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Mo1362 Preliminary Report on a New Hybrid Metal Stent for Endoscopic Ultrasound-Guided Biliary Drainage
Abstracts
Malignant Predictor 3 Anatomy Altered Normal Predictor 4 Technique Intrahepatic Extrahepatic Predictor 5 Rendezvous Yes No Predictor 6 Stent Placement Transpapillary Transenteric Hepaticogastrostomy None Transanastomotic
N (%)
Adjusted OR* [95%CI] For Failed Outcome
Adjusted OR* [95%CI] For Complications
383 (85 %)
1.00 [Reference]
1.00 [Reference]
82 (18 %) 370 (82%)
1.45 [ 0.61 - 3.19 ] 1.00 [Reference]
1.19 [ 0.66 - 2.14 ] 1.00 [Reference]
260 (57%) 192 (43%)
1.83 [ 0.51 - 6.57 ] 1.00 [Reference]
0.73 [ 0.29 - 1.82 ] 1.00 [Reference]
48 (11%) 404 (89%)
0.58 [0.09 - 3.92] 1.00 [Reference]
0.38 [0.12 - 1.21] 1.00 [Reference]
Successful standard cannulation Advanced technique attempted: Precut EUS-intervention Technical success: Precut-immediate Precut-overall EUSintervention* Therapeutic biliary ERCP failures
Center-A: precut and/or EUS-access available
Center-B: only precut access available
P-value
947/1053 (90%)
287/330 (87%)
NS
100/1053 (9.5%) 51/ 1053 (4.8%) 49/1053 (4.7%) 37/51 (73%) 39/51 (76%) 58/61 (95%)
39/330 (11.8%) 39/330 (11.8%) –
NS ! 0.0001 –
28/39 (72%) 30/39 (77%) –
NS NS –
11/1053 (1.0%)
15/330 (4.5%)
0.0002
* Includes 12 patients with EUS-interventions attempted after failed precut; no patients had precut attempts after failed EUS-access
111 153 168 10 10
(25%) (34%) (37%) (2%) (2%)
1.00 [Reference] 5.13 [ 1.12 - 23.54 ] 2.48 [ 0.77 - 7.92 ] 48.8 [8.06 - 296.3] 1.84 [0.17 - 19.95 ]
1.00 [Reference] 0.96 [ 0.37 - 2.48 ] 1.99 [1.04 - 3.82 ] 0.33 [ 0.04 - 2.91] 0.36 [ 0.04 - 3.16 ]
* Adjusted for Gender, Stricture Type, Anatomy, Technique, Rendezvous, Stent Placement,
Mo1361 EUS-Guided Interventions Decrease the Rate of Therapeutic Biliary ERCP Failures: Comparison of ERCP Outcomes At Centers With and Without Interventional EUS Alexander Lee2, Yasser M. Bhat1, Kenneth Binmoeller1, John Cello2, Lukejohn W. Day2, Chris M. Hamerski1, Steve D. Kane1, Janak N. Shah*1 1 Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, CA; 2Division of Gastroenterology, San Francisco General Hospital, San Francisco, CA Background: Selective biliary cannulation fails in up to 10% of ERCP. Precut papillotomy is the most widely used technique for failures. EUS-interventions, such as rendezvous or EUS-guided drainage, are newer methods to facilitate therapy in failed ERCP, and are promising. However, there are limited comparative data. Aim: To evaluate the impact of EUS-interventions on therapeutic biliary ERCP, and to compare this technique to precut papillotomy. Methods: Consecutive records were retrospectively reviewed to identify all therapeutic biliary ERCPs attempted in patients with native papillae and surgically unaltered anatomy at two tertiary centers: one with and one without availability of interventional EUS. At Center-A either precut papillotomy or EUS-interventions (generally done when precut not feasible or optimal) were performed at the endoscopist’s discretion immediately after failed standard cannulation. At Center-B only precut papillotomy was utilized. Experienced endoscopists at each center performed all procedures. The following data were collected: standard cannulation success, precut success, EUS-intervention success, and ERCP failure rates (failure to complete intended therapy at 1st session). Comparative analyses were performed using Fisher’s exact test. Results: Therapeutic biliary ERCPs were attempted in 1053 and 330 patients at Centers-A and B, over 2 and 4-yr periods, respectively. Clinical indications included: malignant obstruction (51%), benign stricture (12%), stones (34%), and leak (3%). Malignant obstruction was more common at Center-A (60% vs. 28%; pZ0.0005), and stones more common at Center-B (22% vs. 63%; p!0.0001). Standard cannulation success, use of advanced techniques (EUS or precut), and precut success were similar (Table). However, precut was attempted at nearly the same rate as EUS-interventions at Center-A, and less frequently than at Center-B. ERCP failure rate was significantly lower at Center-A and was attributed to higher success with EUS techniques (95%). EUS-interventions were more successful than immediate precut access at Centers-A, B, and compared to overall precut attempts from both centers (pZ0.001, pZ0.002, pZ0.0002; respectively). EUS-interventions remained superior when accounting for eventual precut success (2nd ERCP) at Centers-A, B, and combined (pZ0.005, pZ0.01, pZ0.003; respectively). EUS-interventions included rendezvous (82%), anterograde placement of transpapillary stent (16%), and EUS-guided transmural drainage (2%). Among patients with available follow-up, complication rates of EUS-interventions (0/ 17) and precut (8/53) were not significantly different. Conclusion: EUS-guided interventions decrease the rate of therapeutic biliary ERCP failures. These techniques appear superior to precut papillotomy and optimize successful, single-session biliary access and therapy. Biliary ERCP outcomes at centers with and without availability of EUS-guided interventions.
www.giejournal.org
Mo1362 Preliminary Report on a New Hybrid Metal Stent for Endoscopic Ultrasound-Guided Biliary Drainage Tae Jun Song*1, Sang Soo Lee2, Do Hyun Park2, Dong Wan Seo2, Sung Koo Lee2, Myung-Hwan Kim2 1 Internal Medicine, Inje University Ilsanpaik Hospital, Goyang, Republic of Korea; 2Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea Backgrounds: Endoscopic ultrasound-guided biliary drainage (EUS-BD) may be a feasible and useful alternative in patients with malignant biliary obstructions after failed endoscopic retrograde cholangiopancreatography (ERCP). One of the main limitations of EUS-BD is the lack of devices specifically tailored to this technique. This study was performed to evaluate a newly developed hybrid metal stent customized for EUS-BD. Methods: A total of 27 consecutive patients with malignant biliary obstructions who were candidates for alternative techniques for biliary drainage due to failed ERCP were enrolled. The EUS-BD procedure was performed using hybrid metal stents which are partially covered self-expandable metal stents specially designed and modified for the EUS-BD procedure (Figure 1). Results: EUSguided hepaticogastrostomy (EUS-HG) was performed in 10 patients, and EUSguided choledochoduodenostomy (EUS-CD) was performed in 17 patients. The technical success rate of EUS-BD with the hybrid metal stent was 100% (27/27), and clinical success was achieved in 96.3% (26/27) of the cases. Adverse events developed in five patients (5/27, 18.5%), including a self-limited pneumoperitoneum in three patients, minor bleeding in one patient, and abdominal pain in one patient. During the follow-up period (median, 134 days), proximal or distal stent migration was not observed. Conclusions: EUS-BD with a hybrid metal stent is technically feasible and can be an effective treatment for malignant biliary obstruction after failed ERCP. Hybrid metal stents may be used safely in EUS-BD, and they can prevent stent-related adverse events.
A hybrid metal stent specially designed for EUS-guided biliary drainage. This stent is a partially covered stent with proximal and distal antimigrating flaps at both ends of the covered portion.
Volume 79, No. 5S : 2014 GASTROINTESTINAL ENDOSCOPY AB301
Malignant Predictor 3 Anatomy Altered Normal Predictor 4 Technique Intrahepatic Extrahepatic Predictor 5 Rendezvous Yes No Predictor 6 Stent Placement Transpapillary Transenteric Hepaticogastrostomy None Transanastomotic
N (%)
Adjusted OR* [95%CI] For Failed Outcome
Adjusted OR* [95%CI] For Complications
383 (85 %)
1.00 [Reference]
1.00 [Reference]
82 (18 %) 370 (82%)
1.45 [ 0.61 - 3.19 ] 1.00 [Reference]
1.19 [ 0.66 - 2.14 ] 1.00 [Reference]
260 (57%) 192 (43%)
1.83 [ 0.51 - 6.57 ] 1.00 [Reference]
0.73 [ 0.29 - 1.82 ] 1.00 [Reference]
48 (11%) 404 (89%)
0.58 [0.09 - 3.92] 1.00 [Reference]
0.38 [0.12 - 1.21] 1.00 [Reference]
Successful standard cannulation Advanced technique attempted: Precut EUS-intervention Technical success: Precut-immediate Precut-overall EUSintervention* Therapeutic biliary ERCP failures
Center-A: precut and/or EUS-access available
Center-B: only precut access available
P-value
947/1053 (90%)
287/330 (87%)
NS
100/1053 (9.5%) 51/ 1053 (4.8%) 49/1053 (4.7%) 37/51 (73%) 39/51 (76%) 58/61 (95%)
39/330 (11.8%) 39/330 (11.8%) –
NS ! 0.0001 –
28/39 (72%) 30/39 (77%) –
NS NS –
11/1053 (1.0%)
15/330 (4.5%)
0.0002
* Includes 12 patients with EUS-interventions attempted after failed precut; no patients had precut attempts after failed EUS-access
111 153 168 10 10
(25%) (34%) (37%) (2%) (2%)
1.00 [Reference] 5.13 [ 1.12 - 23.54 ] 2.48 [ 0.77 - 7.92 ] 48.8 [8.06 - 296.3] 1.84 [0.17 - 19.95 ]
1.00 [Reference] 0.96 [ 0.37 - 2.48 ] 1.99 [1.04 - 3.82 ] 0.33 [ 0.04 - 2.91] 0.36 [ 0.04 - 3.16 ]
* Adjusted for Gender, Stricture Type, Anatomy, Technique, Rendezvous, Stent Placement,
Mo1361 EUS-Guided Interventions Decrease the Rate of Therapeutic Biliary ERCP Failures: Comparison of ERCP Outcomes At Centers With and Without Interventional EUS Alexander Lee2, Yasser M. Bhat1, Kenneth Binmoeller1, John Cello2, Lukejohn W. Day2, Chris M. Hamerski1, Steve D. Kane1, Janak N. Shah*1 1 Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, CA; 2Division of Gastroenterology, San Francisco General Hospital, San Francisco, CA Background: Selective biliary cannulation fails in up to 10% of ERCP. Precut papillotomy is the most widely used technique for failures. EUS-interventions, such as rendezvous or EUS-guided drainage, are newer methods to facilitate therapy in failed ERCP, and are promising. However, there are limited comparative data. Aim: To evaluate the impact of EUS-interventions on therapeutic biliary ERCP, and to compare this technique to precut papillotomy. Methods: Consecutive records were retrospectively reviewed to identify all therapeutic biliary ERCPs attempted in patients with native papillae and surgically unaltered anatomy at two tertiary centers: one with and one without availability of interventional EUS. At Center-A either precut papillotomy or EUS-interventions (generally done when precut not feasible or optimal) were performed at the endoscopist’s discretion immediately after failed standard cannulation. At Center-B only precut papillotomy was utilized. Experienced endoscopists at each center performed all procedures. The following data were collected: standard cannulation success, precut success, EUS-intervention success, and ERCP failure rates (failure to complete intended therapy at 1st session). Comparative analyses were performed using Fisher’s exact test. Results: Therapeutic biliary ERCPs were attempted in 1053 and 330 patients at Centers-A and B, over 2 and 4-yr periods, respectively. Clinical indications included: malignant obstruction (51%), benign stricture (12%), stones (34%), and leak (3%). Malignant obstruction was more common at Center-A (60% vs. 28%; pZ0.0005), and stones more common at Center-B (22% vs. 63%; p!0.0001). Standard cannulation success, use of advanced techniques (EUS or precut), and precut success were similar (Table). However, precut was attempted at nearly the same rate as EUS-interventions at Center-A, and less frequently than at Center-B. ERCP failure rate was significantly lower at Center-A and was attributed to higher success with EUS techniques (95%). EUS-interventions were more successful than immediate precut access at Centers-A, B, and compared to overall precut attempts from both centers (pZ0.001, pZ0.002, pZ0.0002; respectively). EUS-interventions remained superior when accounting for eventual precut success (2nd ERCP) at Centers-A, B, and combined (pZ0.005, pZ0.01, pZ0.003; respectively). EUS-interventions included rendezvous (82%), anterograde placement of transpapillary stent (16%), and EUS-guided transmural drainage (2%). Among patients with available follow-up, complication rates of EUS-interventions (0/ 17) and precut (8/53) were not significantly different. Conclusion: EUS-guided interventions decrease the rate of therapeutic biliary ERCP failures. These techniques appear superior to precut papillotomy and optimize successful, single-session biliary access and therapy. Biliary ERCP outcomes at centers with and without availability of EUS-guided interventions.
www.giejournal.org
Mo1362 Preliminary Report on a New Hybrid Metal Stent for Endoscopic Ultrasound-Guided Biliary Drainage Tae Jun Song*1, Sang Soo Lee2, Do Hyun Park2, Dong Wan Seo2, Sung Koo Lee2, Myung-Hwan Kim2 1 Internal Medicine, Inje University Ilsanpaik Hospital, Goyang, Republic of Korea; 2Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea Backgrounds: Endoscopic ultrasound-guided biliary drainage (EUS-BD) may be a feasible and useful alternative in patients with malignant biliary obstructions after failed endoscopic retrograde cholangiopancreatography (ERCP). One of the main limitations of EUS-BD is the lack of devices specifically tailored to this technique. This study was performed to evaluate a newly developed hybrid metal stent customized for EUS-BD. Methods: A total of 27 consecutive patients with malignant biliary obstructions who were candidates for alternative techniques for biliary drainage due to failed ERCP were enrolled. The EUS-BD procedure was performed using hybrid metal stents which are partially covered self-expandable metal stents specially designed and modified for the EUS-BD procedure (Figure 1). Results: EUSguided hepaticogastrostomy (EUS-HG) was performed in 10 patients, and EUSguided choledochoduodenostomy (EUS-CD) was performed in 17 patients. The technical success rate of EUS-BD with the hybrid metal stent was 100% (27/27), and clinical success was achieved in 96.3% (26/27) of the cases. Adverse events developed in five patients (5/27, 18.5%), including a self-limited pneumoperitoneum in three patients, minor bleeding in one patient, and abdominal pain in one patient. During the follow-up period (median, 134 days), proximal or distal stent migration was not observed. Conclusions: EUS-BD with a hybrid metal stent is technically feasible and can be an effective treatment for malignant biliary obstruction after failed ERCP. Hybrid metal stents may be used safely in EUS-BD, and they can prevent stent-related adverse events.
A hybrid metal stent specially designed for EUS-guided biliary drainage. This stent is a partially covered stent with proximal and distal antimigrating flaps at both ends of the covered portion.
Volume 79, No. 5S : 2014 GASTROINTESTINAL ENDOSCOPY AB301