- Email: [email protected]
Su1611 Temperature-Controlled Intraductal Radiofrequency Ablation for Hilar Cholangiocarcinoma: Pilot Feasibility Study
Abstracts
Su1610 Efficacy of Biliary Stenting Using Long Multi-Fenestrated Soft Plastic Stents Compared to Metallic Stents in Unresectable Malignant Hilar Biliary Strictures: a 5-Year Experience From a Tertiary Pancreatico-Biliary Center Tossapol Kerdsirichairat*1, Rajeev Attam2, Mustafa A. Arain2, Brooke Glessing2, Yan Bakman2, Stuart K. Amateau2, Martin L. Freeman2 1 Division of Gastroenterology, University of Michigan, Ann Arbor, MI; 2 Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Minneapolis, MN Background: For endoscopic palliation of unresectable malignant hilar biliary strictures, metallic stents have been shown to have better success at drainage, less number of reinterventions, and possibly improved survival compared with conventional plastic stents. However, prior studies used standard rigid plastic stents which may not be ideal for hilar tumor drainage. We report our experience using JohlinÒ pancreatic wedge stents (soft PellethaneÒ, multifenestrated with large, multi-sideholes, 8.5 Fr and 10 Fr, up to 22 cm length), (MFPS) which have several potential design advantages over conventional plastic stents, including larger sideholes, conformable flexibility and greater length. Methods: We conducted a matched casecontrol study among patients with unresectable malignant hilar biliary obstruction treated between 1/2009-12/2013. We compared 38 patients treated with transpapillary MFPS with a control group of 32 pts treated with 6F delivery system open-cell metallic stents placed above the papilla. Drainage (selection and # of sectors [r anterior, r posterior, left]) was based on MRCP/CT with goal of draining O50% viable liver volume. Outcomes (successful stent insertion and drainage rate, complications, duration of stent patency, and survival) of stents were prospectively recorded. Result: MFPS (Figure 1) were inserted in 38 patients (21 male, 20 cholangiocarcinoma and 18 metastasis [8.5 Fr stent (nZ37) and 10 Fr stents (nZ78) . Median Bismuth class was IV. Successful insertion and drainage occurred after 77/79 (97.5%) MFPS attempts vs 45 (97.8%) of metallic stent attempts. Complications after MFPS were cholangitis (nZ2) and stent migration (nZ1). Complications after metallic stents were bleeding (nZ1). MFPS had significantly shorter duration of patency than metallic stents [41.227.8 Vs 162.5139.5 days (P!0.001)] but there was no significant difference in survival. By multivariate regression, factors associated with longer duration of stents were ageO 60 (p!0.001), higher number of sectors drained (pZ0.004), higher Bismuth classification (pZ0.007), and metallic stents (pZ0.001). Factors associated with longer survival rate were age O60 (pZ0.028), cholangiocarcioma compared to metastatic hilar lesions (p!0.001), and more recent years of procedures (pZ0.028). Bilirubin levels were not predictive of outcomes. Conclusion: Endoscopic biliary drainage with MFPS resulted in safe and effective long term palliation in patients with highly complex unresectable malignant hilar biliary strictures. with shorter patency but similar survival compared to open cell metallic stents. Image-targeted drainage of more than one sector as necessary to drain O50% of liver volume using either type of stent resulted in longest patency for patients with higher Bismuth class (including IV) lesions, generally thought to be unsuitable for endoscopic drainage. Table 1. characteristics and outcomes of patients treated with MFPS
and SEMS Characteristics (pts) Number of stents per session (IQR) Sectoral drainage 1 sectoral duct 2 sectoral ducts
MFPS
SEMS
38 2 (2,3)
32 2 (1,2)
23 14
11 20 (all Y configuration except 1 parallel) 1 (Y configuration) 21/17
0.42
4 (2,4) 7.865.95 2
0.37 0.97 0.99
45/46
0.92
1 162.5139.5
0.24 !0.001
501.7361.9
0.51
3 sectoral ducts 1 Nature of malignancy 20/18 (cholangiocarcinoma vs metastasis) Bismuth (IQR) 4 (2,4) Bilirubin (mg/dL, meanSD) 6.84 Radiofrequency ablation (pts) 2 Outcomes Successful insertion rate 77/79 (procedures) Early complication (procedures) 3 Stent patency (days per 41.227.8 procedure, meanSD) Survival (days from index 375.7345.2 procedure, meanSD)
Su1611 Temperature-Controlled Intraductal Radiofrequency Ablation for Hilar Cholangiocarcinoma: Pilot Feasibility Study Dong Uk Kim*1, Dong Hoon Baek1, Chang Won Kim2, Geun Am Song1 1 Gastroenterology, Pusan National University School of Medicine, Busan, Korea (the Republic of); 2Department of Interventional Radiology, Pusan National University Hospital, Busan, Korea (the Republic of) Background and Aims: Local ablation therapy is considered to preserve ductal patency for longer survival of patients with unresectable hilar cholangiocarcinoma. The ablations of intraductal tumors have recently been simplified by introductions of radiofrequency ablation (RFA) probe. However, the risk of bile duct perforation and hemorrhage is still high because of uncontrolled massive energy delivered to bile duct. We evaluated the feasibility of temperature-controlled intraductal RFA for preserving the ductal patency and reducing the risk of bile duct perforation or hemorrhage for patients with unresectable hilar cholangiocarcinoma. Methods: Ten patients with unresectable hilar cholangiocarcinoma were enrolled. Intraductal biliary RFA was performed by using a newly designed temperature-controlled RFA catheter (ELRAⓇ STARTmed, Seoul, Korea) through endoscopic (6 patients) or percutaneous (4 patients) approach. Each RFA was applied at 10 watts for a time period of 2 minutes under 80 C of intraductal temperature which is provided by a temperature sensor inside of an electrode. We evaluated short-term complications and 90-day biliary patency. Results: Deployment of an RFA catheter was successful in ten patients. Self-expandable metal stents (SEMS) placement was achieved in all cases after successful RFA. Four patients immediately experienced acute cholangitis. One of these patients failed to demonstrate successful biliary decompression and died in 69 days. There were no bile duct perforation, hemorrhage, or pancreatitis as short-term complications. At 90-day follow-up, 2 of 9 patients had occluded biliary stents. Median stent patency was 117 (range 50-208) days. Conclusions: It appears that this novel approach is safe and feasible. For further study, we suggest large scale randomized controlled studies with long-term follow-up.
0.67
AB350 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
Su1612 Safety and Efficacy of a Novel Endobiliary Radiofrequency Ablation Catheter (Elraâ) in a Swine Model Jae Hee Cho*1, Kwang Hyuck Lee2, Joon Mee Kim3, Yoon Jae Kim1, Don Haeng Lee4, Seok Jeong4 1 Department of Internal Medicine, Gachon university, Gil Medical Center, Incheon, Korea (the Republic of); 2Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of); 3Department of Pathology, Inha University School of Medicine, Incheon, Korea (the Republic of); 4 Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea (the Republic of) Background and Aim: Endobiliary radiofrequency ablation(EB-RFA) is a new endoscopic palliation and adjunctive tool. Although EB-RFA has been increasingly performed worldwide, the main concern is the likelihood of an iatrogenic thermal injury leading to perforation or bleeding. Therefore, we aimed to assess the effects of thermal and coagulation injury after in vivo EB-RFA using a novel RFA catheter(ELRAÒ RF catheter, STARmed, Goyang, Korea) Method: Twelve mini-pigs were divided into four groups according to power (10 watts of 33mm elecrode vs. 7 watts of 18mm electrode) and RFA target temperature(75 vs. 80 C). All pigs underwent endoscopic retrograde cholangiography(ERC) and target temperature controlled EBRFA for 120 seconds. Additional cholangiogram was taken immediately after RFA, and all pigs were sacrificed after 24 hours to assess the macroscopic/microscopic RFA injury. Results: The ERC and application of the EB-RFA was successful in 100%, and post-RFA cholangiogram did not show the contrast leakage. Macroscopic
www.giejournal.org
Su1610 Efficacy of Biliary Stenting Using Long Multi-Fenestrated Soft Plastic Stents Compared to Metallic Stents in Unresectable Malignant Hilar Biliary Strictures: a 5-Year Experience From a Tertiary Pancreatico-Biliary Center Tossapol Kerdsirichairat*1, Rajeev Attam2, Mustafa A. Arain2, Brooke Glessing2, Yan Bakman2, Stuart K. Amateau2, Martin L. Freeman2 1 Division of Gastroenterology, University of Michigan, Ann Arbor, MI; 2 Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Minneapolis, MN Background: For endoscopic palliation of unresectable malignant hilar biliary strictures, metallic stents have been shown to have better success at drainage, less number of reinterventions, and possibly improved survival compared with conventional plastic stents. However, prior studies used standard rigid plastic stents which may not be ideal for hilar tumor drainage. We report our experience using JohlinÒ pancreatic wedge stents (soft PellethaneÒ, multifenestrated with large, multi-sideholes, 8.5 Fr and 10 Fr, up to 22 cm length), (MFPS) which have several potential design advantages over conventional plastic stents, including larger sideholes, conformable flexibility and greater length. Methods: We conducted a matched casecontrol study among patients with unresectable malignant hilar biliary obstruction treated between 1/2009-12/2013. We compared 38 patients treated with transpapillary MFPS with a control group of 32 pts treated with 6F delivery system open-cell metallic stents placed above the papilla. Drainage (selection and # of sectors [r anterior, r posterior, left]) was based on MRCP/CT with goal of draining O50% viable liver volume. Outcomes (successful stent insertion and drainage rate, complications, duration of stent patency, and survival) of stents were prospectively recorded. Result: MFPS (Figure 1) were inserted in 38 patients (21 male, 20 cholangiocarcinoma and 18 metastasis [8.5 Fr stent (nZ37) and 10 Fr stents (nZ78) . Median Bismuth class was IV. Successful insertion and drainage occurred after 77/79 (97.5%) MFPS attempts vs 45 (97.8%) of metallic stent attempts. Complications after MFPS were cholangitis (nZ2) and stent migration (nZ1). Complications after metallic stents were bleeding (nZ1). MFPS had significantly shorter duration of patency than metallic stents [41.227.8 Vs 162.5139.5 days (P!0.001)] but there was no significant difference in survival. By multivariate regression, factors associated with longer duration of stents were ageO 60 (p!0.001), higher number of sectors drained (pZ0.004), higher Bismuth classification (pZ0.007), and metallic stents (pZ0.001). Factors associated with longer survival rate were age O60 (pZ0.028), cholangiocarcioma compared to metastatic hilar lesions (p!0.001), and more recent years of procedures (pZ0.028). Bilirubin levels were not predictive of outcomes. Conclusion: Endoscopic biliary drainage with MFPS resulted in safe and effective long term palliation in patients with highly complex unresectable malignant hilar biliary strictures. with shorter patency but similar survival compared to open cell metallic stents. Image-targeted drainage of more than one sector as necessary to drain O50% of liver volume using either type of stent resulted in longest patency for patients with higher Bismuth class (including IV) lesions, generally thought to be unsuitable for endoscopic drainage. Table 1. characteristics and outcomes of patients treated with MFPS
and SEMS Characteristics (pts) Number of stents per session (IQR) Sectoral drainage 1 sectoral duct 2 sectoral ducts
MFPS
SEMS
38 2 (2,3)
32 2 (1,2)
23 14
11 20 (all Y configuration except 1 parallel) 1 (Y configuration) 21/17
0.42
4 (2,4) 7.865.95 2
0.37 0.97 0.99
45/46
0.92
1 162.5139.5
0.24 !0.001
501.7361.9
0.51
3 sectoral ducts 1 Nature of malignancy 20/18 (cholangiocarcinoma vs metastasis) Bismuth (IQR) 4 (2,4) Bilirubin (mg/dL, meanSD) 6.84 Radiofrequency ablation (pts) 2 Outcomes Successful insertion rate 77/79 (procedures) Early complication (procedures) 3 Stent patency (days per 41.227.8 procedure, meanSD) Survival (days from index 375.7345.2 procedure, meanSD)
Su1611 Temperature-Controlled Intraductal Radiofrequency Ablation for Hilar Cholangiocarcinoma: Pilot Feasibility Study Dong Uk Kim*1, Dong Hoon Baek1, Chang Won Kim2, Geun Am Song1 1 Gastroenterology, Pusan National University School of Medicine, Busan, Korea (the Republic of); 2Department of Interventional Radiology, Pusan National University Hospital, Busan, Korea (the Republic of) Background and Aims: Local ablation therapy is considered to preserve ductal patency for longer survival of patients with unresectable hilar cholangiocarcinoma. The ablations of intraductal tumors have recently been simplified by introductions of radiofrequency ablation (RFA) probe. However, the risk of bile duct perforation and hemorrhage is still high because of uncontrolled massive energy delivered to bile duct. We evaluated the feasibility of temperature-controlled intraductal RFA for preserving the ductal patency and reducing the risk of bile duct perforation or hemorrhage for patients with unresectable hilar cholangiocarcinoma. Methods: Ten patients with unresectable hilar cholangiocarcinoma were enrolled. Intraductal biliary RFA was performed by using a newly designed temperature-controlled RFA catheter (ELRAⓇ STARTmed, Seoul, Korea) through endoscopic (6 patients) or percutaneous (4 patients) approach. Each RFA was applied at 10 watts for a time period of 2 minutes under 80 C of intraductal temperature which is provided by a temperature sensor inside of an electrode. We evaluated short-term complications and 90-day biliary patency. Results: Deployment of an RFA catheter was successful in ten patients. Self-expandable metal stents (SEMS) placement was achieved in all cases after successful RFA. Four patients immediately experienced acute cholangitis. One of these patients failed to demonstrate successful biliary decompression and died in 69 days. There were no bile duct perforation, hemorrhage, or pancreatitis as short-term complications. At 90-day follow-up, 2 of 9 patients had occluded biliary stents. Median stent patency was 117 (range 50-208) days. Conclusions: It appears that this novel approach is safe and feasible. For further study, we suggest large scale randomized controlled studies with long-term follow-up.
0.67
AB350 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
Su1612 Safety and Efficacy of a Novel Endobiliary Radiofrequency Ablation Catheter (Elraâ) in a Swine Model Jae Hee Cho*1, Kwang Hyuck Lee2, Joon Mee Kim3, Yoon Jae Kim1, Don Haeng Lee4, Seok Jeong4 1 Department of Internal Medicine, Gachon university, Gil Medical Center, Incheon, Korea (the Republic of); 2Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of); 3Department of Pathology, Inha University School of Medicine, Incheon, Korea (the Republic of); 4 Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea (the Republic of) Background and Aim: Endobiliary radiofrequency ablation(EB-RFA) is a new endoscopic palliation and adjunctive tool. Although EB-RFA has been increasingly performed worldwide, the main concern is the likelihood of an iatrogenic thermal injury leading to perforation or bleeding. Therefore, we aimed to assess the effects of thermal and coagulation injury after in vivo EB-RFA using a novel RFA catheter(ELRAÒ RF catheter, STARmed, Goyang, Korea) Method: Twelve mini-pigs were divided into four groups according to power (10 watts of 33mm elecrode vs. 7 watts of 18mm electrode) and RFA target temperature(75 vs. 80 C). All pigs underwent endoscopic retrograde cholangiography(ERC) and target temperature controlled EBRFA for 120 seconds. Additional cholangiogram was taken immediately after RFA, and all pigs were sacrificed after 24 hours to assess the macroscopic/microscopic RFA injury. Results: The ERC and application of the EB-RFA was successful in 100%, and post-RFA cholangiogram did not show the contrast leakage. Macroscopic
www.giejournal.org