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Mo1305 Development of a Newly Designed Biliary Internal Fistula Tube for Endoscopic Transluminal Biliary Drainage
Abstracts
prospective registry were reviewed retrospectively (27 malignant, 33 benign) by a panel of 3 biliary endoscopists. Each case’s clinical history, ERCP impression and corresponding pCLE sequences was used to score image quality, propose presumptive diagnoses and rate level of diagnostic confidence. Result: Using the Miami classification (MC), the overall accuracy in retrospectively diagnosing malignancy in those 60 cases was 85% (sensitivity; specificity; PPV, NPV: 96,3, 75,76; 76,47%, 96,15%) vs. 78% for the prospective analysis (sensitivity; specificity; PPV, NPV: 96,3, 63,64; 68,42, 95,45%,), reducing the number of false positives for 12 to 8. In a second review, pCLE sequences corresponding to false positive cases (benign inflammatory condition) were reviewed in consensus, blinded to any other information. This review helped explaining 6 of the 8 false positive cases— the pCLE diagnosis was either influenced by the ERCP impression or less than 3 Malignant MC criteria identified in the corresponding pCLE sequences. The careful review of the sequences helped refine the existing MC by identifying four descriptive criteria specific to benign inflammatory conditions. The criteria are: Vascular congestion, roughness aspect, increased inter-glandular space and thickened reticular structure (Figure 1). Conclusion:
Refinement of standardized criteria for diagnosing benign inflammatory strictures improved the overall accuracy of pCLE. A multicenter validation study is required to confirm this data.
Mo1304 Triple Modality Testing by Endoscopic Retrograde Cholangiopancreatography for the Diagnosis of Cholangiocarcinoma Jason M. Brown*, Arjun Nanda, Emir Veledar, Nilofer Kulam, Steven Keilin, Qiang Cai, Field F. Willingham Emory University, Atlanta, GA Background: Brush cytology has a low sensitivity in the diagnosis of cholangiocarcinoma. Additional modalities such as forceps biopsy and fluorescence in-situ hybridization (FISH) have been examined; however the sensitivity has remained low, ranging from 21-57%. A triple modality approach (brush, biopsy, and FISH) has not been examined but could improve sensitivity for the detection of cholangiocarcinoma. Methods: A retrospective review was conducted on patients identified as undergoing endoscopic retrograde cholangiopancreatography (ERCP) for diagnosis of suspected cholangiocarcinoma. Three endoscopists performed ERCP for tissue retrieval from December 2008 to August 2011. Diagnosis of cholangiocarcinoma was confirmed by surgical or anatomic pathology or subsequent clinical outcome. Patients with a prior tissue diagnosis of cholangiocarcinoma were excluded. Brush cytology reported as atypia and equivocal results by FISH were not considered positive for malignancy. Two-tailed P values were computed with a Chi-square with Yates’ correction. Results: A comprehensive ERCP database containing 1239 procedures was reviewed. A total of 118 patients met criteria for inclusion. Of these, 31 were eventually diagnosed with cholangiocarcinoma. Overall, 61 patients underwent brush cytology alone, and 32 patients underwent triple tissue sampling. Brush cytology had a sensitivity of 42% (P value ⬍0.001), a specificity of 100%, a Positive Predictive Value of 100% and a Negative Predictive Value of 88%. Triple tissue sampling had an overall sensitivity of 71% (P value ⬍0.001), a specificity of 100%, a Positive Predictive Value of 100%, and a Negative Predictive Value of 81%. Within the triple tissue group, brush cytology had a sensitivity of 40%, forceps biopsy had a sensitivity of 42%, and FISH analysis had a sensitivity of 57%. Conclusion: A triple modality approach
www.giejournal.org
results in marked increase in sensitivity in the diagnosis of cholangiocarcinoma compared with brush cytology alone and compares favorably with previously published data regarding the sensitivity of dual modality testing. If confirmed in a prospective trial, a triple modality approach during ERCP should be considered for use in the detection of cholangiocarcinoma.
Mo1305 Development of a Newly Designed Biliary Internal Fistula Tube for Endoscopic Transluminal Biliary Drainage Masayasu Aikawa*, Mitsuo Miyazawa, Yosuke Ueno, Katsuya Okada, Osamu Togawa, Yasuko Toshimitsu, Kojun Okamoto, Shigeki Yamaguchi, Isamu Koyama Gastrointestinal Center, Saitama Medical University, International Medical Center, Saitama, Japan Background: A transluminal biliary drainage has recently been performed as an alternative procedures of endoscopic retrograde biliary drainage and percutaneous transhepatic biliary drainage. However, the procedure has the risk for the difficulty to exchange the drainage tube, if biliary-enteric fistula remains incomplete. An ideal drainage tube for transluminal biliary drainage should rapidly make organizing tissue around the tube and firm biliary-enteric fistulae after removal of tube. Aim: We have developed a biliary internal fistula tube (BIFT) which has been constructed with a conventional biliary stent tube and a bioabsorbable polymer seat(BAPS). In this study we attempted to investigate the difference between the BIFT and conventional tube (CT) in biliary-enteric fistula formation. Materials: The BIFT is a 7.5Fr conventional biliary stent tube wrapped with the BAPS, which is 0.5mm thickness. The BAPS is composed of polylactic acid and polycaprolactone reinforced with polyglycolic acid fibers designed to degrade in about 6 weeks. The BAPS is an ideal scaffold for tissue regeneration to allow easy penetration of cells. In an earlier study by our group, the implantation of a bioabsorbable polymer tube as a bypass graft resulted in bile duct regeneration in the graft site after the tube had been degraded and absorbed in the body. Method: BIFT group (n⫽2): The pigs were laparotomized to expose the extrahepatic bile duct (EHBD). Next, the duodenal side of the EHBD below a junction of a cystic duct was ligated. The 5cm BIFT was placed between gallbladder(GB) and duodenum(DU). CT group (n⫽2): The 5cm CT was placed between GB and DU in a similar manner of the BIFT group. In both group these pigs were sacrificed and re-laparotomized at 2 weeks and at 6 weeks after the placement. Results: BIFT group: At 2 weeks after the placement. The BIFT became surrounded by connective tissue between GB and DU. The part of the BAPS remained, but the conventional biliary stent tube has gone. In microscopically the connective tissue had a lot of inflammatory cells and the trace of the BAPS. At 6 weeks after the placement, The distance between GB and DU was shortened. A biliary-enteric fistula, which had 1.5cm bore diameter and 2cm length, was constructed between GB and DU. CT group: At 2 weeks after the placement, the exposed CT was found between GB and DU. At 6 weeks after the placement, the CT became surrounded by connective tissue, and the distance between GB and DU came closer to each other. However, the connective tissue between GB and DU was fragile and easy to be divided. The lumen of the CT has biliary sludge and almost became obstructed. Conclusion: The placement of the BIFT between GB and DU induced rapid and good fistulization, and has the potential for application as a novel device for transluminal biliary drainage avoiding the need for exchange of tubes.
Mo1306 Interobserver Agreement and Diagnostic Accuracy in the Interpretation of Probe-Based Confocal Laser Endomicroscopy of Indeterminate Biliary Strictures: A Pre and Post Training Session Evaluation Jayant P. Talreja1, Brian G. Turner2, Frank G. Gress3, Sammy Ho4, Savreet Sarkaria2, Monica Gaidhane2, Amrita Sethi5, Michel Kahaleh*2 1 Gastroenterology, University of Virginia, Charlottesville, VA; 2Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY; 3Gastroenterology, Downstate, New York, NY; 4 Gastroenterology, Montefiore, New York, NY; 5Gastroenterology, Columbia Medical Center, New York, NY Background: Current diagnostic modalities for diagnosing indeterminate biliary lesions or strictures have low rate of accuracy. Probe-based confocal endomicroscopy (pCLE) permits in vivo microscopic assessment of mucosal structures by obtaining high resolution images of the mucosal layers of the gastrointestinal tract in real time. Previously, an interobserver study demonstrated poor to fair agreement, even within experienced confocal endomicroscopy operators. The objective of this pilot study was to assess the interobserver agreement and improvement of accuracy after holding a teaching session accompanied by a 20 training sequences for the observers. Methods: Forty deidentified pCLE video clips of indeterminate biliary strictures were sent to 5 biliary endoscopists at 4 institutions. After the observers scored these clips, they
Volume 75, No. 4S : 2012
GASTROINTESTINAL ENDOSCOPY
AB382
prospective registry were reviewed retrospectively (27 malignant, 33 benign) by a panel of 3 biliary endoscopists. Each case’s clinical history, ERCP impression and corresponding pCLE sequences was used to score image quality, propose presumptive diagnoses and rate level of diagnostic confidence. Result: Using the Miami classification (MC), the overall accuracy in retrospectively diagnosing malignancy in those 60 cases was 85% (sensitivity; specificity; PPV, NPV: 96,3, 75,76; 76,47%, 96,15%) vs. 78% for the prospective analysis (sensitivity; specificity; PPV, NPV: 96,3, 63,64; 68,42, 95,45%,), reducing the number of false positives for 12 to 8. In a second review, pCLE sequences corresponding to false positive cases (benign inflammatory condition) were reviewed in consensus, blinded to any other information. This review helped explaining 6 of the 8 false positive cases— the pCLE diagnosis was either influenced by the ERCP impression or less than 3 Malignant MC criteria identified in the corresponding pCLE sequences. The careful review of the sequences helped refine the existing MC by identifying four descriptive criteria specific to benign inflammatory conditions. The criteria are: Vascular congestion, roughness aspect, increased inter-glandular space and thickened reticular structure (Figure 1). Conclusion:
Refinement of standardized criteria for diagnosing benign inflammatory strictures improved the overall accuracy of pCLE. A multicenter validation study is required to confirm this data.
Mo1304 Triple Modality Testing by Endoscopic Retrograde Cholangiopancreatography for the Diagnosis of Cholangiocarcinoma Jason M. Brown*, Arjun Nanda, Emir Veledar, Nilofer Kulam, Steven Keilin, Qiang Cai, Field F. Willingham Emory University, Atlanta, GA Background: Brush cytology has a low sensitivity in the diagnosis of cholangiocarcinoma. Additional modalities such as forceps biopsy and fluorescence in-situ hybridization (FISH) have been examined; however the sensitivity has remained low, ranging from 21-57%. A triple modality approach (brush, biopsy, and FISH) has not been examined but could improve sensitivity for the detection of cholangiocarcinoma. Methods: A retrospective review was conducted on patients identified as undergoing endoscopic retrograde cholangiopancreatography (ERCP) for diagnosis of suspected cholangiocarcinoma. Three endoscopists performed ERCP for tissue retrieval from December 2008 to August 2011. Diagnosis of cholangiocarcinoma was confirmed by surgical or anatomic pathology or subsequent clinical outcome. Patients with a prior tissue diagnosis of cholangiocarcinoma were excluded. Brush cytology reported as atypia and equivocal results by FISH were not considered positive for malignancy. Two-tailed P values were computed with a Chi-square with Yates’ correction. Results: A comprehensive ERCP database containing 1239 procedures was reviewed. A total of 118 patients met criteria for inclusion. Of these, 31 were eventually diagnosed with cholangiocarcinoma. Overall, 61 patients underwent brush cytology alone, and 32 patients underwent triple tissue sampling. Brush cytology had a sensitivity of 42% (P value ⬍0.001), a specificity of 100%, a Positive Predictive Value of 100% and a Negative Predictive Value of 88%. Triple tissue sampling had an overall sensitivity of 71% (P value ⬍0.001), a specificity of 100%, a Positive Predictive Value of 100%, and a Negative Predictive Value of 81%. Within the triple tissue group, brush cytology had a sensitivity of 40%, forceps biopsy had a sensitivity of 42%, and FISH analysis had a sensitivity of 57%. Conclusion: A triple modality approach
www.giejournal.org
results in marked increase in sensitivity in the diagnosis of cholangiocarcinoma compared with brush cytology alone and compares favorably with previously published data regarding the sensitivity of dual modality testing. If confirmed in a prospective trial, a triple modality approach during ERCP should be considered for use in the detection of cholangiocarcinoma.
Mo1305 Development of a Newly Designed Biliary Internal Fistula Tube for Endoscopic Transluminal Biliary Drainage Masayasu Aikawa*, Mitsuo Miyazawa, Yosuke Ueno, Katsuya Okada, Osamu Togawa, Yasuko Toshimitsu, Kojun Okamoto, Shigeki Yamaguchi, Isamu Koyama Gastrointestinal Center, Saitama Medical University, International Medical Center, Saitama, Japan Background: A transluminal biliary drainage has recently been performed as an alternative procedures of endoscopic retrograde biliary drainage and percutaneous transhepatic biliary drainage. However, the procedure has the risk for the difficulty to exchange the drainage tube, if biliary-enteric fistula remains incomplete. An ideal drainage tube for transluminal biliary drainage should rapidly make organizing tissue around the tube and firm biliary-enteric fistulae after removal of tube. Aim: We have developed a biliary internal fistula tube (BIFT) which has been constructed with a conventional biliary stent tube and a bioabsorbable polymer seat(BAPS). In this study we attempted to investigate the difference between the BIFT and conventional tube (CT) in biliary-enteric fistula formation. Materials: The BIFT is a 7.5Fr conventional biliary stent tube wrapped with the BAPS, which is 0.5mm thickness. The BAPS is composed of polylactic acid and polycaprolactone reinforced with polyglycolic acid fibers designed to degrade in about 6 weeks. The BAPS is an ideal scaffold for tissue regeneration to allow easy penetration of cells. In an earlier study by our group, the implantation of a bioabsorbable polymer tube as a bypass graft resulted in bile duct regeneration in the graft site after the tube had been degraded and absorbed in the body. Method: BIFT group (n⫽2): The pigs were laparotomized to expose the extrahepatic bile duct (EHBD). Next, the duodenal side of the EHBD below a junction of a cystic duct was ligated. The 5cm BIFT was placed between gallbladder(GB) and duodenum(DU). CT group (n⫽2): The 5cm CT was placed between GB and DU in a similar manner of the BIFT group. In both group these pigs were sacrificed and re-laparotomized at 2 weeks and at 6 weeks after the placement. Results: BIFT group: At 2 weeks after the placement. The BIFT became surrounded by connective tissue between GB and DU. The part of the BAPS remained, but the conventional biliary stent tube has gone. In microscopically the connective tissue had a lot of inflammatory cells and the trace of the BAPS. At 6 weeks after the placement, The distance between GB and DU was shortened. A biliary-enteric fistula, which had 1.5cm bore diameter and 2cm length, was constructed between GB and DU. CT group: At 2 weeks after the placement, the exposed CT was found between GB and DU. At 6 weeks after the placement, the CT became surrounded by connective tissue, and the distance between GB and DU came closer to each other. However, the connective tissue between GB and DU was fragile and easy to be divided. The lumen of the CT has biliary sludge and almost became obstructed. Conclusion: The placement of the BIFT between GB and DU induced rapid and good fistulization, and has the potential for application as a novel device for transluminal biliary drainage avoiding the need for exchange of tubes.
Mo1306 Interobserver Agreement and Diagnostic Accuracy in the Interpretation of Probe-Based Confocal Laser Endomicroscopy of Indeterminate Biliary Strictures: A Pre and Post Training Session Evaluation Jayant P. Talreja1, Brian G. Turner2, Frank G. Gress3, Sammy Ho4, Savreet Sarkaria2, Monica Gaidhane2, Amrita Sethi5, Michel Kahaleh*2 1 Gastroenterology, University of Virginia, Charlottesville, VA; 2Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY; 3Gastroenterology, Downstate, New York, NY; 4 Gastroenterology, Montefiore, New York, NY; 5Gastroenterology, Columbia Medical Center, New York, NY Background: Current diagnostic modalities for diagnosing indeterminate biliary lesions or strictures have low rate of accuracy. Probe-based confocal endomicroscopy (pCLE) permits in vivo microscopic assessment of mucosal structures by obtaining high resolution images of the mucosal layers of the gastrointestinal tract in real time. Previously, an interobserver study demonstrated poor to fair agreement, even within experienced confocal endomicroscopy operators. The objective of this pilot study was to assess the interobserver agreement and improvement of accuracy after holding a teaching session accompanied by a 20 training sequences for the observers. Methods: Forty deidentified pCLE video clips of indeterminate biliary strictures were sent to 5 biliary endoscopists at 4 institutions. After the observers scored these clips, they
Volume 75, No. 4S : 2012
GASTROINTESTINAL ENDOSCOPY
AB382