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Peroral Cholangioscopy (PO) Using a Disposable Steerable Single Operator Catheter for Biliary Stone Therapy and Assessment of Indeterminate Strictures - A Multi-Center Experience Using Spyglass
Abstracts
complications. CPs were extracted. A data collection sheet included indications, interventions, complications by consensus criteria, and other adverse events (unplanned medical evaluation, cardiopulmonary, sedation-related, infection). Patients undergoing sphincter of Oddi manometry (SOM) were excluded. STATA 8.2 was used for analyses. Results: Between July 2001 and October 2007, a total of 4214 ERCP’s were performed, of which 337 (8.0%) were SOM and excluded. Of the 3877 remaining ERCP’s, CP was performed in 402 (10.4%). 129 adverse events (AE) were reported and analyzed (101 after ERCPs, 28 after CPs). In patients with AEs, indications for ERCP and CP, respectively, included: evaluation of biliary (CBD) (35.6%, 46.4%) and pancreatic (PD) stricture (16.8%, 17.9%), therapy of CBD stones (16.8% and 32.1%) and PD stones (6.9% and 10.7%); sphincterotomies were performed in 59.4% and 28.6% of procedures. Pancreatoscopy comprised 7/28 (25.0%) of CPs. Interventions performed at time of ERCP with CP in patients with AEs: CBD (N Z 4) and PD (N Z 3) stricture dilation, CBD (N Z 15) and PD (N Z 4) tissue sampling, CBD (N Z 4) and PD (N Z 2) EHL, and prophylactic or therapeutic PD stents (N Z 5). CP diagnoses included CBD (N Z 5) and PD stones (n Z 3), PSC (n Z 3), CCA (n Z 6), chronic pancreatitis (n Z 2), IPMN (n Z 4), and other (n Z 5). Reported AEs (see Table) were significantly higher in the CP compared to ERCP group [28/402 (7.0%) vs 101/3475 (2.9%)], (OR 2.50, 95% CI [1.56-3.89]). Subgroup analyses revealed a significantly higher rate of cholangitis (1.0% vs 0.2%, OR 4.98, 95%CI [1.06-19.67]) and a trend toward a higher rate of pancreatitis (2.2% vs 1.3%, OR 1.75, 95%CI [0.74-3.65])and perforation (1.0% vs 0.3%, OR 3.16, 95%CI [0.73-10.75] in the CP group. Conclusions: 1) Adverse events for cholangiopancreatoscopy are more than double that of ERCP when SOM patients are excluded. 2) CP is associated with significantly higher consensus criteria complications 3) Subgroup analysis showed significantly higher rates of cholangitis in the CP group likely related to fluid irrigation 4) The increased risk for complications should be discussed with patients undergoing ERCP when CP is planned. Consensus Complications and Other Adverse Events Procedures Unplanned with Medical Cardiopulmonary/ Complications Pancreatitis) Perforation) Bleeding) Cholangitis) Evaluation Sedation Events Other CP(N Z 28) ERCP(N Z 101)
9 45
4 11
0 12
4 7
6 8
2 10
3 8
869 Intraductal Balloon Guided Direct Peroral Cholangioscopy Using An Ultra-Slim Upper Endoscope Jong Ho Moon, Bong Min Ko, Hyun Jong Choi, Su Jin Hong, Hyun Cheol Koo, Young Koog Cheon, Young Deok Cho, Joon Seong Lee, Moon Sung Lee, Chan Sup Shim Background and Aims: Peroral cholangioscopy provides direct visualization of the bile duct and permits diagnostic procedures or therapeutic interventions. Currently available the ‘‘mother-baby’’ scope system is not widely used because of several limitations. Endoscopic direct cholangioscopy by using an ultra-slim upper endoscope with a guidewire was reported as one of easy way to make direct visual examination of the biliary tree. However, the success is not always guaranteed. The aim of this study was to evaluate the feasibility and success rate of direct peroral cholangioscopy (direct POC) using an ultra-slim endoscope with an intraductal balloon to maintain access compared with a guidewire method. Patients and Methods; From August 2006 to November 2007, twenty one patients with biliary diseases underwent direct POC. All patients underwent an endoscopic sphincterotomy or papillary balloon dilation with large balloon. Ten patients underwent wire-guided direct POC. Intraductal balloon guided direct POC was performed in 15 patients. Using a balloon catheter to maintain access, an ultra-slim upper endoscope (GIF-N260 or GIF-N230; Olympus Co., Japan) was advanced over the balloon catheter directly into the bile duct through ampulla of Vater. The success of cholangioscopy was defined as advance of the endoscope into the bifurcation. Overall success rate was compared. Results: Wire-guided direct POC was performed successfully in 5 of 10 patients (50%). The success rate of intraductal balloon guided direct POC was 93.3% (14/ 15 patients).(p ! 0.05) Forceps biopsy under direct visualization of the intraductal lesions, therapeutic interventions including laser lithotripsy or electrohydraulic lithotripsy were performed successfully. Procedure related complication was not occurred in all patients. Conclusions: Intraductal balloon guided direct peroral cholangioscopy seems to be one of novel procedure to direct visual examination of bile ducts for a selected group of patients with biliary disease. Continuous development of endoscope and accessories is expecting to facilitate performing direct peroral cholangioscopy.
)Total complications by consensus criteria was significantly higher for ERCP with CP (4.2% vs 2.2%. OR 2.00, 95%CI [1.10-3.46]
868 Peroral Cholangioscopy (PO) Using a Disposable Steerable Single Operator Catheter for Biliary Stone Therapy and Assessment of Indeterminate Strictures - A Multi-Center Experience Using Spyglass Yang K. Chen, Mansour a. Parsi, Kenneth F. Binmoeller, Robert H. Hawes, Douglas Pleskow, Adam Slivka, Oleh Haluszka, Bret T. Petersen, Stuart Sherman, Jacques Deviere, Soren Meisner, Peter D. Stevens, Guido Costamagna, Thierry Ponchon, Horst Neuhaus Introduction: PO has been used to detect biliary (BD) pathology, guide stone therapy and obtain biopsies but widespread use has been hampered by fragility, limited steerability, poor irrigation capabilities, and need for second operator. Methods:15 center 12 mo follow-up registry will document performance and utility of PO using SpyGlass DVS system (Boston Scientific, Natick,USA) in 300 pts requiring PO for stone therapy or investigation of suspected pathology with or without biopsy. SpyGlass DVS consists of disposable catheter with 4-way tip deflection, dedicated irrigation/working channels, multi-use fiberoptic light/image guide, and disposable biopsy forceps. Procedural success defined as ability to visualize target lesion/obtain biopsies or initiate stone therapy. Results: 146 pts enrolled with ongoing accrual. PO indications: indeterminate strictures non-PSC (39%), stone management (34%), rule out cancer in PSC (10%), other non-diagnostic ERCP findings (8%), indeterminate filling defect (6%), other (4%). Sites of interest were in CBD (56%), CHD and hilum (55%), main hepatic ducts (23%), intrahepatic (8%), ampulla (3%). Biopsies taken in 40% of pts with a mean of 3.7 specimens. Procedural success was 89% overall, 92% in stone group, 88% in biopsy group, and 86% in cases with visual assessment only; access to target site was unsuccessful in 4. All cases were performed by single operator. Visual diagnosis (DX) was discordant from ERCP diagnosis in 21%. PO confirmed or excluded presence of pathologic lesion in all pts with indeterminate filling defects. Biopsy results and benign vs malignant visual DX and 30 d follow-up are available on 45 pts to date. Concordance between visual DX and biopsy results was 71%. PPV and NPV of visual DX for biopsy results were 57% and 89% respectively. At 30 d preliminary sensitivity and specificity of biopsy relative to clinical DX of malignancy are 90% and 89% respectively. There were 5 deaths, none related to devices or procedures, and 14 serious adverse event related to device and/or procedures: 4 (2.7%) cholangitis, 2 (1.4%) bacteremia, 2 (1.4%) abdominal pain, 1 (0.7%) each of pancreatitis, liver abscess, abdominal distension, nausea, transient hypotension, and radiculopathy. Conclusions: Interim analysis demonstrates that PO using Spyglass DVS System can be safely performed by single operator, provides reliable access to target sites for visual inspection, stone therapy and tissue sampling, and obtains adequate histologic samples. Visual DX combined with directed tissue sampling using the new Spyglass system may improve accuracy of diagnosis in pts with indeterminate bile duct lesions.
www.giejournal.org
870 Biopsy of Indeterminate Biliary Strictures - Does Direct Visualization Help? - A Multicener Experience Douglas Pleskow, Mansour a. Parsi, Yang K. Chen, Horst Neuhaus, Adam Slivka, Oleh Haluszka, Bret T. Petersen, Jacques Deviere, Stuart Sherman, SøRen Meisner, Robert H. Hawes, Peter D. Stevens, Thierry Ponchon, Guido Costamagna, Kenneth F. Binmoeller Background & Aim: Endoscopic retrograde cholangiography (ERC)-guided brushings and biopsies of indeterminate biliary strictures have low sensitivity for detection of malignancy. Targeted biopsies under direct visualization by peroral cholangioscopy may improve diagnostic sensitivity of intraductal biopsies. Methods: As part of an international multicenter registry, 60 patients with indeterminate biliary strictures or filling defects underwent ERC followed by peroral cholangioscopy using SpyGlass Direct Visualization System (Boston Scientific, Natick, USA). This system includes a reusable optical probe and a disposable catheter with 4-way tip deflection, dedicated irrigation channels, and 1.2 mm working channel accommodating the disposable SpyBite biopsy forceps. Procedural success was defined as ability to visualize target lesion and obtain adequate biopsies for histology. Per protocol, patients with benign biopsies undergo 12 months of follow-up or until definitive diagnosis of malignancy is established, whereas those with biopsies consistent with malignancy undergo 1 month of follow-up. Approximately 50% of patients have 6 months of follow-up. Enrollment and follow-up are ongoing. Results: Indications for cholangioscopy with biopsy were indeterminate strictures in nonPSC patients (62%), dominant PSC strictures (14%), non-diagnostic prior tissue sampling (10%), indeterminate filling defects (7%), non-diagnostic prior ERC findings (2%), and other (5%). Biopsies were obtained in CBD (36%), Hilum (26%), CHD (24%), LHD (10%), and RHD (5%). Procedural success was achieved in 53/60 (88%) of patients. Ability to obtain biopsy was reported as good or excellent in 76%, fair in 20% and poor in 3% of cases. Mean number of biopsy attempts per patient was 4.4 and mean number of biopsies obtained per patient was 3.7. Amount of tissue obtained was deemed adequate in 87% of the cases. Sensitivity, specificity, PPV and NPV of biopsies for detection of malignancy in 29 patients who had at least 6 months of follow-up were 78%, 100%, 100% and 60% respectively. There were 5 deaths, none related to devices or ERC or cholangioscopy procedures. There were 8 serious device and/or procedure related adverse event, 6 resolved without sequelae and 2 are resolving: 2 cholangitis (3.3%), 2 bacteremia (3.3%), 1 liver abscess with sepsis and cholangitis (1.7%), 1 nausea (1.7%), 1 transient hypotension (1.7%), and 1 radiculopathy (1.7%). Conclusions: Targeted biopsies using SpyGlass DVS is feasible, safe and well tolerated. Biliary biopsies obtained under direct visualization by peroral cholangioscopy have high sensitivity for diagnosis of pancreatobiliary malignancies.
Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB103
complications. CPs were extracted. A data collection sheet included indications, interventions, complications by consensus criteria, and other adverse events (unplanned medical evaluation, cardiopulmonary, sedation-related, infection). Patients undergoing sphincter of Oddi manometry (SOM) were excluded. STATA 8.2 was used for analyses. Results: Between July 2001 and October 2007, a total of 4214 ERCP’s were performed, of which 337 (8.0%) were SOM and excluded. Of the 3877 remaining ERCP’s, CP was performed in 402 (10.4%). 129 adverse events (AE) were reported and analyzed (101 after ERCPs, 28 after CPs). In patients with AEs, indications for ERCP and CP, respectively, included: evaluation of biliary (CBD) (35.6%, 46.4%) and pancreatic (PD) stricture (16.8%, 17.9%), therapy of CBD stones (16.8% and 32.1%) and PD stones (6.9% and 10.7%); sphincterotomies were performed in 59.4% and 28.6% of procedures. Pancreatoscopy comprised 7/28 (25.0%) of CPs. Interventions performed at time of ERCP with CP in patients with AEs: CBD (N Z 4) and PD (N Z 3) stricture dilation, CBD (N Z 15) and PD (N Z 4) tissue sampling, CBD (N Z 4) and PD (N Z 2) EHL, and prophylactic or therapeutic PD stents (N Z 5). CP diagnoses included CBD (N Z 5) and PD stones (n Z 3), PSC (n Z 3), CCA (n Z 6), chronic pancreatitis (n Z 2), IPMN (n Z 4), and other (n Z 5). Reported AEs (see Table) were significantly higher in the CP compared to ERCP group [28/402 (7.0%) vs 101/3475 (2.9%)], (OR 2.50, 95% CI [1.56-3.89]). Subgroup analyses revealed a significantly higher rate of cholangitis (1.0% vs 0.2%, OR 4.98, 95%CI [1.06-19.67]) and a trend toward a higher rate of pancreatitis (2.2% vs 1.3%, OR 1.75, 95%CI [0.74-3.65])and perforation (1.0% vs 0.3%, OR 3.16, 95%CI [0.73-10.75] in the CP group. Conclusions: 1) Adverse events for cholangiopancreatoscopy are more than double that of ERCP when SOM patients are excluded. 2) CP is associated with significantly higher consensus criteria complications 3) Subgroup analysis showed significantly higher rates of cholangitis in the CP group likely related to fluid irrigation 4) The increased risk for complications should be discussed with patients undergoing ERCP when CP is planned. Consensus Complications and Other Adverse Events Procedures Unplanned with Medical Cardiopulmonary/ Complications Pancreatitis) Perforation) Bleeding) Cholangitis) Evaluation Sedation Events Other CP(N Z 28) ERCP(N Z 101)
9 45
4 11
0 12
4 7
6 8
2 10
3 8
869 Intraductal Balloon Guided Direct Peroral Cholangioscopy Using An Ultra-Slim Upper Endoscope Jong Ho Moon, Bong Min Ko, Hyun Jong Choi, Su Jin Hong, Hyun Cheol Koo, Young Koog Cheon, Young Deok Cho, Joon Seong Lee, Moon Sung Lee, Chan Sup Shim Background and Aims: Peroral cholangioscopy provides direct visualization of the bile duct and permits diagnostic procedures or therapeutic interventions. Currently available the ‘‘mother-baby’’ scope system is not widely used because of several limitations. Endoscopic direct cholangioscopy by using an ultra-slim upper endoscope with a guidewire was reported as one of easy way to make direct visual examination of the biliary tree. However, the success is not always guaranteed. The aim of this study was to evaluate the feasibility and success rate of direct peroral cholangioscopy (direct POC) using an ultra-slim endoscope with an intraductal balloon to maintain access compared with a guidewire method. Patients and Methods; From August 2006 to November 2007, twenty one patients with biliary diseases underwent direct POC. All patients underwent an endoscopic sphincterotomy or papillary balloon dilation with large balloon. Ten patients underwent wire-guided direct POC. Intraductal balloon guided direct POC was performed in 15 patients. Using a balloon catheter to maintain access, an ultra-slim upper endoscope (GIF-N260 or GIF-N230; Olympus Co., Japan) was advanced over the balloon catheter directly into the bile duct through ampulla of Vater. The success of cholangioscopy was defined as advance of the endoscope into the bifurcation. Overall success rate was compared. Results: Wire-guided direct POC was performed successfully in 5 of 10 patients (50%). The success rate of intraductal balloon guided direct POC was 93.3% (14/ 15 patients).(p ! 0.05) Forceps biopsy under direct visualization of the intraductal lesions, therapeutic interventions including laser lithotripsy or electrohydraulic lithotripsy were performed successfully. Procedure related complication was not occurred in all patients. Conclusions: Intraductal balloon guided direct peroral cholangioscopy seems to be one of novel procedure to direct visual examination of bile ducts for a selected group of patients with biliary disease. Continuous development of endoscope and accessories is expecting to facilitate performing direct peroral cholangioscopy.
)Total complications by consensus criteria was significantly higher for ERCP with CP (4.2% vs 2.2%. OR 2.00, 95%CI [1.10-3.46]
868 Peroral Cholangioscopy (PO) Using a Disposable Steerable Single Operator Catheter for Biliary Stone Therapy and Assessment of Indeterminate Strictures - A Multi-Center Experience Using Spyglass Yang K. Chen, Mansour a. Parsi, Kenneth F. Binmoeller, Robert H. Hawes, Douglas Pleskow, Adam Slivka, Oleh Haluszka, Bret T. Petersen, Stuart Sherman, Jacques Deviere, Soren Meisner, Peter D. Stevens, Guido Costamagna, Thierry Ponchon, Horst Neuhaus Introduction: PO has been used to detect biliary (BD) pathology, guide stone therapy and obtain biopsies but widespread use has been hampered by fragility, limited steerability, poor irrigation capabilities, and need for second operator. Methods:15 center 12 mo follow-up registry will document performance and utility of PO using SpyGlass DVS system (Boston Scientific, Natick,USA) in 300 pts requiring PO for stone therapy or investigation of suspected pathology with or without biopsy. SpyGlass DVS consists of disposable catheter with 4-way tip deflection, dedicated irrigation/working channels, multi-use fiberoptic light/image guide, and disposable biopsy forceps. Procedural success defined as ability to visualize target lesion/obtain biopsies or initiate stone therapy. Results: 146 pts enrolled with ongoing accrual. PO indications: indeterminate strictures non-PSC (39%), stone management (34%), rule out cancer in PSC (10%), other non-diagnostic ERCP findings (8%), indeterminate filling defect (6%), other (4%). Sites of interest were in CBD (56%), CHD and hilum (55%), main hepatic ducts (23%), intrahepatic (8%), ampulla (3%). Biopsies taken in 40% of pts with a mean of 3.7 specimens. Procedural success was 89% overall, 92% in stone group, 88% in biopsy group, and 86% in cases with visual assessment only; access to target site was unsuccessful in 4. All cases were performed by single operator. Visual diagnosis (DX) was discordant from ERCP diagnosis in 21%. PO confirmed or excluded presence of pathologic lesion in all pts with indeterminate filling defects. Biopsy results and benign vs malignant visual DX and 30 d follow-up are available on 45 pts to date. Concordance between visual DX and biopsy results was 71%. PPV and NPV of visual DX for biopsy results were 57% and 89% respectively. At 30 d preliminary sensitivity and specificity of biopsy relative to clinical DX of malignancy are 90% and 89% respectively. There were 5 deaths, none related to devices or procedures, and 14 serious adverse event related to device and/or procedures: 4 (2.7%) cholangitis, 2 (1.4%) bacteremia, 2 (1.4%) abdominal pain, 1 (0.7%) each of pancreatitis, liver abscess, abdominal distension, nausea, transient hypotension, and radiculopathy. Conclusions: Interim analysis demonstrates that PO using Spyglass DVS System can be safely performed by single operator, provides reliable access to target sites for visual inspection, stone therapy and tissue sampling, and obtains adequate histologic samples. Visual DX combined with directed tissue sampling using the new Spyglass system may improve accuracy of diagnosis in pts with indeterminate bile duct lesions.
www.giejournal.org
870 Biopsy of Indeterminate Biliary Strictures - Does Direct Visualization Help? - A Multicener Experience Douglas Pleskow, Mansour a. Parsi, Yang K. Chen, Horst Neuhaus, Adam Slivka, Oleh Haluszka, Bret T. Petersen, Jacques Deviere, Stuart Sherman, SøRen Meisner, Robert H. Hawes, Peter D. Stevens, Thierry Ponchon, Guido Costamagna, Kenneth F. Binmoeller Background & Aim: Endoscopic retrograde cholangiography (ERC)-guided brushings and biopsies of indeterminate biliary strictures have low sensitivity for detection of malignancy. Targeted biopsies under direct visualization by peroral cholangioscopy may improve diagnostic sensitivity of intraductal biopsies. Methods: As part of an international multicenter registry, 60 patients with indeterminate biliary strictures or filling defects underwent ERC followed by peroral cholangioscopy using SpyGlass Direct Visualization System (Boston Scientific, Natick, USA). This system includes a reusable optical probe and a disposable catheter with 4-way tip deflection, dedicated irrigation channels, and 1.2 mm working channel accommodating the disposable SpyBite biopsy forceps. Procedural success was defined as ability to visualize target lesion and obtain adequate biopsies for histology. Per protocol, patients with benign biopsies undergo 12 months of follow-up or until definitive diagnosis of malignancy is established, whereas those with biopsies consistent with malignancy undergo 1 month of follow-up. Approximately 50% of patients have 6 months of follow-up. Enrollment and follow-up are ongoing. Results: Indications for cholangioscopy with biopsy were indeterminate strictures in nonPSC patients (62%), dominant PSC strictures (14%), non-diagnostic prior tissue sampling (10%), indeterminate filling defects (7%), non-diagnostic prior ERC findings (2%), and other (5%). Biopsies were obtained in CBD (36%), Hilum (26%), CHD (24%), LHD (10%), and RHD (5%). Procedural success was achieved in 53/60 (88%) of patients. Ability to obtain biopsy was reported as good or excellent in 76%, fair in 20% and poor in 3% of cases. Mean number of biopsy attempts per patient was 4.4 and mean number of biopsies obtained per patient was 3.7. Amount of tissue obtained was deemed adequate in 87% of the cases. Sensitivity, specificity, PPV and NPV of biopsies for detection of malignancy in 29 patients who had at least 6 months of follow-up were 78%, 100%, 100% and 60% respectively. There were 5 deaths, none related to devices or ERC or cholangioscopy procedures. There were 8 serious device and/or procedure related adverse event, 6 resolved without sequelae and 2 are resolving: 2 cholangitis (3.3%), 2 bacteremia (3.3%), 1 liver abscess with sepsis and cholangitis (1.7%), 1 nausea (1.7%), 1 transient hypotension (1.7%), and 1 radiculopathy (1.7%). Conclusions: Targeted biopsies using SpyGlass DVS is feasible, safe and well tolerated. Biliary biopsies obtained under direct visualization by peroral cholangioscopy have high sensitivity for diagnosis of pancreatobiliary malignancies.
Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB103