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Multi-Center Evaluation of a SpyGlass System for Percutaneous Examination of the Biliary System
Abstracts
p ! 0.0001) and use of a tritome (p Z 0.004). Fluoroscopy time also increased with age (p ! 0.0001). Mean fluoroscopy times (minutes) with 95% confidence intervals for different diagnoses were as follows: CBD stones (n Z 443) 5.12 (3.05-4.07), benign biliary strictures (n Z 135) 3.94 (3.26-4.63), malignant biliary strictures (n Z 124) 5.82 (4.80-6.85) , chronic pancreatitis (n Z 49) 4.53 (3.445.63), bile leak (n Z 26) 3.67 (2.23-5.09), ampullary mass (n Z 11) 3.88 (1.286.48). When no pathology was seen (n Z 195) the mean fluoroscopy time was 3.56 minutes (3.05-4.07). Comparison by t test determined that the only two diagnoses where fluoroscopy time was significantly different from the reference diagnosis of ‘‘no pathology seen’’ were CBD stones (p ! 0.0001) and malignant strictures (p ! 0.0001). Conclusions: Therefore, several factors have been shown to significantly affect fluoroscopy time, including age, diagnosis, endoscopist and the number and nature of procedures performed. From our analysis elderly patients with biliary stones or a malignant stricture are likely to require the longest duration of fluoroscopy. The factors associated with longer fluoroscopy time warrant further investigation. A prospective study investigating these factors is ongoing in our institution.
The goal of this pilot retrospective study was to evaluate the feasibility of percutaneous use of the SpyGlass system (Boston Scientific) for intraductal diagnosis (Biopsy) and therapy (EHL) of the biliary system in patients referred for percutaneous transhepatic cholangiography (PTC). Methods: Percutaneous access to the bile duct was achieved by the interventional radiologists using standard techniques. Once access was obtained the SpyGlass scope loaded with the SpyGlass optical probe was introduced into the bile duct using a standard 10Fr sheath (n Z 7). In one patient, the optical probe and spy bite forceps alone were introduced through a 7 Fr sheath. Direct visualization was achieved in all cases. Results: 8 patients underwent Percutaneous SpyGlass cases between 12/06 and 11/ 07 at both institutions. See table. Conclusions: Direct percutaneous visualization of the biliary system using the SpyGlass system was successful and expanded the diagnostic and therapeutic capabilities of PTC. Future studies and design of delivery catheters should be addressed for percutaneous application of SpyGlass cholangioscopy.
T1510 SpyGlass Cholangioscopy– Impact On Patients with Bile Duct Filling Defect(s) of Uncertain Etiology Ayman M. Abdel Aziz, Stuart Sherman, Kenneth F. Binmoeller, Jacques Deviere, Robert H. Hawes, Oleh Haluszka, Horst Neuhaus, Douglas Pleskow, Isaac Raijman
Patient Age Gender 1) 57 M
Indications for cholangioscopy IHD stones
Reason for percutaneous approach Roux-en-Y
2) 77
M
CBD stones
Roux-en-Y
CBD stones
3) 81
F
IHD stones
Roux-en-Y
4) 65
M
IHD stones
Roux-en-Y
5) 66
M
IHD stones
Roux-en-Y
6) 35
F
Hilar stricture
Failed ERC elsewhere
7) 63
F
CBD mass
Whipple
IHD stones EHL IHD stones EHL IHD stones EHL Benign appearance and biopsy Stones
8) 67
F
PSC stricture
Hilar stricture. PTC elsewhere
Background: Direct visualization of the bile duct, tissue sampling and therapeutic interventions by current cholangioscopes has been limited by reduced scope maneuverability, poor irrigation capabilities and the need for more than one operator. With the 4-way tip deflection steering, dedicated irrigation/working channels, the single-operator SpyGlass Direct Visualization System (DVS) (Boston Scientific, Natick, USA) has overcome many of these limitations. Objective: To evaluate the SpyGlass DVS impact on patient care in cases with bile duct filling defects of uncertain origin identified on endoscopic retrograde cholangiography (ERC). Setting: Multicenter study. Methods: Twenty patients (11 men, 9 women, aged 28-91 years with a mean age of 55.8 years) with bile duct filling defect(s) detected by ERC who underwent SpyGlass DVS to evaluate the etiology, obtain visually guided biopsies or for further stone management were included in the study. Indications for ERC (based on other imaging studies) were suspected stones (n Z 10), intraductal mass (n Z 7) and mass versus stone (n Z 3). The ERC findings in these patients were questioned stones only (n Z 11), suspected benign lesions (n Z 3), suspected malignant lesions (n Z 4), and indeterminate mass (n Z 2). SpyGlass DVS indications were assessment of the filling defect and further stone management using SpyGlass directed electrohydraulic lithotripsy (EHL). Results: See table. The SpyGlass DVS was completed successfully in all patients. SpyGlass visualization followed by tissue sampling (Spyglass-directed) was done in 6 patients. Histological examination of the SpyGlass directed biopsies confirmed the SpyGlass cholangioscopic picture in all 6 patients. Recommended follow-up based on SpyGlass DVS findings were SpyGlass directed EHL in 40% of patients for large stones (which could not be removed by conventional methods) and surgery in 20% of patients. Complete stone retrieval was achieved after SpyGlass directed EHL in all cases. Conclusions: SpyGlass DVS with and without biopsy is highly accurate in identifying the etiology of bile duct filling defects of uncertain origin and has a favorable impact on patient care. SpyGlass directed stone therapy was highly effective in subjects with failed conventional stone therapy and in identifying stones missed by ERC.
ERC Questioned Stones (n Z 11) SpyGlass showing stones SpyGlass showing benign lesion SpyGlass showing malignant lesion SpyGlass showing air bubbles
ERC Suspected Benign Lesion (n Z 3)
9
1
1
ERC Suspected Malignant Lesion (n Z 4)
ERC Indeterminate Mass (n Z 2)
2
1
1
1
2
1 1
T1511 Multi-Center Evaluation of a SpyGlass System for Percutaneous Examination of the Biliary System Isaac Raijman, Adam Slivka Background: Percutaneous direct visualization of the pancreaticobiliary system may help increase diagnosis and treatment options in patients where traditional ERCP is not possible because of failure to access the biliary tree or an inaccessible papilla.
www.giejournal.org
Spyglass findings IHD stones EHL
Nodular mucosa, negative biopsy
Outcome
Complications
Stones removed
Minimal mucosal oozing from EHL probe None
Stones removed Stones removed Stones removed Stones removed Biliary reconstruction Stones removed Liver transplant
None None None None
None None
T1512 Double Balloon Enteroscopy (DBE) Can Be Routinely Employed to Perform ERCP in Bariatric Gastric Bypass (RYGB) Patients Simon K. Lo, Gauree Gupta, Richard A. Kozarek, Charles E. Dye, Ananya Das, Andrew S. Ross Pancreaticobiliary complaints are common in RYGB patients and are difficult to investigate by ERCP because of a long small bowel limb and lack of special endoscopic equipment. DBE has been effective in performing ERCP in a very small number of patients. Aim: Report on the DBE-ERCP experience in RYGB patients in 6 major U.S. DBE centers. Methods: Retrospective review of the experience of all attempted DBE-ERCP cases in RYGB patients during 1/06-11/07. Results: Two institutions did not perform any procedure and 3 attempted once. One center attempted DBE-ERCP 17 times. Procedure indications: abdominal pain (14), suspected biliary stones (4), obstructive jaundice (1), cholangitis (2), recurrent liver abscess (1) and pancreatitis (4). Patients’ mean BMI Z 29.7. All patients had intact papillae. The maximum distance reached: stomach (13), duodenum (3), afferent limb (1), jejunojejunostomy anastomosis (2). DBE passage was aborted when a large gastrogastric fistula was found in 1 patient. A duodenoscope was used instead to carry out the ERCP through the fistula. Eleven cases were done with a soft cap at the tip of the scope. Excluding the gastrogastric fistula case, 12 ERCP were considerd technical success, 2 were partial success and 5 were failures (could not reach the duodenum for cannulation-3; failed cannulation-2). The mean total procedure time for those with records was 103 minutes and ERCP alone (from cannulation to completion) took 42 minutes to do. Therapeutic maneuvers: biliary sphincterotomy-12; balloon sphincter dilation-9; clipping of a retroperitoneal perforation-1. Of 16 attempted cannulations, 11 were assisted with a cap and 5 without. There was no significant difference between the 2 groups. 9 successful cannulations were aided by a guidewire and 5 by needle knife precutting. Complications included 1 severe non-pancreatitis abdominal pain and 1 selflimited retroperitoneal perforation. In spite of frequent sphincter dilation (n Z 11, all done after a sphincterotomy), no pancreatitis was encountered. In the institution where 17 cases were done, the last 9 attempts were successful and they coincided with the introduction of a self-made cannulation and sphincterotomy device. Conclusions: In spite of increasing demand, DBE-ERCP is exceedingly difficult and is rarely done in RYGB patients. Failure is common, with 16% caused by problems in reaching the major papilla and 11% by failed cannulation. Half of our centers are either unable to or choose not to perform this procedure. But with experience and a modified cannulation/ injection/sphincterotomy device, DBE-ERCP can be successfully carried out in most cases.
Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB235
p ! 0.0001) and use of a tritome (p Z 0.004). Fluoroscopy time also increased with age (p ! 0.0001). Mean fluoroscopy times (minutes) with 95% confidence intervals for different diagnoses were as follows: CBD stones (n Z 443) 5.12 (3.05-4.07), benign biliary strictures (n Z 135) 3.94 (3.26-4.63), malignant biliary strictures (n Z 124) 5.82 (4.80-6.85) , chronic pancreatitis (n Z 49) 4.53 (3.445.63), bile leak (n Z 26) 3.67 (2.23-5.09), ampullary mass (n Z 11) 3.88 (1.286.48). When no pathology was seen (n Z 195) the mean fluoroscopy time was 3.56 minutes (3.05-4.07). Comparison by t test determined that the only two diagnoses where fluoroscopy time was significantly different from the reference diagnosis of ‘‘no pathology seen’’ were CBD stones (p ! 0.0001) and malignant strictures (p ! 0.0001). Conclusions: Therefore, several factors have been shown to significantly affect fluoroscopy time, including age, diagnosis, endoscopist and the number and nature of procedures performed. From our analysis elderly patients with biliary stones or a malignant stricture are likely to require the longest duration of fluoroscopy. The factors associated with longer fluoroscopy time warrant further investigation. A prospective study investigating these factors is ongoing in our institution.
The goal of this pilot retrospective study was to evaluate the feasibility of percutaneous use of the SpyGlass system (Boston Scientific) for intraductal diagnosis (Biopsy) and therapy (EHL) of the biliary system in patients referred for percutaneous transhepatic cholangiography (PTC). Methods: Percutaneous access to the bile duct was achieved by the interventional radiologists using standard techniques. Once access was obtained the SpyGlass scope loaded with the SpyGlass optical probe was introduced into the bile duct using a standard 10Fr sheath (n Z 7). In one patient, the optical probe and spy bite forceps alone were introduced through a 7 Fr sheath. Direct visualization was achieved in all cases. Results: 8 patients underwent Percutaneous SpyGlass cases between 12/06 and 11/ 07 at both institutions. See table. Conclusions: Direct percutaneous visualization of the biliary system using the SpyGlass system was successful and expanded the diagnostic and therapeutic capabilities of PTC. Future studies and design of delivery catheters should be addressed for percutaneous application of SpyGlass cholangioscopy.
T1510 SpyGlass Cholangioscopy– Impact On Patients with Bile Duct Filling Defect(s) of Uncertain Etiology Ayman M. Abdel Aziz, Stuart Sherman, Kenneth F. Binmoeller, Jacques Deviere, Robert H. Hawes, Oleh Haluszka, Horst Neuhaus, Douglas Pleskow, Isaac Raijman
Patient Age Gender 1) 57 M
Indications for cholangioscopy IHD stones
Reason for percutaneous approach Roux-en-Y
2) 77
M
CBD stones
Roux-en-Y
CBD stones
3) 81
F
IHD stones
Roux-en-Y
4) 65
M
IHD stones
Roux-en-Y
5) 66
M
IHD stones
Roux-en-Y
6) 35
F
Hilar stricture
Failed ERC elsewhere
7) 63
F
CBD mass
Whipple
IHD stones EHL IHD stones EHL IHD stones EHL Benign appearance and biopsy Stones
8) 67
F
PSC stricture
Hilar stricture. PTC elsewhere
Background: Direct visualization of the bile duct, tissue sampling and therapeutic interventions by current cholangioscopes has been limited by reduced scope maneuverability, poor irrigation capabilities and the need for more than one operator. With the 4-way tip deflection steering, dedicated irrigation/working channels, the single-operator SpyGlass Direct Visualization System (DVS) (Boston Scientific, Natick, USA) has overcome many of these limitations. Objective: To evaluate the SpyGlass DVS impact on patient care in cases with bile duct filling defects of uncertain origin identified on endoscopic retrograde cholangiography (ERC). Setting: Multicenter study. Methods: Twenty patients (11 men, 9 women, aged 28-91 years with a mean age of 55.8 years) with bile duct filling defect(s) detected by ERC who underwent SpyGlass DVS to evaluate the etiology, obtain visually guided biopsies or for further stone management were included in the study. Indications for ERC (based on other imaging studies) were suspected stones (n Z 10), intraductal mass (n Z 7) and mass versus stone (n Z 3). The ERC findings in these patients were questioned stones only (n Z 11), suspected benign lesions (n Z 3), suspected malignant lesions (n Z 4), and indeterminate mass (n Z 2). SpyGlass DVS indications were assessment of the filling defect and further stone management using SpyGlass directed electrohydraulic lithotripsy (EHL). Results: See table. The SpyGlass DVS was completed successfully in all patients. SpyGlass visualization followed by tissue sampling (Spyglass-directed) was done in 6 patients. Histological examination of the SpyGlass directed biopsies confirmed the SpyGlass cholangioscopic picture in all 6 patients. Recommended follow-up based on SpyGlass DVS findings were SpyGlass directed EHL in 40% of patients for large stones (which could not be removed by conventional methods) and surgery in 20% of patients. Complete stone retrieval was achieved after SpyGlass directed EHL in all cases. Conclusions: SpyGlass DVS with and without biopsy is highly accurate in identifying the etiology of bile duct filling defects of uncertain origin and has a favorable impact on patient care. SpyGlass directed stone therapy was highly effective in subjects with failed conventional stone therapy and in identifying stones missed by ERC.
ERC Questioned Stones (n Z 11) SpyGlass showing stones SpyGlass showing benign lesion SpyGlass showing malignant lesion SpyGlass showing air bubbles
ERC Suspected Benign Lesion (n Z 3)
9
1
1
ERC Suspected Malignant Lesion (n Z 4)
ERC Indeterminate Mass (n Z 2)
2
1
1
1
2
1 1
T1511 Multi-Center Evaluation of a SpyGlass System for Percutaneous Examination of the Biliary System Isaac Raijman, Adam Slivka Background: Percutaneous direct visualization of the pancreaticobiliary system may help increase diagnosis and treatment options in patients where traditional ERCP is not possible because of failure to access the biliary tree or an inaccessible papilla.
www.giejournal.org
Spyglass findings IHD stones EHL
Nodular mucosa, negative biopsy
Outcome
Complications
Stones removed
Minimal mucosal oozing from EHL probe None
Stones removed Stones removed Stones removed Stones removed Biliary reconstruction Stones removed Liver transplant
None None None None
None None
T1512 Double Balloon Enteroscopy (DBE) Can Be Routinely Employed to Perform ERCP in Bariatric Gastric Bypass (RYGB) Patients Simon K. Lo, Gauree Gupta, Richard A. Kozarek, Charles E. Dye, Ananya Das, Andrew S. Ross Pancreaticobiliary complaints are common in RYGB patients and are difficult to investigate by ERCP because of a long small bowel limb and lack of special endoscopic equipment. DBE has been effective in performing ERCP in a very small number of patients. Aim: Report on the DBE-ERCP experience in RYGB patients in 6 major U.S. DBE centers. Methods: Retrospective review of the experience of all attempted DBE-ERCP cases in RYGB patients during 1/06-11/07. Results: Two institutions did not perform any procedure and 3 attempted once. One center attempted DBE-ERCP 17 times. Procedure indications: abdominal pain (14), suspected biliary stones (4), obstructive jaundice (1), cholangitis (2), recurrent liver abscess (1) and pancreatitis (4). Patients’ mean BMI Z 29.7. All patients had intact papillae. The maximum distance reached: stomach (13), duodenum (3), afferent limb (1), jejunojejunostomy anastomosis (2). DBE passage was aborted when a large gastrogastric fistula was found in 1 patient. A duodenoscope was used instead to carry out the ERCP through the fistula. Eleven cases were done with a soft cap at the tip of the scope. Excluding the gastrogastric fistula case, 12 ERCP were considerd technical success, 2 were partial success and 5 were failures (could not reach the duodenum for cannulation-3; failed cannulation-2). The mean total procedure time for those with records was 103 minutes and ERCP alone (from cannulation to completion) took 42 minutes to do. Therapeutic maneuvers: biliary sphincterotomy-12; balloon sphincter dilation-9; clipping of a retroperitoneal perforation-1. Of 16 attempted cannulations, 11 were assisted with a cap and 5 without. There was no significant difference between the 2 groups. 9 successful cannulations were aided by a guidewire and 5 by needle knife precutting. Complications included 1 severe non-pancreatitis abdominal pain and 1 selflimited retroperitoneal perforation. In spite of frequent sphincter dilation (n Z 11, all done after a sphincterotomy), no pancreatitis was encountered. In the institution where 17 cases were done, the last 9 attempts were successful and they coincided with the introduction of a self-made cannulation and sphincterotomy device. Conclusions: In spite of increasing demand, DBE-ERCP is exceedingly difficult and is rarely done in RYGB patients. Failure is common, with 16% caused by problems in reaching the major papilla and 11% by failed cannulation. Half of our centers are either unable to or choose not to perform this procedure. But with experience and a modified cannulation/ injection/sphincterotomy device, DBE-ERCP can be successfully carried out in most cases.
Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB235