Su1622 Efficacy and Safety of Fully Covered Self-Expandable Metallic Stents in Benign Hilar and Non-Hilar Biliary Strictures

Abstracts

removed endoscopically. Stent migration is the main drawback of FC-SEMS. The aim of this study was to evaluate the outcomes of a FC-SEMS with anchoring flaps in distal malignant strictures. Patients and Methods: A multicenter prospective registry was conducted in Spain, including patients with a distal malignant biliary obstruction secondary to a pancreatic cancer, cholangiocarcinoma, ampullary tumor or malignant lymph nodes involvement. Participants had experience both in ERCP and SEMS. Informed consent was obtained from each patient. Drainage could be definitive or temporal in patients undergoing neoadjuvant therapy. Patients were followed-up for 6 months, with scheduled follow-up visits at months 1,3 and 6. Patients could prematurely exit the study in case of death, retreatment or elective surgery after neoadjuvant therapy. Patient demographics, symptoms, tumor characteristics, procedural data, stent patency, complications and feasibility of stent removal were documented. Student t and Fisher tests were used for statistical analysis. Results: 64 patients [43 m/21 w; age: 73 yr] were enrolled in 16 academic hospitals. Jaundice was the predominant symptom (93.7%). Stricture was due to pancreatic cancer in 36 cases, cholangiocarcinoma in 15, ampullary carcinoma in 8 and lymph nodes tumoral involvement in 5. 9 patients (14%) had previously undergone cholecystectomy but cystic duct could be opacified in 26 out of the remaining 55 patients (47.2%). Indication for stenting was definitive palliation in 58 patients (90.6%) and pre-surgery in 6 patients (9.4%). Hanaro flap stent (M. I. Tech. Korea) was inserted in all cases [4 cm (nZ11); 6 cm (nZ45); 8 cm (nZ8)] with a technical success rate of 100%. Mean bilirubin levels dropped from 11.3 mg/dl at baseline to 2.1 mg/dl at month 1 (p!0.001), 2 mg/dl at month 3 (p!0.001) and 0.6 mg/dl at the end of the study (p!0.001). 16 patients died during follow up due to their tumoral disease. 6 patients underwent elective surgery after neoadjuvant therapy and the stent remained patent until surgery in all of them. The stent was endoscopically removed without any difficulty the day before surgery. Complications included stent migration [nZ1 (1.56%)], mild pancreatitis [nZ1 (1.56%)], stent obstruction due to tumor overgrowth [nZ1 (1.56%)] and cholecystitis [nZ5 (7.81%)], particularly with a patent cystic duct [4/26 vs 1/ 29 (pZ0.18)]. In 2 patients with cholecystitis the stent was removed endoscopically. Conclusions: 1. Stent migration incidence is lower than published data regarding standard FC-SEMS. 2. The incidence of other complications is similar to that reported for FC-SEMS without any anchoring system. 3. The presence of flaps do not interfere at the time of stent removal

Su1621 Self-Expandable Metal Stents vs Plastic Stents for Malignant Biliary Obstruction: a Meta-Analysis Tarek Sawas*1, Mubarak Sayyar1, Shadi AL Halabi3, John J. Vargo2 1 Internal medicine, Georgetown University Washington Hospital Center, Washington, DC; 2Gastroenterology, Cleveland clinic, Cleveland, OH; 3 Internal medicine, Cleveland clinic, Cleveland, OH

Su1622 Efficacy and Safety of Fully Covered Self-Expandable Metallic Stents in Benign Hilar and Non-Hilar Biliary Strictures Phonthep Angsuwatcharakon*1,2, Rungsun Rerknimitr2, Pradermchai Kongkam2, Wiriyaporn Ridtitid2, Tanassanee Soontornmanokul2, Pinit Kullavanijaya2 1 Anatomy, Chulalongkorn University, Patumwan, Thailand; 2Medicine, Chulalongkorn University, Patumwan, Thailand Background: Fully covered self-expandable metallic stent (FCSEMS) has been increasingly used in benign biliary stricture (BBS). According to the potential blockage of the branch ducts, its use is limited only for distal bile duct stricture. There is no data of FCSEMS treatment in BBS near biliary confluence. We aimed to study the efficacy and safety of FCSEMS in BBS at both hilar and non-hilar regions. Methods: BBS patients underwent ERCP with FCSEMS treatment between 1/2009 and 6/2013 at the King Chulalongkorn Memorial Hospital were reviewed. The stricture was classified by Bismuth classification for benign stricture (type I; the stricture is O2 cm below the confluence, type II; the stricture is within 2 cm from the confluence, type III; only the ceiling of the confluence is intact, type IV; the confluence is interrupted, type V; the stricture of hepatic duct associate with stricture on a separate right branch). In Bismuth II-IV (hilar group) the proximal end of FCSEMS was placed in one intrahepatic duct, and the plastic stent was inserted in contralateral intrahepatic duct to prevent subsegmental blockage (Figure 1A). All FCSEMS were removed at 3-6 months. Treatment success was defined as; O 60% improvement of stricture with a rapid drainage of contrast from proximal ducts during cholangiogram, and normalization of liver biochemistry. Results: Nineteen patients were recruited, 10 in hilar group and 9 in non-hilar group. The diagnoses and Bismuth types of stricture are shown in table 1. In hilar group, 6 mm FCSEMS and 10 mm FCSEMS were inserted in 4 patients and 6 patients, respectively. In non-hilar group, 6 mm FESEMS and 10 mm FCSEMS were inserted in 1 patient and 8 patients, respectively. The median durations of stent placement were 135 and 102 days in hilar and non-hilar group, respectively. Treatment success rate in hilar group was significantly lower than that of in non-hilar group (60% vs. 100%, p-value 0.033). The migration rates between hilar and non-hilar groups were not different (50% vs. 44%, p-value 0.809). However in 3 patients of hilar group, the pigtail plastic stent was additionally inserted inside the FCSEMS (stent lock, Figure 1B), and there was no migration observed in this subgroup. The migration rate in subgroup with stent lock is lower than that of without stent lock significantly (0% vs. 74%, p-value 0.038). There were 2 patients in non-hilar group developed complication after FCSEMS insertion (1 mild acute pancreatitis, and 1 microperforation of duodenum and both recovered without the need for intervention). In hilar group, there was no complication. Conclusion: FCSEMS treatment is safe in BBS. In hilar stricture, the success rate is lower than that of in distal biliary stricture. Distal stent migration rates are high in both groups, however these might be prevented by insertion of a plastic stent inside the FCSEMS.

Background: Malignant biliary obstruction results from different types of tumors including pancreatic cancer, cholangiocarcinoma, gallbladder and hepatocellular carcinoma. At the time of developing obstructive jaundice, most of these malignancies present in an advanced stage making curable surgical resection not possible due to the poor prognosis. Palliative treatment is frequently required to alleviate symptoms and potentially prevent complications. The current choice for stenting is either self-expandable metal stents (SEMS) or plastic stents (PS). Although plastic stents are cheaper, metal stents have shown to have better drainage and longer patency, which make them more cost effective. Several studies have compared the efficacy of PS and SEMS in patients with distal malignant biliary strictures and several others in hilar strictures. Aim: to detect clinically significant difference between SEMS and PS in both distal and hilar malignant biliary stricture on drainage, patency duration, survival and number of re-intervention. METHOD: We searched Pubmed, Embase and Cochrane databases for studies that provided data about malignant biliary obstruction and stents. We included randomized controlled trials (RCTs). Two reviewers selected the studies and disagreement was solved by a third. Quality for each included study was assessed by CONSORT system. Heterogeneity of the studies was analyzed by Cochran’s Q statistics. Mantel Haenszel Relative Risk and mean differences were calculated with fixed or random effect model to combine studies. Results: Seventeen studies involving 1437 patients (750 SEMS and 687 PSs) were included. Our meta-analysis confirmed that SEMS is associated with a significantly lower risk of occlusion rate 22% compared to 40% in PS (RR: 0.56, CI: 0.470.66). Therapeutic failure, defined as the lack of resolution of symptoms post stenting, was more likely when using PS 16% compared to SEMS 9% (RR: 0.57, CI: 0.42-0.77). Patients who received SEMS had a higher mean survival than PS with mean advantage of 41.46 days with SEMS (CI: 8.71-74.2, P 0.01). There was a trend toward lower 30 days mortality with SEMS compared to PS (13% Vs 16%, respectively) (RR: 0.78, CI: 0.57-1.06, P: 0.11). Stent migration was much less likely to occur with the use of SEMS 2% versus PS 7% (RR: 0.38, CI: 0.15-0.98). Patients who had SEMS required much less re-intervention compared to those who had PS (mean difference -0.71, CI: -.89 - -0. 53). The incidence of cholangitis was also significantly decreased SEMS group 11%vs, 17%;RR: 0.67, 95%CI: 0.48-0.94). Conclusion: SEMS used in the treatment of malignant biliary obstruction is associated with significantly lower occlusion rate, stent migration, therapeutic failure, need for re-intervention, and incidence of cholangitis.

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Abstracts Table 1. Characteristics and outcomes of FCSEMS in BBS

Diagnosis - Post transplant - Post cholecystectomy - Ischemic Oriental cholangitis - Chronic pancreatitis - Stricture with stone(s) - Other Bismuth - I - II - III - IV Duration (days) Success rate Migration rate - Total - With stent lock - Without stent lock

Hilar (N[10)

Non-Hilar (N [ 9)

P-value

2322001

2100222

NA

0118 135 60% 50% 0/3 (0%) 5/7 (71.4%)

9000 102 100% 44.4%

NA 0.627 0.033 0.809 0.038*

*between with and without stent lock

Su1623 Endoscopic Bilateral Stent-in-Stent Placement for Malignant Hilar Obstruction Using a Large Cell Type Stent Jin Myung Park*, Sang Hyub Lee, Kwang Hyun Chung, Jae MIN Lee, Ji Kon Ryu, Yong-Tae Kim Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea Background and Aims: Biliary self-expandable metal stent (SEMS) insertion is effective for palliation of unresectable malignant hilar obstruction. But bilateral stent-instent placement may be technically challenging. We performed this study to assess the technical success and clinical effectiveness of this technique with Niti-S large cell D-type biliary stent (LCD stent, Taewoong). Patients and Methods: The patients who underwent bilateral stent-in-stent placement using LCD stent were retrospectively reviewed in Seoul National College of Medicine. All patients showed malignant hilar obstruction (Bismuth type II, III, IV). Only procedures done by one endoscopist were analyzed to reduce the influence of inter-endoscopist difference. Results: Bilateral stent-in-stent placement was attempted in 33 patients between December 2011 and July 2013. Mean age was 66 years, and 18 patients were male. Most patients were diagnosed as hilar cholangiocarcinoma (21/33, 63.6%), gallbladder cancer (8/ 33,24.2%), and the others (4/33, 12.2%) were metastasis cases. Technical success rate was 75.8% with LCD stent (25/33). The 1st stent insertion was successful in all cases, but the guidewire could not be inserted into the contralateral side via the mesh of the 1st stent in 2 cases. In 6 cases the 2nd stent could not be passed via the mesh of the 1st stent. Different types of stents could be advanced via the mesh of the 1st stent for 3 of them. Finally bilateral stent-in-stent placement was technically successful in 84.8% of patients (28/33). Functional success was achieved in 88.0% of patients who were technically successful cases with only LCD stent (22/25). Median stent patency was 277 days. Procedure related complication occurred in 30.3% (10/ 33). Conclustions: Bilateral stent-in-stent placement by using a large cell type SEMS is technically and clinically considerable for palliation of malignant hilar obstruction.

Su1624 Biliary Stenting for Benign and Malignant Hilar Biliary Obstruction Using Very Long Multi-Sidehole Soft Plastic Stents: a 5-Year Experience From a Single Center Tossapol Kerdsirichairat*, Rajeev Attam, Mustafa a. Arain, Martin L. Freeman University of Minnesota, Minneapolis, MN Background: Conventional polyethylene plastic stents are associated with high rates of occlusion, migration and cholangitis when used for hilar stenoses. Alternative stents which are very long, pliable, and have multiple sideholes are available for use in the pancreas, and may be well suited to hilar strictures. We report our experience using such stents for hilar strictures. Methods: JohlinÒ pancreatic wedge stents are soft stents made of PellethaneÒ, fenestrated with multiple large sideholes, 8.5 Fr and 10 Fr, up to 22 cm in length. 20cm stents were used for left hepatic duct, resulting in approximately half the stent above and half below the hilum; stents were trimmed to a shorter length for right anterior and posterior sectoral ducts. Patients undergoing stenting for benign and malignant hilar strictures between 1/2009-5/2013 using one or more JohlinÒ stents were included. Baseline parameters included age, gender, indication of initial stenting (malignant vs benign hilar and/or intrahepatic biliary obstruction), and presence of prior indwelling stenting. Procedural data analysis included size and length of stents used, average duration of stent placement, interval placement of other stents between JohlinÒ stents, stent migration, significant improvement of cholangiogram and biliary drainage, and complications. Results: One or more JohlinÒ stents were inserted in 261 ERCPs in 97 patients (pt)(8.5 Fr in 63 ERCPs / 10 Fr in 217 ERCPs). Stents were single in 140, multiple

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in 77. Strictures were benign in 59 pts (post liver transplant anastomotic stricture [25], ischemic stricture [12], primary sclerosing cholangitis [5], post cholecystectomy [4]). Strictures were malignant in 38 pt (cholangiocarcinoma [20], hepatocellular carcinoma [3 ], metastatic cancer [ 15]). Median stent length, duration, overall complications are shown in Table 1. Complications occurred in 10/261 (3.8%). Early complications (! 1 week) occurred in one pt (post-ERCP pancreatitis). Late complications (O 1 week) included stent occlusion causing cholangitis in 9 pt (median of 3 weeks, IQR 2-6 weeks). 95 of 97 (98%) pt had follow-up to evaluate for stent migration. No stent migration occurred after 252/261 ERCPs (96.5%); proximal migration into the bile duct occurred in 3/261 ERCPs (1.1%); partial distal migration into the lumen in 6 (2.3%) without clinical consequence. All were easily retrieved without complications. 39/97 deaths identified, of which 24/39 were from malignant obstruction at median of 8 weeks (IQR 3-22) after initial JohlinÒ stent. Conclusions: Use of JohlinÒ stents for long-term biliary stenting is a feasible and safe option for benign and malignant hilar biliary obstruction. Advantages of these stents appear to be related to extreme length and flexibility, large diameter, and presence of multiple large side-holes which minimize migration and occlusion.

Table 1. Stent size, length, duration, and complications of Johlinâ stent placement for hilar biliary obstruction Stent diameter Median stent length Median stent duration Complications 8.5 Fr (nZ63) 10 Fr (nZ217)

16 (12-20 cm) 18 (9-20 cm)

4 weeks (IQR3-7) 5 weeks (IQR 3-7)

1/63 (1.6%) 9/217 (4.1%)

Su1625 Y-Shaped Bilateral Self Expandable Metallic Stent Placement (Stent-in-Stent Technique) for Malignant Hilar Biliary Obstruction: Data From a Large Saries of Patients Treated in a Tertiary Referral Center Roberto Di Mitri*, Filippo Mocciaro, Sandro Sferrazza, Rosalba Orlando Gastroenterology and Endoscopy unit, ARNAS Civico-Di CristinaBenfratelli Hospital, Palermo, Italy Introduction: Malignant hilar strictures (MHS) are a clinical challenge. Self expandable metallic stents (SEMS) have proven more effective than plastic stents for palliation of MHS registering a high success rate. Aims and Methods: We report data from a large series of patients treated with the "stent-in-stent" technique. From Apr. 2009 to Nov. 2013 we prospectively treated 22 consecutive patients with unrespectable MHS performing endoscopic bilateral stent-in-stent deployment (Niti-S Biliary Y stent; TaeWoong, Seoul, Korea). The first uncovered SEMS, with a central wide-open mesh, was placed across the hilar stricture (if needed balloon dilation was performed), afterwards the guidewire was withdrawn slowly and was inserted under fluoroscopic guidance into the central wide-open mesh identified by radiopaque markers. The second uncovered SEMS was so placed through the central crossed mesh of the primary stent (Y-shaped configuration). Results: Ten male and 12 female were treated (mean age 64.915.7 years): 10 had a cholangiocarcinoma (46%), 6 a metastatic colon cancer (27%), 4 a metastatic pancreatic cancer (18%), 2 a hepatocarcinoma (9%). The types of MHS according to the Bismuth classification were II in 5 patients (23%), IIIa in 1 (4%), and IV in 16 (73%). The mean bilirubin level was 15.14.8 mg/dL. Technical success (outflow of contrast medium and/or bile through the stents) was achieved in all patients with a significant reduction in bilirubin levels (2.91.8 mg/dL); 54% [12/22] patients were treated with balloon dilation before stent placement. One patient experienced cholangitis as early complication (!30 days) while in 2, at 3 and 10 months respectively, SEMS ingrowth was observed (occlusion were managed with the insertion of a plastic stent or a new SEMS through the occluded stent). No SEMS migration or other complications were recorded. At the end of the follow-up (mean 7.43.3 months) 15 out of 22 patients (68%) died. Conclusions: Our experience confirms as endoscopic bilateral SEMS placement with stent-in-stent technique (Y-shaped configuration) is a feasible, effective, and safe procedure for palliation of unresectable MHS.

Su1626 Metal or Plastic Stent for Hilar Duct Obstruction in Unresectable Gallbladder Cancer? Dao-Jian Gao*, Bing Hu, Tian-Tian Wang, Jun Wu, Xin Ye, Xiao-Ming Yang Department of Endoscopy, Eastern Hepatobiliary Hospital, The Second Military Medical University, Shanghai, China Background: Most of patients with gallbladder cancer(GC) presenting with jaundice are considered unresectable. Endoscopic endoprosthesis is the first-line palliative treatment. The metal stent is associated with a longer stent patency than plastic stent. However stent patency and patient survival may differ depending on the causative disease and type of stent. Previous reports regarding biliary stenting pooled various types of malignancy together. So far there are no data concerning

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