiding neoplastic lesions. Our goal was to evaluate the efficacy of L-menthol treatment by endoscopic spray in a randomized, single blind, placebo-controlled trial. Patients and methods: A total of 226 patients scheduled to undergo colonoscopy were randomly assigned to receive 320 mg of L-menthol (nZ118) or placebo (nZ108) in a prospective study (UMIN 000007972). Then, 20 mL of 1.6% L-menthol (320 mg) or placebo in a prefilled syringe was directly sprayed on the cecum and through the working channel. In the L-menthol group, L-menthol was sprayed on the colon again if and when intestinal peristalsis occurred. The primary outcome was the difference in the colorectal adenoma detection rate between the groups. The adenoma detection rate was defined as the proportion of screened subjects in whom at least one adenomatous lesion was identified. We converted the evaluated peristaltic grades into a numeric score (Grade0/1/2/3;No/Mild/Moderate/Severe peristalsis). We used the proportion of subjects with no peristalsis after treatment as a secondary outcome and the difference between the paired mean scores (before and after application) as additional secondary outcomes. Results: A total of 289 lesions identified as neoplasms in histological diagnosis were detected in the 226 patients. The baseline data for the patients were not significantly different between the groups. The adenoma detection rate in the L-menthol group was significantly higher than in the placebo group (60.2% vs. 42.6%; PZ0.0083, Chi-square test). The proportion of subjects with no peristalsis after treatment in the L-menthol group was significantly higher than in the placebo group (71.2% vs. 30.9%; P!0.0001, Chi-square test). The peristaltic scores of the patients treated with L-menthol were significantly lower than before treatment (P!0.0001 after treatment, Wilcoxon signed rank test). The scores in the placebo group did not differ significantly from those obtained before treatment. There were no adverse effects in either group. Conclusions: The results suggest that the suppression of colonic peristalsis by L-menthol sprayed directly onto the colonic mucosa improves the adenoma detection rate.
741 Novel Endocuff-Assisted Colonoscopy Significantly Increases the Polyp Detection Rate: a Randomized Controlled Trial Martin Floer1, Erwin Biecker2, Achim Heinecke3, Philipp STRöBel5, Dirk Domagk4, Michael Schepke2, Tobias Meister*1,4 1 Department of Medicine II, HELIOS Albert-Schweitzer-Hospital, Academic Teaching Hospital of the University of Goettingen, Northeim, Germany; 2Department of Gastroenterology, HELIOS Medical Center Siegburg, Siegburg, Germany; 3Department of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany; 4Department of Medicine B, University of Muenster, Muenster, Germany; 5Department of Pathology, University Medical Center Goettingen, Goettingen, Germany Background: Screening colonoscopy for colorectal cancer has proven to reduce mortality rates. Recently the EndocuffÔ(EC), an attachment to the distal tip of the colonoscope, was introduced. The aim of our study was to compare EndocuffÔ (EC)-assisted colonoscopies with standard colonoscopies (SC) for the detection of colonic polyps. Study: This study is a randomized prospective two-center trial. The study was conducted at two tertiary care centers. Participants: 498 patients (249 males, median age 64.0315.56 years) for colon adenoma screening purposes were included. All patients underwent SC with or without the use of Endocuff. Overall polyp detection rate, the number of colonic polyps and the polyp distribution in the colon were measured. Difference in recognition of polyps with or without the use of Endocuff was assessed. Statistical analysis was applied. Results: Total colonoscopy was performed in almost all patients (98% in each group). The mean cleanliness
AB170 GASTROINTESTINAL ENDOSCOPY Volume 79, No. 5S : 2014
score of each group did not differ significantly (EC: 1.35 vs. SC: 1.40, pZ0.284). A total of 634 polyps in the patient cohort could be detected (EC:388 vs. SC: 246 polyps). Overall, we found significant differences in the polyp detection rate and overall number of polyps detected per patient. In the EC group, the number of polyps detected per patient was 63% higher (1.582.64 vs. 0.972.43, p!0.0001). The polyp detection rate in patients increased by 14% with the use of EC (56% vs. 42%, pZ0.001). For polyp detection, superiority by use of EC could be observed in the sigmoid region (pZ0.001) and caecum (pZ0.002) for polyps!1cm in diameter. In the EC group, the adenoma detection rate significantly increased by 86% (EC: 0.912.2 vs. SC: 0.491.3, pZ0.011). No major complications occurred attributable to EC. Conclusions: The use of the EC is feasible and safe with significantly higher polyp detection rates, especially for those located in the sigmoid region. The cuff system has the potential to improve the accuracy of screening colonoscopies.
742 Variable Recognition of Sessile Serrated Adenomas Among Colonoscopists and Pathologists - a Compounded Roadblock to Reducing Interval Colon Cancers Sarah L. Flores*1, Argyrios Ziogas2, Gregory Albers1, Hoda Anton-Culver2, William E. Karnes1 1 Medicine, Division of Gastroenterology, UC Irvine, Orange, CA; 2 Epidemiology, UC Irvine, Orange, CA Background: "Interval cancers" (ICs) occur within 3 years after colonoscopy and represent 7.2-9% of new colorectal cancer (CRC) diagnoses. Most ICs originate in the right colon from missed, incompletely removed, and/or de novo rapidly developing neoplasms. Sessile serrated adenomas (SSA) are candidate precursor lesions based on their subtle flat morphology, right-sided distribution, high incomplete removal rates, and alternative pathway to CRC. Appropriate surveillance depends on recognition of SSAs which can be difficult to find endoscopically and difficult to distinguish pathologically from non-premalignant hyperplastic polyps (HP). Aims: Determine the variability of SSA recognition by colonoscopists and pathologists during routine practice at an academic center. Methods: Colonoscopy and pathology data were collected prospectively as part of our colonoscopy quality program. The dataset analyzed included 1566 colonoscopies performed by 7 colonoscopists between June 2012 and Oct 2013. 2235 polyps were classified by 8 different pathologists. Those classified as adenomas (tubular, tubulovillous, or villous), HPs or SSAs were included in analysis. Polyp detection rate (PDR), adenoma detection rate (ADR), HP detection rate (HDR), and SSA detection rate (SDR) were determined by the number of patients with at least one of the given polyp type per 100. Pathology classification rates were examined on a per polyp basis using the clinically provided diagnosis. Chi-square and Fisher exact methods were used to test differences in detection and classification among endoscopists and pathologists. Results: Among colonoscopists, PDR, ADR, HDR and SDR (range) were 62% (28-68%), 43% (2554%), 22% (9-30%) and 7% (0-14.5%), respectively and varied significantly between colonoscopists (pZ.038). Adenoma classification rates were not significantly different between pathologists (64% [59-69%]). However, classification rates of HP (28% [19-38%]) and SSA (8% [3-21%]) varied significantly between pathologists (p !.0001) and were inversely related (R2Z0.69). SSA/HP ratios ranged between 0.09 and 1.13 among pathologists. Conclusions: Recognition of SSAs is dependent on colonoscopists and pathologists and is worrisomely variable among both groups. If SSAs represent the precursor lesions of ICs, prevention of ICs will require more accurate methodologies for detection of SSAs by colonoscopists and distinction of SSAs from HPs by pathologists.
743 Evaluation of the Clinical Efficacy of Colon Capsule Endoscopy in the Detection of Lesion of the Colon - Prospective Multicenter Study in Japan Shiro Oka*1, Shinji Tanaka1, Yutaka Saito2, Shoichi Saito3, Yasuo Kakugawa2, Minori Matsumoto2, Hiroyuki Aihara3, Ikue Watari1, Taiki Aoyama1, Sadaharu Nouda4, Takanori Kuramoto4, Kenji Watanabe5, Naoki Ohmiya6, Kazuhide Higuchi4, Hidemi Goto6, Tetsuo Arakawa5, Hisao Tajiri3 1 Endoscopy, Hiroshima University Hospital, Hiroshima, Japan; 2 Endoscopy Division, National Cancer Center, Tokyo, Japan; 3 Gastroenterology and Hepatology/Endoscopy, Tokyo Jikei University School of Medicine, Tokyo, Japan; 4The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan; 5Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan; 6 Internal Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan Background and Purpose: PillCam COLON 2 Capsule endoscopy (CCE2, Given Imaging, Yoqneam, Israel) is a relatively new endoscopic method for examining the colon. However, a limited data have been reported, especially with Japanese patients. We conducted a prospective, multi-center, open clinical study to assess the
www.giejournal.org