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Temporary Placement of Fully Covered Self-Expandable Metal Stents (CSEMS) in Benign Biliary Strictures: Preliminary Data
Abstracts Oct 2003 and May 2007, 84 patients (50 males, 66 15 y/o) underwent ERCP with placement of an 8 mm (7) or 10 mm (77) diameter CSEMS (VIABIL , ConMed) for the palliation of distal biliary obstruction: pancreatic (61), ampullary (11), biliary (6), metastatic (5) and duodenal neoplasia (1). Survival, stent patency, complications, and cause of dysfunction were analyzed retrospectively. Results: At the end of the study period, 42 patients were alive, 88% died with a patent stent. 8 CSEMS malfunctioned; 1 migrated distally and 7 occluded secondary to debris (n Z 4), tumor overgrowth (n Z 2) and unclear reasons (n Z 1). CSEMS were left in place and remained patent for a mean of 106 90 days (range: 6-498). Patency at 90, 180 and 360 days were 96, 80 and 53 % respectively (see Figure). Technical difficulty during insertion included 2 proximal stents deployments repositioned endoscopically. Complications (7%) post placement included: post ERCP pancreatitis (2), cholecystitis (2), self limited wire perforation (1) and subcapsular liver hematoma (1). Six patients underwent curative resection. A total of 10 patients had their CSEMS removed uneventfully; 1 received an uncovered metal stent and 9 received a second CSEMS (5 for tissue sampling, 3 for occlusion and 1 for pancreatic drainage). Conclusion: Fully CSEMS have acceptable patency and complication rate. Decreased long term patency appears related mainly to biliary debris. Further long term prospective data is required to confirm this observation.
S1565 Prevention of Cholecystitis in Patients with Distal Neoplasic Biliary Obstruction Treated with Covered Self-Expanding Metal Stents (CSEMS): A Feasibility Study Sonia Gosain, Andrew S. Brock, Anshu Mahajan, Melissa S. Phillips, Henry C. Ho, Kristi Ellen, Vanessa M. Shami, Michel Kahaleh Background: CSEMS have been extensively used by our group for palliation of malignant distal biliary strictures. In certain cases however, their use has been associated with cholecystitis, presumably secondary to occlusion of the cystic duct by the covered stent. Aim: We analyzed the feasibility, efficacy and morbidity of transpapillary gallbladder stent placement in an attempt to prevent cholecystitis in patients who underwent CSEMS placement for obstructive distal biliary neoplasia. Methods: In all patients who presented with malignant obstructive jaundice, a transpapillary CSEMS was deployed, with the proximal end positioned below the cystic insertion whenever possible. In cases where the CSEMS placement required occlusion of the cystic duct, wire access was obtained of both the cystic duct and bile duct. A 7 French single pigtail plastic stent was then inserted into the gallbladder in a transpapillary fashion for decompression, followed by placement of the CSEMS. All patients were followed up prospectively after treatment. Results: A total of 73 patients (50 male, 23 female) aged 65 14 y/o underwent CSEMS placement between Nov 2006 and Oct 2007 and were followed prospectively. In 18 patients, the gallbladder was absent; in 34 the CSEMS was placed below the cystic duct insertion. Out of the 21 patients who had a CSEMS covering the cystic duct insertion, a transpapillary gallbladder stent was attempted in 19 and was successfully placed without complication in 12/19 (63%). The gallbladder was already decompressed in 2/21, therefore gallbladder stenting was not performed. Attempt to access the gallbladder was complicated by wire perforation of the cystic duct in 3 patients; two were treated conservatively, and one required emergent cholecystostomy tube placement. None of the patients who underwent successful gallbladder stent placement developed cholecystitis (see table). Two out of the 10 (20%) patients without transpapillary gallbladder decompression who had a CSEMS covering the cystic duct developed cholecystitis. Conclusion: The ideal placement of CSEMS, when possible, is below the cystic duct insertion. In patients where CSEMS placement may occlude the cystic duct, an attempt at transpapillary stent placement should be considered to minimize the chance of cholecystitis. Characteristics of Patients with Gallbladder in place Number of patients
11
Mean age y/o SD (range) Mean Months follow-up (range) Final outcome
66 9 (49-81) 7 4 (2-12) 4 still alive 1 lost to follow-up 1 underwent Whipple
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S1566 Repeat Metal Stenting May Be Optimal Initial Treatment for Biliary Metal Stent Occlusion in Malignancy Jason N. Rogart, Uzma D. Siddiqui, Priya A. Jamidar, Harry R. Aslanian Background: Palliation of malignant biliary obstruction can be achieved with self-expandable metal stents (SEMS). However, a significant number of SEMS will become occluded and there is little data regarding optimal management. Aims: To review the management and outcomes of patients who presented with and were treated for biliary SEMS occlusion. Methods: A retrospective review of 27 patients with malignant biliary obstruction who presented to Yale-New Haven Hospital with SEMS occlusion was conducted. The study period was from January,1999 through March, 2007. Patency and survival was calculated as the median number of days from initial occlusion to repeat intervention and death, respectively. An incremental cost analysis was performed as described by Detsky and Naglie. Results: A total of 60 ERCPs were performed to treat SEMS occlusions, 57 (95%) of which were successful. Median follow-up was 218 days (range 10-802). 52% of patients required more than one intervention. Placing a second SEMS through the existing SEMS (n Z 14) provided the lowest reocclusion rate (43% vs. 55% for plastic stent and 100% for mechanical balloon cleaning), longest time to reintervention (172 days vs. 66 days for plastic and 43 days for balloon, P ! 0.05), and showed a trend toward longer survival (285 days vs. 188 days for plastic and 194 for balloon, P Z 0.27). Patients who received uncovered SEMS as their first intervention required an average of 0.6 additional ERCPs compared with 0.89 for covered SEMS, 1.27 for plastic, and 1.5 for balloon. There was a trend toward more frequent occlusion with covered SEMS as compared with uncovered SEMS (56% vs. 20%, P Z 0.18). Patients with pancreatic or ampullary cancer (n Z 21) were more likely to re-occlude (67% vs. 0%, P ! 0.01) and required twice as many ERCPs (2.57 vs. 1.0, P ! 0.05). Incremental cost analysis showed that placing uncovered SEMS instead of plastic stent was cost effective if the costs of ERCP exceed $1967, which they do at our institution. Uncovered SEMS and plastic stents were both cost effective compared with mechanical balloon cleaning, with cost effectiveness ratios of $1774 and $1213, respectively. Conclusions: Our findings support the use of uncovered SEMS as an initial intervention in patients with occluded SEMS, as such as strategy provides for longer patency and survival, decreases the number of subsequent ERCPs by 50% compared with plastic stents, and is cost-effective. Further investigation with a randomized, prospective trial comparing plastic stents to both covered and uncovered SEMS should be considered.
S1567 Temporary Placement of Fully Covered Self-Expandable Metal Stents (CSEMS) in Benign Biliary Strictures: Preliminary Data Anshu Mahajan, Henry C. Ho, Andrew S. Brock, Vanessa M. Shami, Kristi Ellen, Timothy M. Schmitt, Michel Kahaleh Background and Aim: Benign biliary strictures (BBS) traditionally have been managed with the placement of multiple plastic stents. Placement of uncovered metal stents has been associated with mucosal hyperplasia, while placement of partially covered self-expandable metal stents has been associated with migration and stricture relapse. Recently, fully CSEMS with anchoring fins became available. We analyzed the efficacy and complication rates of these stents in the treatment of BBS. Materials and Methods: CSEMS (10 mm diameter, Viabil, Conmed) were placed in 33 patients with BBS (25 men, mean aged 56 16 years). Preprocedure diagnoses included chronic pancreatitis (CP) (n Z 19), gallstonerelated strictures (n Z 10), post liver transplant BBS (n Z 3) and autoimmune pancreatitis (n Z 1). CSEMS were left in place until adequate biliary drainage was achieved, confirmed by resolution of symptoms, normalization of LFTs, and imaging. Removal was performed with a snare or rat tooth. Endpoints were efficacy, morbidity and clinical response. Results: Of the 33 patients, CSEMS were removed from 24 (73%). The median time of CSEMS placement was 103 days (range: 62-178). Resolution of the BBS was confirmed in 18/24 patients (75%) after a median post removal follow-up time of 44 days (range: 0-204). All 6 patients failing therapy had biliary strictures secondary to CP; 5 of these patients underwent repeat stenting. Of the 9 patients who did not undergo stent removal, 3 expired from unrelated etiology, 3 had severe pancreatitis preventing repeat procedures, 1 had hepatocarcinoma, 1 underwent stent revision without removal and 1 was lost to follow-up. Technical difficulty during insertion included 2 stent deployments proximal to the distal stricture, repositioned endoscopically. Complications associated with placement (15%) included postERCP pancreatitis (n Z 3, with one severe), post-sphincterotomy bleeding (n Z 1) and pain (n Z 1). Complications associated with removal (13%) included post-ERCP pancreatitis (n Z 2), and pain (n Z 1). One patient had proximal biliary migration diagnosed at removal and one patient had CSEMS duodenal migration with resolution of the stricture. A logistical regression analysis of factors potentially predictive of success (e.g: age, previous stenting, CSEMS length and etiology), showed that BBS secondary to chronic pancreatitis is associated with failure (p value 0.008). Conclusion: Temporary placement of CSEMS for BBS might offer an alternative to plastic stenting. The subset of patients with BBS secondary to CP appears to be refractory to stenting with CSEMS. Comparative long term studies using these stents are needed to confirm sustained success.
Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB167
S1565 Prevention of Cholecystitis in Patients with Distal Neoplasic Biliary Obstruction Treated with Covered Self-Expanding Metal Stents (CSEMS): A Feasibility Study Sonia Gosain, Andrew S. Brock, Anshu Mahajan, Melissa S. Phillips, Henry C. Ho, Kristi Ellen, Vanessa M. Shami, Michel Kahaleh Background: CSEMS have been extensively used by our group for palliation of malignant distal biliary strictures. In certain cases however, their use has been associated with cholecystitis, presumably secondary to occlusion of the cystic duct by the covered stent. Aim: We analyzed the feasibility, efficacy and morbidity of transpapillary gallbladder stent placement in an attempt to prevent cholecystitis in patients who underwent CSEMS placement for obstructive distal biliary neoplasia. Methods: In all patients who presented with malignant obstructive jaundice, a transpapillary CSEMS was deployed, with the proximal end positioned below the cystic insertion whenever possible. In cases where the CSEMS placement required occlusion of the cystic duct, wire access was obtained of both the cystic duct and bile duct. A 7 French single pigtail plastic stent was then inserted into the gallbladder in a transpapillary fashion for decompression, followed by placement of the CSEMS. All patients were followed up prospectively after treatment. Results: A total of 73 patients (50 male, 23 female) aged 65 14 y/o underwent CSEMS placement between Nov 2006 and Oct 2007 and were followed prospectively. In 18 patients, the gallbladder was absent; in 34 the CSEMS was placed below the cystic duct insertion. Out of the 21 patients who had a CSEMS covering the cystic duct insertion, a transpapillary gallbladder stent was attempted in 19 and was successfully placed without complication in 12/19 (63%). The gallbladder was already decompressed in 2/21, therefore gallbladder stenting was not performed. Attempt to access the gallbladder was complicated by wire perforation of the cystic duct in 3 patients; two were treated conservatively, and one required emergent cholecystostomy tube placement. None of the patients who underwent successful gallbladder stent placement developed cholecystitis (see table). Two out of the 10 (20%) patients without transpapillary gallbladder decompression who had a CSEMS covering the cystic duct developed cholecystitis. Conclusion: The ideal placement of CSEMS, when possible, is below the cystic duct insertion. In patients where CSEMS placement may occlude the cystic duct, an attempt at transpapillary stent placement should be considered to minimize the chance of cholecystitis. Characteristics of Patients with Gallbladder in place Number of patients
11
Mean age y/o SD (range) Mean Months follow-up (range) Final outcome
66 9 (49-81) 7 4 (2-12) 4 still alive 1 lost to follow-up 1 underwent Whipple
www.giejournal.org
S1566 Repeat Metal Stenting May Be Optimal Initial Treatment for Biliary Metal Stent Occlusion in Malignancy Jason N. Rogart, Uzma D. Siddiqui, Priya A. Jamidar, Harry R. Aslanian Background: Palliation of malignant biliary obstruction can be achieved with self-expandable metal stents (SEMS). However, a significant number of SEMS will become occluded and there is little data regarding optimal management. Aims: To review the management and outcomes of patients who presented with and were treated for biliary SEMS occlusion. Methods: A retrospective review of 27 patients with malignant biliary obstruction who presented to Yale-New Haven Hospital with SEMS occlusion was conducted. The study period was from January,1999 through March, 2007. Patency and survival was calculated as the median number of days from initial occlusion to repeat intervention and death, respectively. An incremental cost analysis was performed as described by Detsky and Naglie. Results: A total of 60 ERCPs were performed to treat SEMS occlusions, 57 (95%) of which were successful. Median follow-up was 218 days (range 10-802). 52% of patients required more than one intervention. Placing a second SEMS through the existing SEMS (n Z 14) provided the lowest reocclusion rate (43% vs. 55% for plastic stent and 100% for mechanical balloon cleaning), longest time to reintervention (172 days vs. 66 days for plastic and 43 days for balloon, P ! 0.05), and showed a trend toward longer survival (285 days vs. 188 days for plastic and 194 for balloon, P Z 0.27). Patients who received uncovered SEMS as their first intervention required an average of 0.6 additional ERCPs compared with 0.89 for covered SEMS, 1.27 for plastic, and 1.5 for balloon. There was a trend toward more frequent occlusion with covered SEMS as compared with uncovered SEMS (56% vs. 20%, P Z 0.18). Patients with pancreatic or ampullary cancer (n Z 21) were more likely to re-occlude (67% vs. 0%, P ! 0.01) and required twice as many ERCPs (2.57 vs. 1.0, P ! 0.05). Incremental cost analysis showed that placing uncovered SEMS instead of plastic stent was cost effective if the costs of ERCP exceed $1967, which they do at our institution. Uncovered SEMS and plastic stents were both cost effective compared with mechanical balloon cleaning, with cost effectiveness ratios of $1774 and $1213, respectively. Conclusions: Our findings support the use of uncovered SEMS as an initial intervention in patients with occluded SEMS, as such as strategy provides for longer patency and survival, decreases the number of subsequent ERCPs by 50% compared with plastic stents, and is cost-effective. Further investigation with a randomized, prospective trial comparing plastic stents to both covered and uncovered SEMS should be considered.
S1567 Temporary Placement of Fully Covered Self-Expandable Metal Stents (CSEMS) in Benign Biliary Strictures: Preliminary Data Anshu Mahajan, Henry C. Ho, Andrew S. Brock, Vanessa M. Shami, Kristi Ellen, Timothy M. Schmitt, Michel Kahaleh Background and Aim: Benign biliary strictures (BBS) traditionally have been managed with the placement of multiple plastic stents. Placement of uncovered metal stents has been associated with mucosal hyperplasia, while placement of partially covered self-expandable metal stents has been associated with migration and stricture relapse. Recently, fully CSEMS with anchoring fins became available. We analyzed the efficacy and complication rates of these stents in the treatment of BBS. Materials and Methods: CSEMS (10 mm diameter, Viabil, Conmed) were placed in 33 patients with BBS (25 men, mean aged 56 16 years). Preprocedure diagnoses included chronic pancreatitis (CP) (n Z 19), gallstonerelated strictures (n Z 10), post liver transplant BBS (n Z 3) and autoimmune pancreatitis (n Z 1). CSEMS were left in place until adequate biliary drainage was achieved, confirmed by resolution of symptoms, normalization of LFTs, and imaging. Removal was performed with a snare or rat tooth. Endpoints were efficacy, morbidity and clinical response. Results: Of the 33 patients, CSEMS were removed from 24 (73%). The median time of CSEMS placement was 103 days (range: 62-178). Resolution of the BBS was confirmed in 18/24 patients (75%) after a median post removal follow-up time of 44 days (range: 0-204). All 6 patients failing therapy had biliary strictures secondary to CP; 5 of these patients underwent repeat stenting. Of the 9 patients who did not undergo stent removal, 3 expired from unrelated etiology, 3 had severe pancreatitis preventing repeat procedures, 1 had hepatocarcinoma, 1 underwent stent revision without removal and 1 was lost to follow-up. Technical difficulty during insertion included 2 stent deployments proximal to the distal stricture, repositioned endoscopically. Complications associated with placement (15%) included postERCP pancreatitis (n Z 3, with one severe), post-sphincterotomy bleeding (n Z 1) and pain (n Z 1). Complications associated with removal (13%) included post-ERCP pancreatitis (n Z 2), and pain (n Z 1). One patient had proximal biliary migration diagnosed at removal and one patient had CSEMS duodenal migration with resolution of the stricture. A logistical regression analysis of factors potentially predictive of success (e.g: age, previous stenting, CSEMS length and etiology), showed that BBS secondary to chronic pancreatitis is associated with failure (p value 0.008). Conclusion: Temporary placement of CSEMS for BBS might offer an alternative to plastic stenting. The subset of patients with BBS secondary to CP appears to be refractory to stenting with CSEMS. Comparative long term studies using these stents are needed to confirm sustained success.
Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB167