- Email: [email protected]
Duodeno-Biliary Reflux May Contribute to Biliary Stent Occlusion: Prospective Randomized Study of a New Biliary Stent with An Anti-Duodeno-Biliary Reflux Valve in Patients with Biliary Strictures
Abstracts
501 The Treatment of a Benign Biliary Stricture with a Novel, Endoscopically Inserted Biodegradable Biliary Stent Johanna Laukkarinen, Juhani Sand, Joonas Mikkonen, Heidi Gro ¨hn, Isto Nordback
503 Duodeno-Biliary Reflux May Contribute to Biliary Stent Occlusion: Prospective Randomized Study of a New Biliary Stent with An Anti-Duodeno-Biliary Reflux Valve in Patients with Biliary Strictures Kulwinder S. Dua, Jasmohan S. Bajaj, Nageshwar Reddy, G. Rao
Introduction and Aim: Treatment of benign bile duct strictures (BDS) is a challenging clinical problem. Despite the development of various mini-invasive BDS treatment methods, such as percutaneous or endoscopic stenting techniques, the results are far from satisfactory. Drawback of the nonsurgical treatment of the BDS is the need for multiple approaches. An ideal method might be stenting of the stricture with enlarging, self absorbing stent either endoscopically or percutaneously under fluoroscopy. Our aim was to study a one-approach technique with a new, biodegradable biliary stent (BDBS) inserted duodenoscopically in treating the BDS in a large animal model. Methods: Yorkshire pigs with ischemic BDS (n Z 24; model reported in Gastroenterolology 2004;126(suppl2):A-775) either underwent duodenoscopy and ERC (n Z 16), where the braided, selfenlarging BaSO4–PLA BDBS (Group 1; n Z 8) or metallic Wallstent (Group 2; n Z 8) was inserted into the site of the BDS, or had no approach (Group 3; n Z 8), and were followed by repeated 99mTecnetium biligraphy, x-ray and serum determinations until death or sacrificed at 6 months, when the BDS was measured. Results: After confirming the BDS in fluoroscopy, BDBS (Group 1) or metallic stent (Group 2) was successfully inserted in 7/8 animals in both Group 1 and 2. The Group 1 and 2 pigs did not differ in serum liver function tests or in liver clearance 45 min after 99mTc injection during the follow-up time. In the x-ray the stent was seen in all of the Group 2 animals still at 6 months, but in none of the Group 1 animals after 3 months. At 6 months the BD lumen was open in Groups 1 and 2; BDBS had dissolved in all of the Group 1 animals, whereas in Group 2 animals the metallic stent was still in situ. All Group 3 (BDS) animals died for biliary cirrhosis before 6 months. Conclusions: This novel biodegradable biliary stent ensures biliary drainage and seems promising when a benign bile duct stricture is stented endoscopically.
Introduction: The mechanism leading to occlusion of plastic biliary stents is not known. Duodeno-biliary reflux may be a contributory factor as plant material has been found in some of these occluded stents (Zhang et al, Gastroenterol 2003). In a recent study, an anti-reflux valve was attached to a plastic biliary stent and using in vitro techniques, this anti-reflux biliary stent was shown to be effective in preventing retrograde flow without interfering with the primary function of the stent, namely, antegrade flow (Dua et al Gastrointest Endosc 2001). Aims: To evaluate the impact of preventing duodeno-biliary reflux on biliary stent occlusion. Methods: Tannenbaum (10Fr, no side-holes, Wilson-Cook Medical) stents were modified by attaching a 4.5 cm tubular Teflon sheath to their duodenal ends to work like a ‘‘windsock’’ valve (AR-biliary stent). Twenty patients with common bile duct strictures (pancreas cancer 10, cholangiocarcinoma 8, benign strictures 2) were randomized to either a standard 10Fr. Tannenbaum stent or an AR-biliary stent. Age, sex, disease characteristics and length of stents used were similar between the two groups. To prevent reflux around the stent, sphincterotomy was not performed in any patient. All patients were followed up and stent occlusion was determined by clinical monitoring, liver functions and stent evaluation after removal. Results: There were no technical difficulties in placing the AR-biliary stent using techniques similar to standard Tannenbaum stents. Mean duration of patency for the AR-biliary stents was 163 G 13SD days compared to 113 G 10 days for the standard stents (p Z 0.005). There was no stent migration in either group and both stents were equally effective in improving liver function tests. Conclusion: Anti-reflux biliary stents remain patent for a longer time compared to standard stents. This finding suggests that duodeno-biliary reflux may contribute towards stent occlusion.
502 A Novel Endoscopic Approach to Brachytherapy in the Management of Hilar Cholangiocarcinoma Todd H. Baron, Dia T. Simmons, Bret Petersen, Christopher J. Gostout, Michael G. Haddock, Gregory J. Gores, Peter D. Yeakel, Mark D. Topazian, Michael J. Levy
504 Biodegradable Biliary Stent in the Endoscopic Treatment of Cystic Duct Leakage After Cholecystectomy Johanna Laukkarinen, Isto Nordback, Joonas Mikkonen, Juhani Sand
Background: Biliary brachytherapy is usually performed via a percutaneous transhepatic approach. Most endoscopic approaches involve removal of existing biliary stents and placement of a nasobiliary tube (NBT); the radioactive source is then passed through the NBT. Another ERCP is needed for stent replacement. We describe a novel technique for endoscopic insertion of the radiation source through previously placed 10Fr stents. Aims: To review the Mayo Clinic Rochester experience and complications of endoscopically guided brachytherapy (EBT) for hilar cholangiocarcinoma. Methods: Medical records of all Mayo Clinic Rochester patients undergoing EBT without the use of nasobiliary drains were reviewed. Most patients were part of a treatment protocol with curative intent including external beam radiation therapy (4500cGy), chemotherapy, low dose rate brachytherapy (! 3000cGy) with bolus 5FU followed by liver transplantation. The brachytherapy target area was pre-determined using CT simulation. 10Fr biliary stents placed across the malignant biliary stricture were cannulated in freehand fashion using 192Ir embedded wires within a 300 cm long, 5.5Fr plastic sheath (Best industries, Springfield, Va). The wires were positioned fluoroscopically across the known stricture. After withdrawal of the endoscope, the proximal end of the wire was rerouted through the oropharynx out the nares. The patient was hospitalized in a lead-lined room for 24 hours after which the 192Ir wires were removed non-endoscopically. Results: Between 1998 and 2004, 34 patients underwent EBT for hilar cholangiocarcinoma without the use of NBT (mean age Z 50.6 years, 76% male, 79% white, 59% PSC). 10 Fr plastic stents (12 to 15 cm lengths) were used. Unilateral 192Ir wires were placed in 23; bilateral wires were used in 11. Minor complications occurred in 15 patients (44%) and included radiation duodenitis (7), duodenal stricture (1), post procedure pancreatitis (1), early stent migration (2), early stent occlusion (1), pyloric channel or duodenal ulcer (3), and early cholangitis (2) - all managed non-surgically. Conclusions: Endoscopically guided biliary brachytherapy is technically feasible, safe and can be performed without the use of nasobiliary tubes. Stents remain in place to ensure biliary drainage. This unique method avoids the need for percutaneous procedures and may reduce the number of endoscopic procedures as compared to the NBT-guided method.
Introduction: When performing cholecystectomy, cystic duct (CD) is cut and closed by clipsing or ligation. In even up to 1-2% of the patients operated by laparoscopic technique a bile leakage from the remnant of CD is diagnosed postoperatively. In most of the cases, CD leakage can be treated duodenoscopically (ERC) using a plastic biliary stent, which, however, needs to be removed later. Our aim was to study a one-approach technique with a new, biodegradable biliary stent (BDBS) inserted duodenoscopically in treating the CD leakage in a pig. Methods: The braided, self-reinforced, ˜a-sterilised barium sulphate (BaSO4) – polylactide (PLA) BDBSs (length 50 mm, OD 7 mm) were used in this controlled study with 12 Yorkshire pigs (48 G 2.8 kg) Cholecystectomy was performed and cystic artery was ligated. CD was cut 10-20 mm from CBD without ligating. A drain was left into foramen Winslov and connected extra-abdominally into a collection sac. In duodenoscopy papilla of Vater was cannulated and cholangiography was performed. With the assistance of a guide wire, a biodegradable (Group 1) or a 10 fr, 70 mm plastic (Group 2) biliary stent was inserted into the CBD, leaving about 10 mm of the stent outside from the papilla. The volume of bile output in the drain sac was measured daily, and the drain was removed when the output had diminished into 40 ml per day. Cefuroksim antibiotic was given i.v. for 7 days postoperatively. The animals were followed by repeated abdominal x-ray and blood serum determinations for one month. Results: Cholangiography confirmed leakage from CD in all of the animals. A BDBS (Group 1) or a plastic stent (Group 2) was successfully inserted into the BD in 6/6 animals in both groups. During the followup time the pigs did not differ in blood leukocyte counts or serum liver function tests. In Group 1 (BDBS) the total output of bile into the collection drain from the abdominal cavity was smaller and the drains were removed earlier (median 3 vs 6 days after the procedure; p!0.05) compared to the Group 2 (plastic stent) animals. In the x-ray a BDBS (Group 1) or a plastic stent (Group 2) was seen in situ in 5/6 animals in both of the groups at 1 month. Conclusions: A biodegradable biliary stent seems very promising and may work even better compared to the plastic stent in the endoscopic treatment of post cholecystectomy leakage of cystic duct. Furthermore, removal of the stent is avoided.
www.mosby.com/gie
Volume 61, No. 5 : 2005 GASTROINTESTINAL ENDOSCOPY AB97
501 The Treatment of a Benign Biliary Stricture with a Novel, Endoscopically Inserted Biodegradable Biliary Stent Johanna Laukkarinen, Juhani Sand, Joonas Mikkonen, Heidi Gro ¨hn, Isto Nordback
503 Duodeno-Biliary Reflux May Contribute to Biliary Stent Occlusion: Prospective Randomized Study of a New Biliary Stent with An Anti-Duodeno-Biliary Reflux Valve in Patients with Biliary Strictures Kulwinder S. Dua, Jasmohan S. Bajaj, Nageshwar Reddy, G. Rao
Introduction and Aim: Treatment of benign bile duct strictures (BDS) is a challenging clinical problem. Despite the development of various mini-invasive BDS treatment methods, such as percutaneous or endoscopic stenting techniques, the results are far from satisfactory. Drawback of the nonsurgical treatment of the BDS is the need for multiple approaches. An ideal method might be stenting of the stricture with enlarging, self absorbing stent either endoscopically or percutaneously under fluoroscopy. Our aim was to study a one-approach technique with a new, biodegradable biliary stent (BDBS) inserted duodenoscopically in treating the BDS in a large animal model. Methods: Yorkshire pigs with ischemic BDS (n Z 24; model reported in Gastroenterolology 2004;126(suppl2):A-775) either underwent duodenoscopy and ERC (n Z 16), where the braided, selfenlarging BaSO4–PLA BDBS (Group 1; n Z 8) or metallic Wallstent (Group 2; n Z 8) was inserted into the site of the BDS, or had no approach (Group 3; n Z 8), and were followed by repeated 99mTecnetium biligraphy, x-ray and serum determinations until death or sacrificed at 6 months, when the BDS was measured. Results: After confirming the BDS in fluoroscopy, BDBS (Group 1) or metallic stent (Group 2) was successfully inserted in 7/8 animals in both Group 1 and 2. The Group 1 and 2 pigs did not differ in serum liver function tests or in liver clearance 45 min after 99mTc injection during the follow-up time. In the x-ray the stent was seen in all of the Group 2 animals still at 6 months, but in none of the Group 1 animals after 3 months. At 6 months the BD lumen was open in Groups 1 and 2; BDBS had dissolved in all of the Group 1 animals, whereas in Group 2 animals the metallic stent was still in situ. All Group 3 (BDS) animals died for biliary cirrhosis before 6 months. Conclusions: This novel biodegradable biliary stent ensures biliary drainage and seems promising when a benign bile duct stricture is stented endoscopically.
Introduction: The mechanism leading to occlusion of plastic biliary stents is not known. Duodeno-biliary reflux may be a contributory factor as plant material has been found in some of these occluded stents (Zhang et al, Gastroenterol 2003). In a recent study, an anti-reflux valve was attached to a plastic biliary stent and using in vitro techniques, this anti-reflux biliary stent was shown to be effective in preventing retrograde flow without interfering with the primary function of the stent, namely, antegrade flow (Dua et al Gastrointest Endosc 2001). Aims: To evaluate the impact of preventing duodeno-biliary reflux on biliary stent occlusion. Methods: Tannenbaum (10Fr, no side-holes, Wilson-Cook Medical) stents were modified by attaching a 4.5 cm tubular Teflon sheath to their duodenal ends to work like a ‘‘windsock’’ valve (AR-biliary stent). Twenty patients with common bile duct strictures (pancreas cancer 10, cholangiocarcinoma 8, benign strictures 2) were randomized to either a standard 10Fr. Tannenbaum stent or an AR-biliary stent. Age, sex, disease characteristics and length of stents used were similar between the two groups. To prevent reflux around the stent, sphincterotomy was not performed in any patient. All patients were followed up and stent occlusion was determined by clinical monitoring, liver functions and stent evaluation after removal. Results: There were no technical difficulties in placing the AR-biliary stent using techniques similar to standard Tannenbaum stents. Mean duration of patency for the AR-biliary stents was 163 G 13SD days compared to 113 G 10 days for the standard stents (p Z 0.005). There was no stent migration in either group and both stents were equally effective in improving liver function tests. Conclusion: Anti-reflux biliary stents remain patent for a longer time compared to standard stents. This finding suggests that duodeno-biliary reflux may contribute towards stent occlusion.
502 A Novel Endoscopic Approach to Brachytherapy in the Management of Hilar Cholangiocarcinoma Todd H. Baron, Dia T. Simmons, Bret Petersen, Christopher J. Gostout, Michael G. Haddock, Gregory J. Gores, Peter D. Yeakel, Mark D. Topazian, Michael J. Levy
504 Biodegradable Biliary Stent in the Endoscopic Treatment of Cystic Duct Leakage After Cholecystectomy Johanna Laukkarinen, Isto Nordback, Joonas Mikkonen, Juhani Sand
Background: Biliary brachytherapy is usually performed via a percutaneous transhepatic approach. Most endoscopic approaches involve removal of existing biliary stents and placement of a nasobiliary tube (NBT); the radioactive source is then passed through the NBT. Another ERCP is needed for stent replacement. We describe a novel technique for endoscopic insertion of the radiation source through previously placed 10Fr stents. Aims: To review the Mayo Clinic Rochester experience and complications of endoscopically guided brachytherapy (EBT) for hilar cholangiocarcinoma. Methods: Medical records of all Mayo Clinic Rochester patients undergoing EBT without the use of nasobiliary drains were reviewed. Most patients were part of a treatment protocol with curative intent including external beam radiation therapy (4500cGy), chemotherapy, low dose rate brachytherapy (! 3000cGy) with bolus 5FU followed by liver transplantation. The brachytherapy target area was pre-determined using CT simulation. 10Fr biliary stents placed across the malignant biliary stricture were cannulated in freehand fashion using 192Ir embedded wires within a 300 cm long, 5.5Fr plastic sheath (Best industries, Springfield, Va). The wires were positioned fluoroscopically across the known stricture. After withdrawal of the endoscope, the proximal end of the wire was rerouted through the oropharynx out the nares. The patient was hospitalized in a lead-lined room for 24 hours after which the 192Ir wires were removed non-endoscopically. Results: Between 1998 and 2004, 34 patients underwent EBT for hilar cholangiocarcinoma without the use of NBT (mean age Z 50.6 years, 76% male, 79% white, 59% PSC). 10 Fr plastic stents (12 to 15 cm lengths) were used. Unilateral 192Ir wires were placed in 23; bilateral wires were used in 11. Minor complications occurred in 15 patients (44%) and included radiation duodenitis (7), duodenal stricture (1), post procedure pancreatitis (1), early stent migration (2), early stent occlusion (1), pyloric channel or duodenal ulcer (3), and early cholangitis (2) - all managed non-surgically. Conclusions: Endoscopically guided biliary brachytherapy is technically feasible, safe and can be performed without the use of nasobiliary tubes. Stents remain in place to ensure biliary drainage. This unique method avoids the need for percutaneous procedures and may reduce the number of endoscopic procedures as compared to the NBT-guided method.
Introduction: When performing cholecystectomy, cystic duct (CD) is cut and closed by clipsing or ligation. In even up to 1-2% of the patients operated by laparoscopic technique a bile leakage from the remnant of CD is diagnosed postoperatively. In most of the cases, CD leakage can be treated duodenoscopically (ERC) using a plastic biliary stent, which, however, needs to be removed later. Our aim was to study a one-approach technique with a new, biodegradable biliary stent (BDBS) inserted duodenoscopically in treating the CD leakage in a pig. Methods: The braided, self-reinforced, ˜a-sterilised barium sulphate (BaSO4) – polylactide (PLA) BDBSs (length 50 mm, OD 7 mm) were used in this controlled study with 12 Yorkshire pigs (48 G 2.8 kg) Cholecystectomy was performed and cystic artery was ligated. CD was cut 10-20 mm from CBD without ligating. A drain was left into foramen Winslov and connected extra-abdominally into a collection sac. In duodenoscopy papilla of Vater was cannulated and cholangiography was performed. With the assistance of a guide wire, a biodegradable (Group 1) or a 10 fr, 70 mm plastic (Group 2) biliary stent was inserted into the CBD, leaving about 10 mm of the stent outside from the papilla. The volume of bile output in the drain sac was measured daily, and the drain was removed when the output had diminished into 40 ml per day. Cefuroksim antibiotic was given i.v. for 7 days postoperatively. The animals were followed by repeated abdominal x-ray and blood serum determinations for one month. Results: Cholangiography confirmed leakage from CD in all of the animals. A BDBS (Group 1) or a plastic stent (Group 2) was successfully inserted into the BD in 6/6 animals in both groups. During the followup time the pigs did not differ in blood leukocyte counts or serum liver function tests. In Group 1 (BDBS) the total output of bile into the collection drain from the abdominal cavity was smaller and the drains were removed earlier (median 3 vs 6 days after the procedure; p!0.05) compared to the Group 2 (plastic stent) animals. In the x-ray a BDBS (Group 1) or a plastic stent (Group 2) was seen in situ in 5/6 animals in both of the groups at 1 month. Conclusions: A biodegradable biliary stent seems very promising and may work even better compared to the plastic stent in the endoscopic treatment of post cholecystectomy leakage of cystic duct. Furthermore, removal of the stent is avoided.
www.mosby.com/gie
Volume 61, No. 5 : 2005 GASTROINTESTINAL ENDOSCOPY AB97