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Pancreatic Stent-Induced Ductal Injury: Clinical Presentation and Outcomes of Endoscopic Therapy
Abstracts
acute pancreatitis (AP) following therapy, 2) # of ER visits or hospitalizations, 3) procedure related complications (AP, bleeding, stent related changes). Results: Thirty pts received a total of 93 stents (3.01 per pt). Size of stents included 7Fr (nZ62), 5Fr (nZ30), 10Fr (nZ1). Twelve of 30 pts underwent endoscopic sphincterotomy; this included Biliary ES (nZ4), pancreatic ES (nZ4) & dual ES (nZ4). Sphincterotomy was performed after stent therapy in 7pts & before stent therapy in 5 pts. Follow-up was a mean of 8.86 yrs (range 3-19yrs) & was available in only 22 of 30 pts. 11/22 (50%) pts had complete resolution of AP episodes. 8/22 (36%) had improved outcome (R50% reduction AP) while 3/22 (13%) had no improvement or worsening symptoms. Complications included post procedure pancreatitis 8/93 (8.5%). No stent induced changes were seen in any of our pts. 20 of 93 stents had distally migrated stents while 21 other stents were occluded at the time of removal. Conclusions: Pancreatic stent therapy in pts with IRP results in complete resolution or improvement in episodes of AP in the vast majority of pts. The addition of ES may further benefit outcomes. Randomized, controlled studies comparing stent alone vs. ES alone vs. combined therapy will reveal the most successful endoscopic treatment option.
Outcome
PT (n)
% Total
No AP following Stents Rx Improved (R50%) Worse/No Change AP
11 8 3 22
50% 36% 14% 100%
796 Pancreatic Stent-Induced Ductal Injury: Clinical Presentation and Outcomes of Endoscopic Therapy Yan Bakman, Martin L. Freeman Background: Pancreatic duct (PD) stent placement is increasingly performed for prevention of post-ERCP pancreatitis in patients at high risk. PD stents can result in injury especially in normal ducts, but the clinical significance and outcomes of subsequent endoscopic therapy are not known. Methods: Patients included all those referred from outside facilities to a single pancreaticobiliary center for management of stent-induced PD injury over 3 years. All pts had initially normal PD diameter without evidence of chronic pancreatitis, and all PD stents were placed for prevention of post-ERCP pancreatitis. Results: 8 pts were referred for symptomatic PD stent-induced duct injury. At initial outside ERCP, all had small caliber (! or Z 3 mm) PD with normal PD anatomy (nZ5) or pancreas divisum (nZ3). Indication for initial ERCP with prophylactic PD stent placement was suspected SOD with empirical biliary þ/- pancreatic sphincterotomy without SO manometry (nZ5), or minor papillotomy for pancreas divisum with acute recurrent pancreatitis (nZ1) or marginally elevated lipase (nZ2). All had conventional polyethylene 5F (nZ6) or 7F (nZ2) stents !4 cm in length in place for !2 weeks, except one pt who was lost to follow up with stent in place for one year. At presentation at a mean interval of 18 months after 1st ERCP, all pts had recurrent abdominal pain requiring hospitalization; of these 5/7 (71%) had acute recurrent pancreatitis, and 3/8 (38%) were on daily narcotics. By secretin MRCP/EUS/ERCP, all had a PD stricture within 2cm of major or minor papilla and 5/8 (63 %) upstream PD dilation (mean 4.3 mm, [2.2 mm-8.2 mm]). 3/6 (50%) pts undergoing EUS had new parenchymal changes suggestive of chronic pancreatitis. All patients were treated with pancreatic sphincterotomy (if not done already), balloon dilation of stricture, and placement of multiple 3-5 F soft polymer pancreatic stents depending on duct diameter; Six required multiple (2-11) ERCPs for therapy. All had improvement or resolution of pancreatic strictures and recurrent pancreatitis. 50% had sustained clinical response with resolution of pain, 13% fair response with repeated ERCPs, and 25% with poor response underwent total pancreatectomy with islet autotransplantat. Conclusions: PD stent-induced ductal injury with significant clinical consequences can occur after a relatively brief interval of stenting using conventional polyethylene 5F stents. Endoscopic therapy is moderately effective but some patients develop irreversible damage. Further investigation is required to determine prevalence and risk factors for stent-induced injury and to improve configuration and material of stents.
Randomization was by variable block size. CO2 insufflation was regulated by the Olympus Endoscopic CO2 Regulation Unit (Olympus Medical). Patients, endoscopists, nurses, and data analysts were blinded as to allocation. A nurse not involved with the procedure or data collection set-up and masked the equipment. Conscious sedation with midazolam and fentanyl was used. Primary outcomes were abdominal pain assessed on a 100mm visual analogue scale pre- and 1, 3, 6, and 24 hrs post-ERCP, and abdominal girth (cm) pre- and post-ERCP. Key secondary outcomes were pCO2 levels (mm Hg) measured with transcutaneous capnography and procedural complications. Outcomes were compared using t-tests and chi-square. This is a planned interim analysis. Results: Baseline demographic characteristics, indications for ERCP, and comorbidities were similar in the air (nZ26) and CO2 (nZ24) groups, though cannulation time, procedure time, and procedure failure rate were all higher in the CO2 group. Mean pain scores in the air and CO2 groups were 11 and 12 at baseline (pZ0.89), 8 and 18 at 1 hr (pZ0.08), 12 and 23 at 3 hr (pZ0.12), 13 and 20 at 6 hr (pZ0.41), and 14 and 17 at 24 hr (pZ0.66). Abdominal girth increased a mean of 0.8 cm in the air group and 0.3 cm in the CO2 group (pZ0.73). Baseline pCO2 levels were 41 in the air group and 40 in the CO2 group (pZ0.68), and increased to a mean of 50 in the air group and 48 in the CO2 group (pZ0.57). One patient in the air group and none in the CO2 group had respiratory depression. There were no differences in other complications. Conclusions: The use of CO2 for insufflation during ERCP was safe in a tertiary care referral population. While there was a mild rise in pCO2 in both groups, this was not associated with respiratory complications. Despite procedures being more difficult in the CO2 group, there was no difference between the air and CO2 groups in pain scores or abdominal distention. Patient accrual is ongoing for this study.
798 Enhanced Harmonic Endoscopic Ultrasonography for Assessment of Pancreaticobiliary Malignancies Kazuki Sumiyama, Hiroo Imazu, Hisao Tajiri Background: Endoscopic ultrasonography (EUS) is well established as the most sensitive imaging modality in the detection, differentiation and T-staging of pancreaticobiliary (PB) malignancies. Recently, Sonazoid, a second generation microbubble contrast agent for acoustic imaging, was developed to improve visualization of hepatic lesions for abdominal ultrasonography. This novel contrast agent is visualized with the resonance of gas bubbles at lower acoustic power relative to first generation contrast agents. It is therefore hypothesized that Sonazoid may be well suited for EUS. Aim: To evaluate if the use of Sonazoid can improve EUS assessment of PB cancers in a blinded design. Method: The study protocol was approved by the institutional review board of Jikei University School of Medicine. Patients referred for EUS to evaluate suspected pancreatic and extrahepatic biliary malignancies from October 2007 to October 2008 at Jikei University hospital were enrolled in this study, and all patients provided written informed consent. First, standard screening of the PB system with harmonic imaging (H-EUS) was performed. Enhanced harmonic (EH) EUS was subsequently performed after intravenous infusion of 0.015 mL/kg of Sonazoid. Ultrasound data from H-EUS and EH-EUS were digitally recorded, and the unedited videos were reviewed by a blinded interpreter for assessment of tumor detection and T-staging. A definite diagnosis was made of either EUS-guided fine-needle aspiration or surgical pathology in tumor detection, and surgical pathology in T-staging. Results: Sixty patients underwent EUS evaluation for suspected PB malignancies. Sensitivity and specificity of tumor detection were 92.5% and 90%, respectively, with H-EUS, and 100% and 95%, respectively, with EH-EUS (not significant). In 25 of 60 patients, surgical excision of the primary tumor was successful and eligible for T-stage assessment. Overall accuracy of H-EUS and EH-EUS for T-staging was 70% and 91.7%, respectively (p!0.05). There was discrepancy between H-EUS and EH-EUS for T-staging in six cases. In each of these cases, use of the contrast indicated misdiagnosis with H-EUS (2/10 pancreatic cancers, 1/7 gallbladder cancers, 2/4 bile duct cancers and 1/4 ampullary cancers). Imaging contrast between the anatomic tissue layers such as the mucosa, submucosa and vessel walls was more distinct with EH-EUS. Conclusion: This is the first report to use the second generation ultrasound contrast with EUS staging for PB malignancies in a blinded design. Use of the contrast may improve the accuracy of EUS staging further.
797 A Randomized, Controlled, Double-Blind Trial of Air vs Carbon Dioxide Insufflation During ERCP Evan S. Dellon, Arumugam Velayudham, Bridger W. Clarke, Kim L. Isaacs, Lisa M. Gangarosa, Joseph Galanko, Ian S. Grimm
799 EUS-Guided Ethanol Lavage with Paclitaxel Injection (EUS-EP) for Cystic Tumors of the Pancreas (CTP): Long-Term (More Than One Year) Follow-Up Hyoung-Chul OH, Dong Wan Seo, Tae Jun Song, Sung-Hoon Moon, Do Hyun Park, Sang Soo Lee, Sung Koo Lee, Myung-Hwan Kim
Background: Insufflation of carbon dioxide (CO2) has been shown to decrease patient pain and bloating after colonoscopy, but has not been as extensively studied for use during ERCP. Aim: To assess the safety (transcutaneously measured pCO2; respiratory complications) and efficacy (post-procedural abdominal pain and distention) of CO2 insufflation during ERCP. Methods: We performed a randomized, controlled, doubleblind trial of air vs CO2 insufflation for patients undergoing ERCP at University of North Carolina. Exclusion criteria were age !18, COPD requiring oxygen, known CO2 retention, same-day second endoscopy, use of chronic opiates for pain, and pregnancy.
Background: EUS-guided intervention has been recently tried for the treatment of CTP. Preliminary reports showed the safety and feasibility of EUS-guided intervention. Treatment responses were also somewhat promising, but differed among studies as previous studies involved small number of patients and shortterm follow-up. Its effectiveness, therefore, should be evaluated by the study with larger population and longer follow-up. The present study analyzed the treatment response of EUS-EP over longer period among larger study population, and factors which may influence the treatment response. Methods: Thirty-three patients were
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Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB125
acute pancreatitis (AP) following therapy, 2) # of ER visits or hospitalizations, 3) procedure related complications (AP, bleeding, stent related changes). Results: Thirty pts received a total of 93 stents (3.01 per pt). Size of stents included 7Fr (nZ62), 5Fr (nZ30), 10Fr (nZ1). Twelve of 30 pts underwent endoscopic sphincterotomy; this included Biliary ES (nZ4), pancreatic ES (nZ4) & dual ES (nZ4). Sphincterotomy was performed after stent therapy in 7pts & before stent therapy in 5 pts. Follow-up was a mean of 8.86 yrs (range 3-19yrs) & was available in only 22 of 30 pts. 11/22 (50%) pts had complete resolution of AP episodes. 8/22 (36%) had improved outcome (R50% reduction AP) while 3/22 (13%) had no improvement or worsening symptoms. Complications included post procedure pancreatitis 8/93 (8.5%). No stent induced changes were seen in any of our pts. 20 of 93 stents had distally migrated stents while 21 other stents were occluded at the time of removal. Conclusions: Pancreatic stent therapy in pts with IRP results in complete resolution or improvement in episodes of AP in the vast majority of pts. The addition of ES may further benefit outcomes. Randomized, controlled studies comparing stent alone vs. ES alone vs. combined therapy will reveal the most successful endoscopic treatment option.
Outcome
PT (n)
% Total
No AP following Stents Rx Improved (R50%) Worse/No Change AP
11 8 3 22
50% 36% 14% 100%
796 Pancreatic Stent-Induced Ductal Injury: Clinical Presentation and Outcomes of Endoscopic Therapy Yan Bakman, Martin L. Freeman Background: Pancreatic duct (PD) stent placement is increasingly performed for prevention of post-ERCP pancreatitis in patients at high risk. PD stents can result in injury especially in normal ducts, but the clinical significance and outcomes of subsequent endoscopic therapy are not known. Methods: Patients included all those referred from outside facilities to a single pancreaticobiliary center for management of stent-induced PD injury over 3 years. All pts had initially normal PD diameter without evidence of chronic pancreatitis, and all PD stents were placed for prevention of post-ERCP pancreatitis. Results: 8 pts were referred for symptomatic PD stent-induced duct injury. At initial outside ERCP, all had small caliber (! or Z 3 mm) PD with normal PD anatomy (nZ5) or pancreas divisum (nZ3). Indication for initial ERCP with prophylactic PD stent placement was suspected SOD with empirical biliary þ/- pancreatic sphincterotomy without SO manometry (nZ5), or minor papillotomy for pancreas divisum with acute recurrent pancreatitis (nZ1) or marginally elevated lipase (nZ2). All had conventional polyethylene 5F (nZ6) or 7F (nZ2) stents !4 cm in length in place for !2 weeks, except one pt who was lost to follow up with stent in place for one year. At presentation at a mean interval of 18 months after 1st ERCP, all pts had recurrent abdominal pain requiring hospitalization; of these 5/7 (71%) had acute recurrent pancreatitis, and 3/8 (38%) were on daily narcotics. By secretin MRCP/EUS/ERCP, all had a PD stricture within 2cm of major or minor papilla and 5/8 (63 %) upstream PD dilation (mean 4.3 mm, [2.2 mm-8.2 mm]). 3/6 (50%) pts undergoing EUS had new parenchymal changes suggestive of chronic pancreatitis. All patients were treated with pancreatic sphincterotomy (if not done already), balloon dilation of stricture, and placement of multiple 3-5 F soft polymer pancreatic stents depending on duct diameter; Six required multiple (2-11) ERCPs for therapy. All had improvement or resolution of pancreatic strictures and recurrent pancreatitis. 50% had sustained clinical response with resolution of pain, 13% fair response with repeated ERCPs, and 25% with poor response underwent total pancreatectomy with islet autotransplantat. Conclusions: PD stent-induced ductal injury with significant clinical consequences can occur after a relatively brief interval of stenting using conventional polyethylene 5F stents. Endoscopic therapy is moderately effective but some patients develop irreversible damage. Further investigation is required to determine prevalence and risk factors for stent-induced injury and to improve configuration and material of stents.
Randomization was by variable block size. CO2 insufflation was regulated by the Olympus Endoscopic CO2 Regulation Unit (Olympus Medical). Patients, endoscopists, nurses, and data analysts were blinded as to allocation. A nurse not involved with the procedure or data collection set-up and masked the equipment. Conscious sedation with midazolam and fentanyl was used. Primary outcomes were abdominal pain assessed on a 100mm visual analogue scale pre- and 1, 3, 6, and 24 hrs post-ERCP, and abdominal girth (cm) pre- and post-ERCP. Key secondary outcomes were pCO2 levels (mm Hg) measured with transcutaneous capnography and procedural complications. Outcomes were compared using t-tests and chi-square. This is a planned interim analysis. Results: Baseline demographic characteristics, indications for ERCP, and comorbidities were similar in the air (nZ26) and CO2 (nZ24) groups, though cannulation time, procedure time, and procedure failure rate were all higher in the CO2 group. Mean pain scores in the air and CO2 groups were 11 and 12 at baseline (pZ0.89), 8 and 18 at 1 hr (pZ0.08), 12 and 23 at 3 hr (pZ0.12), 13 and 20 at 6 hr (pZ0.41), and 14 and 17 at 24 hr (pZ0.66). Abdominal girth increased a mean of 0.8 cm in the air group and 0.3 cm in the CO2 group (pZ0.73). Baseline pCO2 levels were 41 in the air group and 40 in the CO2 group (pZ0.68), and increased to a mean of 50 in the air group and 48 in the CO2 group (pZ0.57). One patient in the air group and none in the CO2 group had respiratory depression. There were no differences in other complications. Conclusions: The use of CO2 for insufflation during ERCP was safe in a tertiary care referral population. While there was a mild rise in pCO2 in both groups, this was not associated with respiratory complications. Despite procedures being more difficult in the CO2 group, there was no difference between the air and CO2 groups in pain scores or abdominal distention. Patient accrual is ongoing for this study.
798 Enhanced Harmonic Endoscopic Ultrasonography for Assessment of Pancreaticobiliary Malignancies Kazuki Sumiyama, Hiroo Imazu, Hisao Tajiri Background: Endoscopic ultrasonography (EUS) is well established as the most sensitive imaging modality in the detection, differentiation and T-staging of pancreaticobiliary (PB) malignancies. Recently, Sonazoid, a second generation microbubble contrast agent for acoustic imaging, was developed to improve visualization of hepatic lesions for abdominal ultrasonography. This novel contrast agent is visualized with the resonance of gas bubbles at lower acoustic power relative to first generation contrast agents. It is therefore hypothesized that Sonazoid may be well suited for EUS. Aim: To evaluate if the use of Sonazoid can improve EUS assessment of PB cancers in a blinded design. Method: The study protocol was approved by the institutional review board of Jikei University School of Medicine. Patients referred for EUS to evaluate suspected pancreatic and extrahepatic biliary malignancies from October 2007 to October 2008 at Jikei University hospital were enrolled in this study, and all patients provided written informed consent. First, standard screening of the PB system with harmonic imaging (H-EUS) was performed. Enhanced harmonic (EH) EUS was subsequently performed after intravenous infusion of 0.015 mL/kg of Sonazoid. Ultrasound data from H-EUS and EH-EUS were digitally recorded, and the unedited videos were reviewed by a blinded interpreter for assessment of tumor detection and T-staging. A definite diagnosis was made of either EUS-guided fine-needle aspiration or surgical pathology in tumor detection, and surgical pathology in T-staging. Results: Sixty patients underwent EUS evaluation for suspected PB malignancies. Sensitivity and specificity of tumor detection were 92.5% and 90%, respectively, with H-EUS, and 100% and 95%, respectively, with EH-EUS (not significant). In 25 of 60 patients, surgical excision of the primary tumor was successful and eligible for T-stage assessment. Overall accuracy of H-EUS and EH-EUS for T-staging was 70% and 91.7%, respectively (p!0.05). There was discrepancy between H-EUS and EH-EUS for T-staging in six cases. In each of these cases, use of the contrast indicated misdiagnosis with H-EUS (2/10 pancreatic cancers, 1/7 gallbladder cancers, 2/4 bile duct cancers and 1/4 ampullary cancers). Imaging contrast between the anatomic tissue layers such as the mucosa, submucosa and vessel walls was more distinct with EH-EUS. Conclusion: This is the first report to use the second generation ultrasound contrast with EUS staging for PB malignancies in a blinded design. Use of the contrast may improve the accuracy of EUS staging further.
797 A Randomized, Controlled, Double-Blind Trial of Air vs Carbon Dioxide Insufflation During ERCP Evan S. Dellon, Arumugam Velayudham, Bridger W. Clarke, Kim L. Isaacs, Lisa M. Gangarosa, Joseph Galanko, Ian S. Grimm
799 EUS-Guided Ethanol Lavage with Paclitaxel Injection (EUS-EP) for Cystic Tumors of the Pancreas (CTP): Long-Term (More Than One Year) Follow-Up Hyoung-Chul OH, Dong Wan Seo, Tae Jun Song, Sung-Hoon Moon, Do Hyun Park, Sang Soo Lee, Sung Koo Lee, Myung-Hwan Kim
Background: Insufflation of carbon dioxide (CO2) has been shown to decrease patient pain and bloating after colonoscopy, but has not been as extensively studied for use during ERCP. Aim: To assess the safety (transcutaneously measured pCO2; respiratory complications) and efficacy (post-procedural abdominal pain and distention) of CO2 insufflation during ERCP. Methods: We performed a randomized, controlled, doubleblind trial of air vs CO2 insufflation for patients undergoing ERCP at University of North Carolina. Exclusion criteria were age !18, COPD requiring oxygen, known CO2 retention, same-day second endoscopy, use of chronic opiates for pain, and pregnancy.
Background: EUS-guided intervention has been recently tried for the treatment of CTP. Preliminary reports showed the safety and feasibility of EUS-guided intervention. Treatment responses were also somewhat promising, but differed among studies as previous studies involved small number of patients and shortterm follow-up. Its effectiveness, therefore, should be evaluated by the study with larger population and longer follow-up. The present study analyzed the treatment response of EUS-EP over longer period among larger study population, and factors which may influence the treatment response. Methods: Thirty-three patients were
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Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB125