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Cost Analysis of Temporarily Placed Covered Self Expandable Metallic Stents Versus Plastic Stents in Biliary Strictures Related to Chronic Pancreatitis
Abstracts
M1263 Methylene Blue Aided Cholangioscopy in Patients with Biliary Strictures-A Novel Method to Detect GI Malignancies Arthur Hoffman, Ralf Kiesslich, Peter R. Galle, Markus Neurath Introduction: Cholangioscopy (CA) in patients with biliary strictures possible increases the diagnostic yield of neoplastic changes. Chromoendoscopy with methylene blue is mainly used in the lower GI tract to delineate neoplastic lesions. Thus, aim of the current study was to perform methylene blue aided cholangioscopy for early detection of biliary neoplasia or specific diagnosis of biliary strictures. Methods: Consecutive patients with newly suspected biliary lesions (ultrasonography or MRI), long standing primary sclerosing cholangitis (PSC) or after orthotopic liver transplantation (OLT) with newly developed biliary strictures were scheduled for ERCP with subsequent cholangioscopy (Pentax FCP-9P). After initial inspection of all reachable biliary segments with CA chromoendoscopy with 15 ml methylene blue (0.1%) was performed via working channel of the cholangioscope. Access dye was removed by suction after 3 minutes waiting time. Newly appearing circumscribed or unstained lesions were noted, recorded and judged according to their macroscopic type and staining features. Methylene blue aided diagnosis was compared with directed biopsies or surgery. Results:A total of 53 patients [biliary stenosis or cholestasis of unknown origin (n Z 23), stenosis after OLT (n Z 23), PSC (n Z 7)] were included. Methylene blue aided cholangioscopy unmasked 48 lesions in 33 patients. Diffuse staining pattern were seen in chronic inflammation (n Z 14 patients) and ischemic type biliary lesions (n Z 19 patients). Unstained or weak stained circumscribed lesions were identified in 4 patients. Final histology confirmed neoplasia (n Z 3 bile duct cancer, n Z 1 hepatocellular carcinoma) in all cases. CA revealed no severe side effects. However, some patients developed a transient discoloration of the urine. Conclusion: Methylene blue aided cholangioscopy is a feasible and safe tool improving the diagnostic yield of biliary strictures. Methylene blue negative staining in circumscribed lesions is a sensitive marker for the presence of neoplastic changes whereas a diffuse staining pattern predicts chronic inflammation. This novel method may be an ideal tool for early detection and diagnosis of biliary malignancies.
M1265 Synergistic Sedation with Oral Midazolam As a Premedication and Intravenous Propofol Titrated to Deep Sedation Versus Intravenous Propofol Titrated to Deep Sedation in ERCP. A Prospective, Randomized Study Maria Manolaraki, Emmanouil Vardas, Angeliki Theodoropoulou, Kostantinos Psaras, Emmanouil Manolakakis, Gregorios Chlouverakis, Gregorios Paspatis Background and Aims: Disadvantages of propofol are lack of a reversal agent and the ability to induce rapid respiratory depression. In contrast to other sedatives propofol has a very narrow therapeutic window. Synergistic sedation with low doses of intravenous (IV) midazolam and propofol reduces significantly the required dose of propofol and therefore the risk of complications. The primary objective of the present study was to compare the required dose of IV propofol between Group A (synergistic sedation with an oral dose of midazolam as premedication combined with IV propofol) and Group B (IV propofol alone) in ERCP. The secondary objective was to compare the patients’ anxiety level before the procedure, the patients’ satisfaction, the recovery times as well as other end points. To the best of our knowledge, this is the only prospective, randomized, comparative study on this subject. Methods: 70 consecutive patients undergoing ERCP were randomly assigned to 1 of the 2 medication regimens. Patients in group A (n Z 37, 14 men, 23 women, mean age 74 yr) received 7.5 mg of midazolam orally and 30 min later IV propofol was given titrated to deep sedation. Patients in group B (n Z 33, 9 men, 24 women, mean age 69 yr) received only IV propofol titrated to deep sedation. Results: Patients receiving propofol alone required higher doses of propofol compared with synergistic sedation (495 243 mg versus 348 248 mg, respectively, p Z 0.01). Patients’ anxiety before the procedure was higher in group B patients compared to those of group A (p ! 0.05). There were no significant differences in vital signs, oxygen saturations, end tidal CO2 or recovery times between the two groups. Patients’ satisfaction was higher in group A patients compared to those of group B, however, the results did not reach a statistically significant level. Multivariate stepwise regression analysis revealed that among sex, age, duration of the procedure, ASA grade and the type of sedation, the type of sedation, the age and the duration of the procedure were the factors significantly associated with the required dose of intravenous propofol. Conclusions: Our data suggest that the synergistic sedation with an oral dose of midazolam combined with IV propofol may provide a significant benefit with regards to a required lower dose of propofol used and the patients’ anxiety before the procedure in ERCP.
M1264 A Prospective Evaluation of Post ERCP Pancreatitis and Precut Needle Knife Sphincterotomy in Difficult Biliary Cannulation Adam A. Bailey, Arthur Kaffes, Stephen J. Williams, Eric Lee, Michael J. Bourke
M1266 Cost Analysis of Temporarily Placed Covered Self Expandable Metallic Stents Versus Plastic Stents in Biliary Strictures Related to Chronic Pancreatitis Brian W. Behm, Andrew Brock, Bridger W. Clarke, Reid B. Adams, Patrick G. Northup, Paul Yeaton, Michel Kahaleh
Background: In the absence of precut needle knife sphincterotomy (NKS), failure of biliary cannulation occurs in approximately 10% of cases. There are few prospective evaluations of the safety and efficacy of NKS and studies of its early use in difficult cannulation have been inconclusive. Whether pre-cut needle knife sphincterotomy after failure of primary biliary cannulation is independently associated with PEP remains controversial. Aim: The aim of this study was to examine the relationship between needle knife sphincterotomy and PEP. Methods: 736 patients with an intact papilla were enrolled in successive, prospective randomized studies that failed to show a reduction in PEP. (1. Glyceryl trinitrate versus placebo and 2. primary guidewire versus contrast cannulation). Patients with pancreatic or ampullary cancer were excluded as PEP is infrequent in this subgroup. The fellow commenced the majority of cases. If unsuccessful after a maximum of 10 minutes, the consultant then attempted for a further maximum of 10 min prior to NKS for failed initial cannulation. Pancreatic stenting prior to NKS was performed at discretion to facilitate biliary localization and protect the pancreatic orifice. Cannulation parameters were recorded prospectively and 24h and 30 day complication rates were assessed by phone interview and 24h serum amylase and lipase level. Results: NKS was performed in 94 of 734 patients (12.8%) and was successful in achieving bile duct access in 80/94 (85%). Cannulation success in the entire group was 717/734 (97.7%). The overall frequency of pancreatitis following needle knife sphincterotomy was 14.9% (14/94) compared to 6.5% without (p ! 0.001). Pancreatitis increased with increasing number of attempts at the papilla. In multivariate analysis, independent predictors of PEP were: female gender (OR Z 3.5, p Z 0.028), suspected SOD (OR Z 9.7, p ! 0.001), partial pancreatic drainage (OR Z 4.8, p Z 0.011), 10 to 14 attempts at papilla (OR Z 4.4, p Z 0.031) and R 15 attempts at papilla (OR Z 9.4, p Z 0.013). Pancreatic stents were inserted in 22 patients, 5 of whom developed pancreatitis. There were no perforations, no major bleeding and no severe pancreatitis in the NKS group. Conclusions: Patients who undergo NKS have a greater risk of PEP, however NKS is not an independent predictor of PEP. The number of attempts at the papilla is independently associated with PEP and the risk increases with increasing number of attempts. This suggests that papillary trauma is a significant contributor to the increased risk of PEP with NKS in difficult biliary cannulation. The earlier use of needle knife sphincterotomy in difficult biliary cannulation may reduce PEP.
Background and Aims: Benign biliary strictures secondary to chronic pancreatitis (CP) are traditionally managed by ERCP with plastic stents insertion. Their potential to occlude and migrate makes them only temporarily efficacious and has led many to consider other options. Temporary placement of CSEMS might offer an alternative in terms of reducing the number of sessions required, but the higher cost associated of CSEMS may be a concern. This study prospectively compared a group of patients treated by CSEMS to a group of patients who received plastic stents and performed a cost analysis to evaluate the overall cost of each modality. Methods: 22 patients with biliary strictures related to CP underwent CSEMS placement (Wallstent, Boston Scientific), and were compared to a set of 27 patients who received plastic stents with 22 of them matched to the CSEMS group by age (51 12 y/o and 52 13 respectively, p Z 0.67) gender (20 and 17 male in each group, p Z 0.227) and etiology of chronic pancreatitis (15 and 16 alcohol related in each group, p Z 0.748). CSEMS were left in place until adequate biliary drainage was achieved, confirmed by clinical improvement, normalization of liver function tests and imaging before removal was effected with snare or rat tooth . Plastic stents were replaced every three months until resolution of stricture. All procedures were performed by 2 dedicated pancreatico-biliary endoscopists (PY and MK). Response to therapy, morbidity, and overall outcome were determined. A cost analysis was performed using decision analysis software (Treeage Data 3.5). Results: 19 patients in the CSEMS group (86%) responded to treatment versus 18 (82%) in the plastic stent group. CSEMS and plastic stents were left in place for a median time of 5 (range: 1-21) versus 8 months (range: 3-35). Median number of session required until resolution of stricture was respectively 2 (range: 1-3) versus 5 (range: 2-12) (p Z 0.0001). Complications in the CSEMS group included migration without stricture resolution (1), post sphincterotomy bleed (1), pain (1) and worsening pancreatitis with infected pseudocyst (1). One patient spontaneously passed CSEMS with resolution of the stricture. In this model, the total cost using plastic stents was $17,304.92 per patient. Total cost for CSEMS was $10,137.22. The total cost savings using CSEMS was $7,167.70 per patient. Conclusion: The use of CSEMS in benign biliary strictures related to CP provides substantial cost savings compared to conventional ERCP with plastic stenting. The fewer number of sessions required to achieve resolution of stricture using CSEMS compensates for the initial higher cost of CSEMS placement.
www.giejournal.org
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB211
M1263 Methylene Blue Aided Cholangioscopy in Patients with Biliary Strictures-A Novel Method to Detect GI Malignancies Arthur Hoffman, Ralf Kiesslich, Peter R. Galle, Markus Neurath Introduction: Cholangioscopy (CA) in patients with biliary strictures possible increases the diagnostic yield of neoplastic changes. Chromoendoscopy with methylene blue is mainly used in the lower GI tract to delineate neoplastic lesions. Thus, aim of the current study was to perform methylene blue aided cholangioscopy for early detection of biliary neoplasia or specific diagnosis of biliary strictures. Methods: Consecutive patients with newly suspected biliary lesions (ultrasonography or MRI), long standing primary sclerosing cholangitis (PSC) or after orthotopic liver transplantation (OLT) with newly developed biliary strictures were scheduled for ERCP with subsequent cholangioscopy (Pentax FCP-9P). After initial inspection of all reachable biliary segments with CA chromoendoscopy with 15 ml methylene blue (0.1%) was performed via working channel of the cholangioscope. Access dye was removed by suction after 3 minutes waiting time. Newly appearing circumscribed or unstained lesions were noted, recorded and judged according to their macroscopic type and staining features. Methylene blue aided diagnosis was compared with directed biopsies or surgery. Results:A total of 53 patients [biliary stenosis or cholestasis of unknown origin (n Z 23), stenosis after OLT (n Z 23), PSC (n Z 7)] were included. Methylene blue aided cholangioscopy unmasked 48 lesions in 33 patients. Diffuse staining pattern were seen in chronic inflammation (n Z 14 patients) and ischemic type biliary lesions (n Z 19 patients). Unstained or weak stained circumscribed lesions were identified in 4 patients. Final histology confirmed neoplasia (n Z 3 bile duct cancer, n Z 1 hepatocellular carcinoma) in all cases. CA revealed no severe side effects. However, some patients developed a transient discoloration of the urine. Conclusion: Methylene blue aided cholangioscopy is a feasible and safe tool improving the diagnostic yield of biliary strictures. Methylene blue negative staining in circumscribed lesions is a sensitive marker for the presence of neoplastic changes whereas a diffuse staining pattern predicts chronic inflammation. This novel method may be an ideal tool for early detection and diagnosis of biliary malignancies.
M1265 Synergistic Sedation with Oral Midazolam As a Premedication and Intravenous Propofol Titrated to Deep Sedation Versus Intravenous Propofol Titrated to Deep Sedation in ERCP. A Prospective, Randomized Study Maria Manolaraki, Emmanouil Vardas, Angeliki Theodoropoulou, Kostantinos Psaras, Emmanouil Manolakakis, Gregorios Chlouverakis, Gregorios Paspatis Background and Aims: Disadvantages of propofol are lack of a reversal agent and the ability to induce rapid respiratory depression. In contrast to other sedatives propofol has a very narrow therapeutic window. Synergistic sedation with low doses of intravenous (IV) midazolam and propofol reduces significantly the required dose of propofol and therefore the risk of complications. The primary objective of the present study was to compare the required dose of IV propofol between Group A (synergistic sedation with an oral dose of midazolam as premedication combined with IV propofol) and Group B (IV propofol alone) in ERCP. The secondary objective was to compare the patients’ anxiety level before the procedure, the patients’ satisfaction, the recovery times as well as other end points. To the best of our knowledge, this is the only prospective, randomized, comparative study on this subject. Methods: 70 consecutive patients undergoing ERCP were randomly assigned to 1 of the 2 medication regimens. Patients in group A (n Z 37, 14 men, 23 women, mean age 74 yr) received 7.5 mg of midazolam orally and 30 min later IV propofol was given titrated to deep sedation. Patients in group B (n Z 33, 9 men, 24 women, mean age 69 yr) received only IV propofol titrated to deep sedation. Results: Patients receiving propofol alone required higher doses of propofol compared with synergistic sedation (495 243 mg versus 348 248 mg, respectively, p Z 0.01). Patients’ anxiety before the procedure was higher in group B patients compared to those of group A (p ! 0.05). There were no significant differences in vital signs, oxygen saturations, end tidal CO2 or recovery times between the two groups. Patients’ satisfaction was higher in group A patients compared to those of group B, however, the results did not reach a statistically significant level. Multivariate stepwise regression analysis revealed that among sex, age, duration of the procedure, ASA grade and the type of sedation, the type of sedation, the age and the duration of the procedure were the factors significantly associated with the required dose of intravenous propofol. Conclusions: Our data suggest that the synergistic sedation with an oral dose of midazolam combined with IV propofol may provide a significant benefit with regards to a required lower dose of propofol used and the patients’ anxiety before the procedure in ERCP.
M1264 A Prospective Evaluation of Post ERCP Pancreatitis and Precut Needle Knife Sphincterotomy in Difficult Biliary Cannulation Adam A. Bailey, Arthur Kaffes, Stephen J. Williams, Eric Lee, Michael J. Bourke
M1266 Cost Analysis of Temporarily Placed Covered Self Expandable Metallic Stents Versus Plastic Stents in Biliary Strictures Related to Chronic Pancreatitis Brian W. Behm, Andrew Brock, Bridger W. Clarke, Reid B. Adams, Patrick G. Northup, Paul Yeaton, Michel Kahaleh
Background: In the absence of precut needle knife sphincterotomy (NKS), failure of biliary cannulation occurs in approximately 10% of cases. There are few prospective evaluations of the safety and efficacy of NKS and studies of its early use in difficult cannulation have been inconclusive. Whether pre-cut needle knife sphincterotomy after failure of primary biliary cannulation is independently associated with PEP remains controversial. Aim: The aim of this study was to examine the relationship between needle knife sphincterotomy and PEP. Methods: 736 patients with an intact papilla were enrolled in successive, prospective randomized studies that failed to show a reduction in PEP. (1. Glyceryl trinitrate versus placebo and 2. primary guidewire versus contrast cannulation). Patients with pancreatic or ampullary cancer were excluded as PEP is infrequent in this subgroup. The fellow commenced the majority of cases. If unsuccessful after a maximum of 10 minutes, the consultant then attempted for a further maximum of 10 min prior to NKS for failed initial cannulation. Pancreatic stenting prior to NKS was performed at discretion to facilitate biliary localization and protect the pancreatic orifice. Cannulation parameters were recorded prospectively and 24h and 30 day complication rates were assessed by phone interview and 24h serum amylase and lipase level. Results: NKS was performed in 94 of 734 patients (12.8%) and was successful in achieving bile duct access in 80/94 (85%). Cannulation success in the entire group was 717/734 (97.7%). The overall frequency of pancreatitis following needle knife sphincterotomy was 14.9% (14/94) compared to 6.5% without (p ! 0.001). Pancreatitis increased with increasing number of attempts at the papilla. In multivariate analysis, independent predictors of PEP were: female gender (OR Z 3.5, p Z 0.028), suspected SOD (OR Z 9.7, p ! 0.001), partial pancreatic drainage (OR Z 4.8, p Z 0.011), 10 to 14 attempts at papilla (OR Z 4.4, p Z 0.031) and R 15 attempts at papilla (OR Z 9.4, p Z 0.013). Pancreatic stents were inserted in 22 patients, 5 of whom developed pancreatitis. There were no perforations, no major bleeding and no severe pancreatitis in the NKS group. Conclusions: Patients who undergo NKS have a greater risk of PEP, however NKS is not an independent predictor of PEP. The number of attempts at the papilla is independently associated with PEP and the risk increases with increasing number of attempts. This suggests that papillary trauma is a significant contributor to the increased risk of PEP with NKS in difficult biliary cannulation. The earlier use of needle knife sphincterotomy in difficult biliary cannulation may reduce PEP.
Background and Aims: Benign biliary strictures secondary to chronic pancreatitis (CP) are traditionally managed by ERCP with plastic stents insertion. Their potential to occlude and migrate makes them only temporarily efficacious and has led many to consider other options. Temporary placement of CSEMS might offer an alternative in terms of reducing the number of sessions required, but the higher cost associated of CSEMS may be a concern. This study prospectively compared a group of patients treated by CSEMS to a group of patients who received plastic stents and performed a cost analysis to evaluate the overall cost of each modality. Methods: 22 patients with biliary strictures related to CP underwent CSEMS placement (Wallstent, Boston Scientific), and were compared to a set of 27 patients who received plastic stents with 22 of them matched to the CSEMS group by age (51 12 y/o and 52 13 respectively, p Z 0.67) gender (20 and 17 male in each group, p Z 0.227) and etiology of chronic pancreatitis (15 and 16 alcohol related in each group, p Z 0.748). CSEMS were left in place until adequate biliary drainage was achieved, confirmed by clinical improvement, normalization of liver function tests and imaging before removal was effected with snare or rat tooth . Plastic stents were replaced every three months until resolution of stricture. All procedures were performed by 2 dedicated pancreatico-biliary endoscopists (PY and MK). Response to therapy, morbidity, and overall outcome were determined. A cost analysis was performed using decision analysis software (Treeage Data 3.5). Results: 19 patients in the CSEMS group (86%) responded to treatment versus 18 (82%) in the plastic stent group. CSEMS and plastic stents were left in place for a median time of 5 (range: 1-21) versus 8 months (range: 3-35). Median number of session required until resolution of stricture was respectively 2 (range: 1-3) versus 5 (range: 2-12) (p Z 0.0001). Complications in the CSEMS group included migration without stricture resolution (1), post sphincterotomy bleed (1), pain (1) and worsening pancreatitis with infected pseudocyst (1). One patient spontaneously passed CSEMS with resolution of the stricture. In this model, the total cost using plastic stents was $17,304.92 per patient. Total cost for CSEMS was $10,137.22. The total cost savings using CSEMS was $7,167.70 per patient. Conclusion: The use of CSEMS in benign biliary strictures related to CP provides substantial cost savings compared to conventional ERCP with plastic stenting. The fewer number of sessions required to achieve resolution of stricture using CSEMS compensates for the initial higher cost of CSEMS placement.
www.giejournal.org
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB211