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Akira Andoh - One of the best experts on this subject based on the ideXlab platform.
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Utility and safety of a new uneven double-lumen Sphincterotome in cases of difficult biliary cannulation.
BMC gastroenterology, 2021Co-Authors: Shuhei Shintani, Osamu Inatomi, Yoshiya Takeda, Hiroshi Matsumoto, Takehide Fujimoto, Yoshihisa Tsuji, Hiromu Kutsumi, Akira AndohAbstract:BACKGROUND We investigated the utility and safety of a new uneven double-lumen Sphincterotome in biliary cannulation in comparison with the conventional pancreatic guidewire (PGW) method. METHODS We retrospectively evaluated 119 patients who required PGW placement because of difficult biliary cannulation. Endoscopic retrograde cholangiopancreatography (ERCP) was performed using a conventional ERCP catheter or a new uneven double-lumen Sphincterotome. The success rate of bile duct cannulation, the operation time of bile duct cannulation, and the incidence of post-ERCP pancreatitis (PEP) were evaluated. RESULTS Forty-four patients were treated with a new double-lumen Sphincterotome (the new Sphincterotome group) and 75 patients underwent conventional PGW placement (the conventional group). The success rate of bile duct cannulation was 39/44 (88.6%) in the new Sphincterotome group and 63/75 (84.0%) in the conventional group (not significant). The total biliary cannulation time (from the reach to the papilla to the finish of biliary cannulation) was 16.0 (6.5-78) min in the new Sphincterotome group and 26.0 (5-80) min in the conventional group (P
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utility and safety of a new uneven double lumen Sphincterotome in cases of difficult biliary cannulation
BMC Gastroenterology, 2021Co-Authors: Shuhei Shintani, Osamu Inatomi, Yoshiya Takeda, Hiroshi Matsumoto, Takehide Fujimoto, Yoshihisa Tsuji, Hiromu Kutsumi, Akira AndohAbstract:BACKGROUND We investigated the utility and safety of a new uneven double-lumen Sphincterotome in biliary cannulation in comparison with the conventional pancreatic guidewire (PGW) method. METHODS We retrospectively evaluated 119 patients who required PGW placement because of difficult biliary cannulation. Endoscopic retrograde cholangiopancreatography (ERCP) was performed using a conventional ERCP catheter or a new uneven double-lumen Sphincterotome. The success rate of bile duct cannulation, the operation time of bile duct cannulation, and the incidence of post-ERCP pancreatitis (PEP) were evaluated. RESULTS Forty-four patients were treated with a new double-lumen Sphincterotome (the new Sphincterotome group) and 75 patients underwent conventional PGW placement (the conventional group). The success rate of bile duct cannulation was 39/44 (88.6%) in the new Sphincterotome group and 63/75 (84.0%) in the conventional group (not significant). The total biliary cannulation time (from the reach to the papilla to the finish of biliary cannulation) was 16.0 (6.5-78) min in the new Sphincterotome group and 26.0 (5-80) min in the conventional group (P < 0.01). The time from PGW placement to bile duct cannulation was 3.5 (0.3-57) min in the magictome group and 12.0 (1-65) min in the conventional group (P < 0.01). Hyperamylasemia was observed in 13/44 (29.5%) and 17/75 (22.7%), respectively (not significant). Five of 44 (11.3%) of the new Sphincterotome group and 14/75 (18.7%) of the conventional group were diagnosed with PEP (not significant). CONCLUSION A new double-lumen Sphincterotome allows selective bile duct cannulation to be performed in a shorter time than the conventional PGW method.
Todd H Baron - One of the best experts on this subject based on the ideXlab platform.
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precut sphincterotomy for selective biliary duct cannulation during endoscopic retrograde cholangiopancreatography
Annals of Gastroenterology, 2012Co-Authors: Tomas Davee, Jairo A Garcia, Todd H BaronAbstract:Selective biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP) is required to perform all therapeutic biliary procedures. Despite major advances in imaging, guidewires and Sphincterotome catheter designs, the success rate for biliary cannulation by experienced endoscopists during ERCP is approximately 85% when standard cannulation techniques are applied. Precut sphincterotomy, also known as access sphincterotomy, is performed when standard techniques fail to achieve selective biliary cannulation. Precut sphincterotomy significantly increases the rate of biliary cannulation up to 98%. However, precut sphincterotomy has traditionally been considered a risk factor for adverse events following ERCP, especially concerning is post-ERCP pancreatitis which results in significant morbidity and financial burden. Recent evidence suggests that precut sphincterotomy alone may not be a risk factor for pancreatitis; rather repeated attempts (≥10) at biliary cannulation prior to precut sphincterotomy may be the actual cause of post-ERCP pancreatitis. In this paper, we review the different variations of the precut sphincterotomy technique and their corresponding rates of success and adverse events.
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Outcome of access sphincterotomy using a needle knife converted from a standard biliary Sphincterotome.
Endoscopy, 2012Co-Authors: Nayantara Coelho-prabhu, I. Dzeletovic, Todd H BaronAbstract:Cannulation fails in up to 10 % of all endoscopic retrograde cholangiopancreatographies (ERCPs). A standard Sphincterotome can be converted to a needle knife to perform precut sphincterotomy (PCS). In this retrospective study, we analyzed cannulation rates, adverse events, and the percentage of patients requiring a second Sphincterotome using a converted needle knife. Over a 7-year period, 3322 ERCPs were performed by one experienced therapeutic endoscopist; 1487 sphincterotomies were performed, 78 precut sphincterotomies using a converted needle knife. Successful cannulation using the converted needle knife was achieved in 96 % of cases at the initial procedure. Adverse events occurred in 17 % and post-ERCP pancreatitis was reported in 10 % of patients. A second Sphincterotome was needed in 13 % of cases. This study shows a converted needle knife can be used for successful cannulation of either the biliary or the pancreatic duct after a failed cannulation with a standard Sphincterotome, with a low percentage of adverse events anda reduction in the need for accessories.
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how many times can you reuse a single use Sphincterotome a prospective evaluation
Gastrointestinal Endoscopy, 1998Co-Authors: Mel C Wilcox, Wilma Geels, Todd H BaronAbstract:Abstract Background: The decreasing reimbursement for endoscopic supplies has prompted evaluation of reuse of "single use" items. Methods: Over a 12.5-month period, numbered Sphincterotomes were used for sphincterotomy or as a diagnostic catheter in all patients undergoing endoscopic retrograde cholangiopancreatography. Before first use and after each subsequent use, the resistance of the Sphincterotome was measured with an ohmmeter. After each use, the Sphincterotome was thoroughly cleaned and gas sterilized. Sphincterotomes that could not be adequately cleaned or would not function properly were discarded. The endoscopist was blinded to the number of prior uses of the Sphincterotome. Results: During the study period, 80 Sphincterotomes were used 290 times, including use in 162 sphincterotomies. The median number of uses before discarding was 3 and ranged from 0 to 10. The single most common reason for discarding the Sphincterotome was breakage of the wire to the handle which occurred after 1 to 9 uses. The Sphincterotome did not cut inappropriately in any patient, and no complications were linked to reuse. Equipment costs to our unit were reduced $21,000 by reuse. Conclusions: "Single use" Sphincterotomes can be safely reused multiple times without compromising their use as a diagnostic or therapeutic device. (Gastrointest Endosc 1998;48:58-60.)
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How many times can you reuse a “single-use” Sphincterotome? A prospective evaluation
Gastrointestinal endoscopy, 1998Co-Authors: C. Mel Wilcox, Wilma Geels, Todd H BaronAbstract:Abstract Background: The decreasing reimbursement for endoscopic supplies has prompted evaluation of reuse of "single use" items. Methods: Over a 12.5-month period, numbered Sphincterotomes were used for sphincterotomy or as a diagnostic catheter in all patients undergoing endoscopic retrograde cholangiopancreatography. Before first use and after each subsequent use, the resistance of the Sphincterotome was measured with an ohmmeter. After each use, the Sphincterotome was thoroughly cleaned and gas sterilized. Sphincterotomes that could not be adequately cleaned or would not function properly were discarded. The endoscopist was blinded to the number of prior uses of the Sphincterotome. Results: During the study period, 80 Sphincterotomes were used 290 times, including use in 162 sphincterotomies. The median number of uses before discarding was 3 and ranged from 0 to 10. The single most common reason for discarding the Sphincterotome was breakage of the wire to the handle which occurred after 1 to 9 uses. The Sphincterotome did not cut inappropriately in any patient, and no complications were linked to reuse. Equipment costs to our unit were reduced $21,000 by reuse. Conclusions: "Single use" Sphincterotomes can be safely reused multiple times without compromising their use as a diagnostic or therapeutic device. (Gastrointest Endosc 1998;48:58-60.)
Shuhei Shintani - One of the best experts on this subject based on the ideXlab platform.
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Utility and safety of a new uneven double-lumen Sphincterotome in cases of difficult biliary cannulation.
BMC gastroenterology, 2021Co-Authors: Shuhei Shintani, Osamu Inatomi, Yoshiya Takeda, Hiroshi Matsumoto, Takehide Fujimoto, Yoshihisa Tsuji, Hiromu Kutsumi, Akira AndohAbstract:BACKGROUND We investigated the utility and safety of a new uneven double-lumen Sphincterotome in biliary cannulation in comparison with the conventional pancreatic guidewire (PGW) method. METHODS We retrospectively evaluated 119 patients who required PGW placement because of difficult biliary cannulation. Endoscopic retrograde cholangiopancreatography (ERCP) was performed using a conventional ERCP catheter or a new uneven double-lumen Sphincterotome. The success rate of bile duct cannulation, the operation time of bile duct cannulation, and the incidence of post-ERCP pancreatitis (PEP) were evaluated. RESULTS Forty-four patients were treated with a new double-lumen Sphincterotome (the new Sphincterotome group) and 75 patients underwent conventional PGW placement (the conventional group). The success rate of bile duct cannulation was 39/44 (88.6%) in the new Sphincterotome group and 63/75 (84.0%) in the conventional group (not significant). The total biliary cannulation time (from the reach to the papilla to the finish of biliary cannulation) was 16.0 (6.5-78) min in the new Sphincterotome group and 26.0 (5-80) min in the conventional group (P
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utility and safety of a new uneven double lumen Sphincterotome in cases of difficult biliary cannulation
BMC Gastroenterology, 2021Co-Authors: Shuhei Shintani, Osamu Inatomi, Yoshiya Takeda, Hiroshi Matsumoto, Takehide Fujimoto, Yoshihisa Tsuji, Hiromu Kutsumi, Akira AndohAbstract:BACKGROUND We investigated the utility and safety of a new uneven double-lumen Sphincterotome in biliary cannulation in comparison with the conventional pancreatic guidewire (PGW) method. METHODS We retrospectively evaluated 119 patients who required PGW placement because of difficult biliary cannulation. Endoscopic retrograde cholangiopancreatography (ERCP) was performed using a conventional ERCP catheter or a new uneven double-lumen Sphincterotome. The success rate of bile duct cannulation, the operation time of bile duct cannulation, and the incidence of post-ERCP pancreatitis (PEP) were evaluated. RESULTS Forty-four patients were treated with a new double-lumen Sphincterotome (the new Sphincterotome group) and 75 patients underwent conventional PGW placement (the conventional group). The success rate of bile duct cannulation was 39/44 (88.6%) in the new Sphincterotome group and 63/75 (84.0%) in the conventional group (not significant). The total biliary cannulation time (from the reach to the papilla to the finish of biliary cannulation) was 16.0 (6.5-78) min in the new Sphincterotome group and 26.0 (5-80) min in the conventional group (P < 0.01). The time from PGW placement to bile duct cannulation was 3.5 (0.3-57) min in the magictome group and 12.0 (1-65) min in the conventional group (P < 0.01). Hyperamylasemia was observed in 13/44 (29.5%) and 17/75 (22.7%), respectively (not significant). Five of 44 (11.3%) of the new Sphincterotome group and 14/75 (18.7%) of the conventional group were diagnosed with PEP (not significant). CONCLUSION A new double-lumen Sphincterotome allows selective bile duct cannulation to be performed in a shorter time than the conventional PGW method.
Richard A. Kozarek - One of the best experts on this subject based on the ideXlab platform.
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In vitro study and in vivo application of a reusable double-channel Sphincterotome.
Endoscopy, 2001Co-Authors: Richard A. Kozarek, John J. Brandabur, Shannon K. RoachAbstract:Background and Study Aims: Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) has been deemed to be a cost-prohibitive procedure, based upon the cumulative costs of one-time-use accessories and current reimbursement plans. One-time-use Sphincterotomes comprise a significant component of that cost and, accordingly, we evaluated the disability and clinical usefulness of a recently introduced reusable double-channel Sphincterotome. Materials and Methods: We studied a reusable 6-Fr Sphincterotome at baseline and following contamination with 10 6 Bacillus stearothermophilus. Reprocessing included a unique 30-minute ultrasonic cleaning step in lieu of manual cleaning, followed by steam sterilization. Parameters evaluated included Sphincterotome function, electrical integrity, and our ability to sterilize the devices for three in vitro trials. In vivo studies included patient demographics and outcomes, procedural findings, and success rates, and the mean number of times the Sphincterotome was used, functional grading at time of use, and reasons for Sphincterotome malfunction. Results: Ten out of ten Sphincterotomes maintained form, function, and electrical integrity in vitro, and all cultures were negative after sterilization. In the initial in vivo study, ten Sphincterotomes were used in 50 patients (mean, 5 uses) with a 94% success rate. Reasons for Sphincterotome failure included leak or breakage of the accessory port in 70%, wire fracture in 10%, incorrect wire bow in 10%, and clogged injection port in 10%. Following reconfiguration of the insertion-port polymer, an additional ten Sphincterotomes were used in 110 patients (mean, 11 uses). Mechanical failure occurred primarily at the wire-insertion port, resulting in progressive friction with reuse. There were neither electrical nor infectious complications associated with reuse. Conclusions: A reusable double-channel Sphincterotome is available which can theoretically be reprocessed and sterilized without the manual cleaning step of the reprocessing process. Contingent upon both provider and patient, multiple reuse can be anticipated, and contingent upon purchase price and reprocessing costs, the potential for procedural cost savings is significant.
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In vitro and in vivo evaluation of a reusable double-channel Sphincterotome.
Gastrointestinal Endoscopy, 1999Co-Authors: Roger M. Lee, Francisco Vida, Richard A. Kozarek, Shirley L. Raltz, T.j. Ball, David J. Patterson, John J. Brandabur, Michael Gluck, Alberto Tomas, Stanford E. SumidaAbstract:Abstract Background: To date, one reusable, double-channel Sphincterotome has been approved by the Food and Drug Administration in the United States. Whether this device can be reprocessed easily and whether it is more durable than currently manufactured disposable Sphincterotomes are uncertain. Methods: Thirty double-channel, 20 mm, braided-wire Sphincterotomes approved for multiple uses were studied in vitro/in vivo with regard to durability and sterilization. A cost analysis of reusable, disposable, and reprocessed disposable Sphincterotomes was also carried out. Results: Three of 10 Sphincterotomes evaluated in vitro broke after 3, 4, and 8 uses. Electrical integrity was preserved after 10 uses in the remaining Sphincterotomes. Nine Sphincterotomes remained functional for at least 3 uses, five for 6 uses, and one for 10 uses. Culture results after inoculation demonstrated contamination with surviving organisms after manual cleaning and no growth after ethylene oxide sterilization. Sixty-one procedures were performed in vivo using 20 Sphincterotomes (mean number of uses 3.1). No evidence of procedurally related infection occurred with reuse. Cost per use of this reusable Sphincterotome was calculated to be $62.98; it became cost effective after 2.2 and 7.9 uses when compared with disposable and reprocessed, disposable Sphincterotomes, respectively. Conclusions: This reusable Sphincterotome proved to be safe, easily sterilized, and electrically intact after repeated use. In vivo, however, a progressive loss of function limited the mean number of uses to 3.1. In settings that preclude reuse of reprocessed disposable accessories, this reusable Sphincterotome may provide a means to decrease costs associated with endoscopic retrograde cholangiopancreatography. (Gastrointest Endosc 1999;49:477-82.)
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In vitro and in vivo evaluation of a reusable double-channel Sphincterotome.
Gastrointestinal endoscopy, 1999Co-Authors: Roger M. Lee, Francisco Vida, Richard A. Kozarek, Shirley L. Raltz, T.j. Ball, David J. Patterson, John J. Brandabur, Michael Gluck, Alberto Tomas, Stanford E. SumidaAbstract:To date, one reusable, double-channel Sphincterotome has been approved by the Food and Drug Administration in the United States. Whether this device can be reprocessed easily and whether it is more durable than currently manufactured disposable Sphincterotomes are uncertain. Thirty double-channel, 20 mm, braided-wire Sphincterotomes approved for multiple uses were studied in vitro/in vivo with regard to durability and sterilization. A cost analysis of reusable, disposable, and reprocessed disposable Sphincterotomes was also carried out. Three of 10 Sphincterotomes evaluated in vitro broke after 3, 4, and 8 uses. Electrical integrity was preserved after 10 uses in the remaining Sphincterotomes. Nine Sphincterotomes remained functional for at least 3 uses, five for 6 uses, and one for 10 uses. Culture results after inoculation demonstrated contamination with surviving organisms after manual cleaning and no growth after ethylene oxide sterilization. Sixty-one procedures were performed in vivo using 20 Sphincterotomes (mean number of uses 3.1). No evidence of procedurally related infection occurred with reuse. Cost per use of this reusable Sphincterotome was calculated to be $62.98; it became cost effective after 2.2 and 7.9 uses when compared with disposable and reprocessed, disposable Sphincterotomes, respectively. This reusable Sphincterotome proved to be safe, easily sterilized, and electrically intact after repeated use. In vivo, however, a progressive loss of function limited the mean number of uses to 3.1. In settings that preclude reuse of reprocessed disposable accessories, this reusable Sphincterotome may provide a means to decrease costs associated with endoscopic retrograde cholangiopancreatography.
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Reuse of disposable Sphincterotomes for diagnostic and therapeutic ERCP: a one-year prospective study
Gastrointestinal endoscopy, 1999Co-Authors: Richard A. Kozarek, Shirley L. Raltz, T.j. Ball, David J. Patterson, John J. BrandaburAbstract:Abstract Background: Although previous studies have documented that single-channel Sphincterotomes can be sterilized and used up to 10 times, no studies have prospectively evaluated the reuse of disposable Sphincterotomes. Methods: Five- and six-French double-channel Sphincterotomes marketed as one-time-use only were manually cleaned, sterilized with ethylene oxide, and used up to 10 times. Over a 1-year period, total number of uses as a cannulation or cutting device, reason for Sphincterotome dysfunction, possible infectious complications were evaluated, and cost-savings associated with reuse were evaluated. Results: The mean number of times Sphincterotomes could be used in our institution was 3.4; a broken or stiff cutting wire was the main reason for discard. There were two infectious complications during the study period. Both were experienced by patients with unrelieved obstruction treated with new Sphincterotomes. Contingent on the method used, total savings related to Sphincterotome reuse was approximately $66,000. Conclusions: Double-channel Sphincterotomes marketed as one-time-use items can be reused safely when properly cleaned. Reuse was associated with significant cost savings in our institution. (Gastrointest Endosc 1999;49:39-42.)
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In vitro evaluation of wire integrity and ability to reprocess single-use Sphincterotomes
Gastrointestinal endoscopy, 1997Co-Authors: Richard A. Kozarek, Shirley L. Raltz, Stanford E. Sumida, Linda D. Merriam, David C. IrizarryAbstract:Abstract Background: Sphincterotomes are currently marketed as one-time-use items and constitute considerable cumulative expense in a busy endoscopy unit. It is uncertain whether these accessories can be safely reprocessed without loss of form and function. Methods: We studied disposable Sphincterotomes (five 5F, five 6F) in vitro as to their durability, electrical integrity, and ability to be adequately cleaned both manually and with ethylene oxide after contamination with 10 5 to 10 6 Mycobacterium chelonei . Results: Seven of the 10 Sphincterotomes withstood the rigors of reuse; three 6F Sphincterotomes developed wire fracture between four and eight uses. Electrical integrity, as measured by an electrosurgical analyzer, remained intact up to time of breakage in all Sphincterotomes. Manual cleaning followed by glutaraldehyde soak resulted in residual mycobacterial colonies in five 6F Sphincterotomes and a single 5F Sphincterotome. No instrument had residual organisms cultured following manual cleaning and ethylene oxide sterilization. Conclusions: The authors conclude that one-time-use Sphincterotomes have the potential for safe reuse. (Gastrointest Endosc 1996;45:117-21.)
Hiroshi Matsumoto - One of the best experts on this subject based on the ideXlab platform.
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Utility and safety of a new uneven double-lumen Sphincterotome in cases of difficult biliary cannulation.
BMC gastroenterology, 2021Co-Authors: Shuhei Shintani, Osamu Inatomi, Yoshiya Takeda, Hiroshi Matsumoto, Takehide Fujimoto, Yoshihisa Tsuji, Hiromu Kutsumi, Akira AndohAbstract:BACKGROUND We investigated the utility and safety of a new uneven double-lumen Sphincterotome in biliary cannulation in comparison with the conventional pancreatic guidewire (PGW) method. METHODS We retrospectively evaluated 119 patients who required PGW placement because of difficult biliary cannulation. Endoscopic retrograde cholangiopancreatography (ERCP) was performed using a conventional ERCP catheter or a new uneven double-lumen Sphincterotome. The success rate of bile duct cannulation, the operation time of bile duct cannulation, and the incidence of post-ERCP pancreatitis (PEP) were evaluated. RESULTS Forty-four patients were treated with a new double-lumen Sphincterotome (the new Sphincterotome group) and 75 patients underwent conventional PGW placement (the conventional group). The success rate of bile duct cannulation was 39/44 (88.6%) in the new Sphincterotome group and 63/75 (84.0%) in the conventional group (not significant). The total biliary cannulation time (from the reach to the papilla to the finish of biliary cannulation) was 16.0 (6.5-78) min in the new Sphincterotome group and 26.0 (5-80) min in the conventional group (P
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utility and safety of a new uneven double lumen Sphincterotome in cases of difficult biliary cannulation
BMC Gastroenterology, 2021Co-Authors: Shuhei Shintani, Osamu Inatomi, Yoshiya Takeda, Hiroshi Matsumoto, Takehide Fujimoto, Yoshihisa Tsuji, Hiromu Kutsumi, Akira AndohAbstract:BACKGROUND We investigated the utility and safety of a new uneven double-lumen Sphincterotome in biliary cannulation in comparison with the conventional pancreatic guidewire (PGW) method. METHODS We retrospectively evaluated 119 patients who required PGW placement because of difficult biliary cannulation. Endoscopic retrograde cholangiopancreatography (ERCP) was performed using a conventional ERCP catheter or a new uneven double-lumen Sphincterotome. The success rate of bile duct cannulation, the operation time of bile duct cannulation, and the incidence of post-ERCP pancreatitis (PEP) were evaluated. RESULTS Forty-four patients were treated with a new double-lumen Sphincterotome (the new Sphincterotome group) and 75 patients underwent conventional PGW placement (the conventional group). The success rate of bile duct cannulation was 39/44 (88.6%) in the new Sphincterotome group and 63/75 (84.0%) in the conventional group (not significant). The total biliary cannulation time (from the reach to the papilla to the finish of biliary cannulation) was 16.0 (6.5-78) min in the new Sphincterotome group and 26.0 (5-80) min in the conventional group (P < 0.01). The time from PGW placement to bile duct cannulation was 3.5 (0.3-57) min in the magictome group and 12.0 (1-65) min in the conventional group (P < 0.01). Hyperamylasemia was observed in 13/44 (29.5%) and 17/75 (22.7%), respectively (not significant). Five of 44 (11.3%) of the new Sphincterotome group and 14/75 (18.7%) of the conventional group were diagnosed with PEP (not significant). CONCLUSION A new double-lumen Sphincterotome allows selective bile duct cannulation to be performed in a shorter time than the conventional PGW method.
