Long Slimmer Metal Stent Is Feasible and Effective for Endoscopic Dual Stent-by-Stent Placement in Malignant Hilar Biliary Stricture.

BACKGROUND: Bilateral endoscopic biliary stenting remains technically challenging, which limits its wider clinical application. AIMS: We have developed a novel long (10-12 cm) and slimmer (6 mm) self-expanded metal stent. The aim of this study was to evaluate the feasibility, efficacy, and safety of the new metal stent for palliative treatment of malignant hilar biliary strictures (MHBS). METHODS: This retrospective study of prospectively collected data included 45 patients with unresectable malignant hilar biliary strictures of Bismuth type II or higher. A pair of long slimmer metal stents were sequentially placed into the intrahepatic duct using the stent-by-stent mode. The success rate and short- and long-term clinical outcomes were observed. RESULTS: The technical success rate was 100%, with a mean procedure time of 43.7 ± 11.5 min. The clinical success was achieved in 44 patients (97.8%). Early adverse events included mild acute pancreatitis (n = 2) and cholangitis (n = 3). Later cholangitis occurred in 14 of the 45 patients due to stent occlusions. The median stent patency was 260 days (95% CI 228.3-291.7). Stent malfunctions occurred in 23 of the 45 patients, and 15 of them received bilateral endoscopic plastic stents placements. The technical success for the re-intervention was 100% with the mean procedure time of 24.3 ± 4.5 min. The median overall survival of the whole group was 229 days (95% CI 171.2-286.8). CONCLUSIONS: The long slimmer metal stent for bilateral endoscopic stent-by-stent placement proved to be safe, feasible, and effective for MHBS and facilitates endoscopic re-intervention as well.

Effect of endoscopic radiofrequency ablation on the survival of patients with inoperable malignant biliary strictures: A large cohort study.

BACKGROUND AND AIMS: Endoscopic radiofrequency ablation (RFA) is an emerging technique for the palliation of inoperable malignant biliary strictures (MBSs). We aimed to systemically investigate the long-term outcome of RFA in a large cohort of patients. METHODS: We recruited 883 patients with various MBSs who underwent endoscopic interventions at two large-volume centers; 124 patients underwent RFA and stenting, whereas 759 underwent stenting alone. To overcome selection bias, we performed 1:4 propensity score matching (PSM). The main outcome was overall survival (OS). RESULTS: Following PSM, patients in the RFA group showed significantly longer OS (9.5 months; 95% CI: 7.7-11.3 months) than those in the stenting alone group (6.1 months; 95% CI: 5.6-6.6 months; P < .001). In stratified analyses, the improved OS was only demonstrated in the subgroup of extrahepatic cholangiocarcinoma (11.3 months 95% CI: 10.2-12.4 vs 6.9 months 95% CI: 6.0-7.8; P < .001), but not in the subgroups of gallbladder cancer, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, pancreatic cancer, and other metastatic cancers (all P > .05). The survival benefits were noted only in the patients with non-metastatic cholangiocarcinoma (11.5 vs 7.4 months, P < .001). CONCLUSIONS: The survival benefits of endoscopic RFA appear to be limited to patients with extrahepatic cholangiocarcinoma without distant metastasis.

Endoscopic radiofrequency ablation may improve overall survival in patients with inoperable ampullary carcinoma.

OBJECTIVES: Patients with advanced ampullary carcinoma (AC) who are unsuitable for surgery are most likely to have poor outcomes. The role of endoscopic radiofrequency ablation (RFA) in this population has not been fully defined. We aimed to assess the short- and long-term outcomes of RFA in a large cohort of AC patients. METHODS: In this retrospective study, data of consecutive patients with pathologically proven AC who underwent successful endobiliary RFA and/or stent placement were collected. All patients did not undergo surgical resection. The primary outcome was overall survival (OS). The secondary outcomes included clinical success and adverse events. RESULTS: A total of 85 patients, 50 in the RFA plus stenting group and 35 in the stenting alone group, were identified. The median OS was significantly longer in the RFA group than in the stenting alone group (16.9 vs. 9.8 months, P < 0.001). In multivariable Cox analysis, RFA (hazards ratio 0.408; 95% confidence interval 0.235-0.706; P = 0.001) was the only independent OS predictor. Eight patients with stage II tumors, exclusively from the RFA group, survived for more than 3 years. Clinical success was comparable between the two groups (96% vs. 100%, P = 0.231). Early adverse events between the two groups were similar (10% vs. 2.9%, P = 0.206); however, late biliary/pancreatic stenoses occurred in three RFA patients who were successfully managed with endoscopic interventions. CONCLUSIONS: Endoscopic RFA appears to prolong patients' survival with acceptable safety; it may therefore be a feasible treatment option for patients with inoperable ampullary cancers.

Urgent Endoscopy Improves Hemostasis in Patients With Upper Gastrointestinal Bleeding Following Biliary-pancreatic Surgery: A Retrospective Analysis.

BACKGROUND: Upper gastrointestinal bleeding (UGIB) is a lethal complication of biliary-pancreatic surgery (BPS). The role of endoscopic intervention has not been fully defined in such a critical condition. The aim of this study was to assess the efficacy and safety of endoscopic hemostasis in a retrospective cohort. MATERIALS AND METHODS: Consecutive patients with acute UGIB after BPS who received interventional endoscopy between January 2007 and August 2020 were included in this study. The clinical characteristics were collected and analyzed to screen for predictive factors significantly associated with successful hemostasis. RESULTS: Among 37,772 patients who underwent BPS, 26 patients (0.069%) developed acute UGIB. The sites and causes of hemorrhage were as follows: gastroenteric anastomoe (n=17), gastric stump (n=2), jejunal anastomose (n=1), duodenal bulb ulcer (n=2), pancreatojejunal anastomosis hemorrhage (n=1), cholangiojejunal anastomose (n=1), gastroenteric anastomose and gastric stump hemorrhage (n=1), and Dieulafoy lesion (n=1). Successful endoscopic hemostasis was achieved in 19 (73.1%) of the 26 UGIB patients. In the 7 patients who failed endotherapy, 1 patient received a successful radiologic intervention, 6 patients underwent reoperation and achieved hemostasis in 4, and the other 2 patients died after reoperation. Logistic regression analysis showed that presentation-to-endoscopy time (≤12 h) was the only independent predictive factor associated with successful endoscopic hemostasis. CONCLUSIONS: Endoscopic hemostasis is relatively safe and effective in controlling UIGB after BPS. Prompt intervention (≤12 h) could improve the success rate of endoscopic hemostasis.

Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial.

BACKGROUND AND AIMS: We sought to compare the efficacy and safety between endoscopic radiofrequency ablation (RFA) and stent placement alone in patients with unresectable extrahepatic biliary cancer (EBC). METHODS: In this randomized controlled trial, patients with locally advanced or metastatic cholangiocarcinoma (CCA) or ampullary cancer who were unsuitable for surgery were recruited from 3 tertiary centers. Eligible patients were randomly assigned to RFA plus plastic stent placement (RFA group) or plastic stent placement alone (stent placement alone group) in a 1:1 ratio. Both groups underwent 2 scheduled interventions with an interval of approximately 3 months. The primary outcome was overall survival (OS). RESULTS: Altogether, 174 participants completed the 2 index endoscopic interventions. No significant differences in baseline characteristics were noted between the 2 groups. The median OS was significantly higher in the RFA group (14.3 vs 9.2 months; hazard ratio, .488; 95% confidence interval, .351-.678; P < .001). A survival benefit was also shown in patients with CCA (13.3 vs 9.2 months; hazard ratio, .546; 95% confidence interval, .386-.771; P < .001). However, no significant between-group differences were found in jaundice control or stent patency duration. The postprocedural Karnofsky performance scores were significantly higher in the RFA group until 9 months (all P < .001). Adverse events were comparable between the 2 groups (27.6% vs 19.5%, P = .211), except for acute cholecystitis, which was more frequently observed in the RFA group (9 vs 0, P = .003). CONCLUSIONS: Compared with stent placement alone, additional RFA may improve OS and quality of life of patients with inoperable primary EBC who do not undergo systemic treatments. (Clinical trial registration number: NCT01844245.).

Comparison of endoscopic bilateral metal stent drainage with plastic stents in the palliation of unresectable hilar biliary malignant strictures: Large multicenter study.

BACKGROUND: Endoscopic stenting to manage malignant hilar biliary obstruction has no consensus regarding the optimal stenting strategy. In this multicenter study, we compared transpapillary parallel-style bilateral metal stenting with bilateral plastic stenting, and evaluated short- and long-term outcomes. METHODS: We recruited 262 consecutive patients (Bismuth classification types II-IV) who underwent either bilateral metal or plastic stenting as primary therapy at four tertiary centers. To overcome selection bias, we performed 1:1 propensity score matching. Our primary outcome was overall survival. RESULTS: After propensity score matching, each group comprised 96 patients, with no significant differences in any baseline characteristics. The median survival was significantly longer in the metal stenting group than in the plastic stenting group (7.2 months [95% CI 6.0-8.5] vs. 4.1 months [95% CI 2.9-5.3]; P = 0.015). The clinical success rates were significantly higher in the metal stenting group than in the plastic stenting group (99.0% vs. 71.9%, respectively; P < 0.001), and lower post-procedure cholangitis incidence (7.3% vs. 26.0%; P < 0.001), longer median symptom-free stent patency (9.2 months [95% CI 7.6-10.6] vs. 4.8 months [95% CI 4.2-5.3]; P < 0.001), and fewer total interventions (1.3 ± 0.6 vs. 2.0 ± 1.4; P < 0.001). In multivariate Cox analysis of the overall survival, metal stenting (HR 0.589, P = 0.002), hilar cholangiocarcinoma (HR 0.419, P = 0.009), and adjuvant treatment (HR 0.596, P = 0.006) were independent predictors of death. CONCLUSIONS: Endoscopic therapy using bilateral metal stenting is superior to bilateral plastic stenting, with prolonged overall survival, higher clinical success, and longer stent patency in patients with advanced hilar biliary malignancies.

Establishment of a Swine Benign Biliary Stricture Model of Endobiliary Thermal Injury With a Diathermic Sheath.

BACKGROUND: A reliable large animal model of benign biliary stricture (BBS) is essential to study endoscopic management of BBS. The aim of this study was to establish a swine BBS model of endobiliary electrothermal injury with a diathermic sheath and screen out the optimal energy dose. MATERIALS AND METHODS: Twelve swine were equally randomized into a low (20 W), a medium (30 W), and a high (40 W)-dose group. Endobiliary electrothermal injury was applied to the common bile duct using a diathermic sheath at different energy doses for 20 seconds via endoscopic retrograde cholangiopancreatography. Cholangiographic findings and liver function were evaluated weekly after thermal injury. Two animals from each group were sacrificed at 2 weeks and the other 2 sacrificed 4 weeks after thermal injury for histopathologic evaluation. RESULTS: BBS was established successfully in 10 of the 12 animals. Two of the 4 animals in low-dose group did not produce biliary stricture at 4 weeks; in medium-dose group, BBS was induced in both animals at 2 weeks without causing severe complications; and in high-dose group, BBS was produced in 4 animals at 2 weeks, causing perforation and abdominal abscess formation in 1 animal. CONCLUSIONS: A safe and reproducible swine model of BBS could be established successfully by applying endobiliary electrothermal injury with a diathermic sheath at 30 W for 20 seconds.

Optimal stent placement strategy for malignant hilar biliary obstruction: a large multicenter parallel study.

BACKGROUND AND AIMS: The endoscopic management of malignant hilar biliary obstruction (MHBO) remains extremely challenging without universal consensus. For the first time, we compared 4 major modalities aiming to determine the optimal strategy. METHODS: We reviewed 1239 patients with advanced MHBO who underwent endoscopic stent placement as the primary treatment in 4 tertiary centers. Among them, 633 eligible patients were identified and classified into 4 groups: bilateral metal stent placement (BMS), unilateral metal stent placement (UMS), bilateral plastic stent placement (BPS), and unilateral plastic stent placement (UPS). The outcomes were compared before and after propensity score matching (PSM). RESULTS: After PSM, 87, 97, 91, and 81 patients in the BMS, UMS, BPS, and UPS groups, respectively, were matched. The clinical success rates were 98.9%, 83.5%, 71.4%, and 65.4% in the BMS, UMS, BPS, and UPS groups (P < .001), respectively. The postprocedural cholangitis rates were 8.0%, 17.5%, 26.4%, and 29.6% (P = .002), respectively. The median symptom-free stent patency was 9.6, 6.8, 4.6, and 4.2 months (P < .001), respectively. The mean number of interventions required was 1.2 ± 0.5, 1.7 ± 0.8, 2.0 ± 1.4, and 1.9 ± 1.3 (P < .001), respectively. The median (95% confidence interval) overall survival (OS) was 7.1 (6.0-8.2), 4.4 (3.8-4.9), 4.1 (2.9-5.2), and 2.7 (1.8-3.7) months (P = .001), respectively. Compared with plastic stent placement, metal stent placement achieved higher success in all outcome parameters (P ≤ .001). Bilateral stent placement was superior to unilateral stent placement in terms of clinical success (P = .024), stent patency (P = .018), and OS (P = .040). CONCLUSIONS: If technically possible, dual metal stent placement is a preferred palliation for inoperable MHBO, and unilateral metal stent placement is the second option.

Initial Experience of ERCP-Guided Radiofrequency Ablation as the Primary Therapy for Inoperable Ampullary Carcinomas.

BACKGROUND: Endoscopic ablation of duodenal ampullary malignancy has not been fully assessed. AIMS: The study aimed to evaluate the efficacy and safety of Endoscopic retrograde cholangiopancreatograpy (ERCP)-guided radiofrequency ablation (RFA) for inoperable ampullary cancer. METHODS: Patients with inoperable ampullary cancer underwent ERCP-guided RFA from January 2012 to August 2017. RF energy (7-10 W) was delivered using bipolar RFA electrodes under endoscopic guidance. RFAs were repeated every 1-3 months until visible tumor was eliminated. All patients were followed up till June 2018, during which any biliary event was noted and managed endoscopically. RESULTS: Twenty-three patients underwent a median of two RFA sessions (range 1-6) at a median interval of 56 (range 35-90) days. Among 18 (78.3%) patients who received endoscopic re-evaluations, nine patients showed no remaining lesion and nine showed more than 50% tumor size reduction. During a median follow-up duration of 517 days (range 60-1836 days), eight (34.8%) patients required endoscopic re-interventions. The re-intervention rate at 6 months after RFA was 36.8%. Twelve patients were alive, among whom six required no biliary stenting. The accumulative mean survival was 1081 (95% CI 757.8-1404.0) days. RFA-related adverse events occurred in four cases (7.7%) including mild pancreatitis (1), bleeding (1), and late distal biliary stenosis (2). CONCLUSION: This pilot study shows that ERCP-guided RFA is safe to use and able to reduce tumor volume and re-interventions in patients with inoperable ampullary cancer.

The risk of acute cholangitis after endoscopic stenting for malignant hilar strictures: A large comprehensive study.

BACKGROUND AND AIM: Endoscopic stenting for unresectable malignant hilar biliary strictures (MHBS) remains challenging. Post-endoscopic retrograde cholangiopancreatography cholangitis (PEC) can be the most common and fatal adverse event. In the present study, we aimed to systematically evaluate the incidence, severity, risk factors, and consequences of PEC after endoscopic procedures for advanced MHBS. METHODS: Of 924 patients, we identified 502 patients with MHBS (Bismuth types II to IV) who underwent endoscopic stenting as the primary therapy at two centers over 16 years. PEC and its severity were verified according to the current Tokyo guidelines. RESULTS: A total of 108 patients (21.5%) experienced acute PEC. Mild, moderate, and severe cholangitis were encountered in 51 (10.1%), 42 (8.4%), and 15 (3.0%) patients, respectively. Multivariate analyses showed that metal stenting (verse plastic stenting) (OR 0.328, 95% CI 0.200-0.535, P < 0.001) and Bismuth classification (IV vs III/II) (OR 2.499, 95% CI 1.150-5.430) were independent predictors for PEC and the moderate/severe type. Patients with PEC had significantly lower clinical success rates (86.3% vs 41.7%, P < 0.001), a higher rate of early death (6.5% vs 0.5%, P < 0.001), a shorter median stent patency (4.9 vs 6.4 months, P < 0.001), and shorter overall survival (2.6 vs 5.2 months, P < 0.001) compared with the noncholangitis group. CONCLUSIONS: After endoscopic stenting for advanced MHBS, cholangitis may occur in as many as 21.5% of patients, which may be associated with a poor prognosis. The risk is high in patients with Bismuth type IV and may be reduced by using metal stents.

Congested bile can predict the outcomes of endoscopic stenting for hilar biliary malignancies.

OBJECTIVE: Endoscopic management of malignant hilar biliary obstruction (MHBO) remains challenging, with relatively poor jaundice control and high infectious risk. The factors that affect the outcome of endoscopic therapy are still unclear. This retrospective cohort study aimed to investigate predictive factors for the outcomes of biliary stenting in patients with MHBO. METHODS: Between June 2015 and June 2016, consecutive patients with MHBO who received primary endoscopic stenting and completed follow-up at our institution were identified and evaluated. All patients received full aspiration of congested bile followed by plastic or metal stent(s) placement. Clinical success was achieved in patients whose total serum bilirubin decreased by over two-thirds in a month. RESULTS: A total of 64 patients were included. Among them, 28 received a single stent placement and 36 received multiple stent placements. Altogether 53 (82.8%) patients attained clinical success and 48 (75.0%) underwent re-interventions within 6 months. Multivariate analyses showed that only a total bile volume of ≥30 mL aspirated from the intrahepatic ducts predicted clinical success (OR 6.83, 95% CI 1.2-38.4, P = 0.029), absence of early post-endoscopic retrograde cholangiopancreatography cholangitis (OR 0.03, 95% CI 0.004-0.36, P = 0.001), and lack of re-intervention within 6 months (HR 0.10, 95% CI 0.05-0.22, P < 0.001) after initial endoscopic stenting. CONCLUSION: The volume of congested bile may effectively predict treatment outcomes of endoscopic stenting for MHBO and guide the therapeutic strategy.

A New Fully Covered Self-Expandable Metal Stent for the Treatment of Postsurgical Benign Biliary Strictures.

BACKGROUND: Endotherapy with plastic stent (PS) placement is the main modality for treating benign biliary strictures (BBSs). Fully covered self-expandable metal stents (FCSEMSs) are being increasingly used for BBS management, with high stricture resolution. However, traditional metal tents are associated with high migration, causing treatment failure. METHODS: We investigated the efficacy and safety of a new FCSEMS for postsurgical BBS treatment and compared these parameters between the FCSEMS and PS treatment through retrospective analysis. The primary outcome measurements included stricture resolution, stricture recurrence, and complications. RESULTS: In total, 69 patients were included, of whom 32 underwent FCSEMS treatment and 37 underwent PS treatment. The technical success rate and the number of endoscopic retrograde cholangiopancreatography procedures were similar between the groups. The median stenting duration was 5.2 months (range 1.5-15.3) in the FCSEMS group and 10.7 months (range 2.5-22.6) in the PS group (P < 0.01). The stents removal rate was 96.9% in the FCSEMS group and 94.6% in the PS group. The stricture resolution rate based on intention-to-treat analysis was 83.8% in the PS group and 84.4% (27/32) in the FCSEMS group (P = 0.947), whereas the rates from per-protocol analysis were 88.6% (31/35) and 87.1% (27/31), respectively (P = 0.574). Early and late complications were similar between the groups. The median follow-up time was 43 months (range 13-71). The stricture recurrence rate was 11.1% (3/27) in the FCSEMS group and 16.1% (5/31) in the PS group (P = 0.435). CONCLUSIONS: The new FCSEMS and the PS approach showed similar efficacy and safety in postsurgical BBS treatment. However, the FCSEMS required fewer procedural steps and shorter stenting time, making it an effective alternative modality.

Clinical outcome of endoscopic covered metal stenting for resolution of benign biliary stricture: Systematic review and meta-analysis.

BACKGROUND AND AIM: Management of benign biliary stricture is challenging. Endoscopic therapy has evolved as the first-line treatment for various benign biliary strictures. However, covered self-expandable metal stents (CSEMS) have not been approved by the United States Food and Drug Administration for the treatment of benign biliary stricture. With this goal, we conducted the present systemic review and meta-analysis to evaluate the efficacy and safety of endoscopic stenting with CSEMS in the treatment of benign biliary stricture. METHODS: Systematic review and meta-analysis by searching PubMed, MEDLINE and Embase databases. RESULTS: In total, 37 studies (1677 patients) fulfilled the inclusion criteria. Pooled stricture resolutions were achieved in 83% of cases. Median stent dwelling time was 4.4 months, with median endoscopic retrograde cholangiopancreatography sessions of 2.0. Stricture recurrence at 4-year follow up was 11% (95% CI, 8-14%). Pooled complication rate was 23% (95% CI, 20-26%). CONCLUSIONS: Placement of CSEMS is effective in the treatment of benign biliary stricture with relatively short stenting duration and low long-term stricture recurrence rate. However, more prospectively randomized studies are required to confirm the results.

Metal versus plastic stents for unresectable gallbladder cancer with hilar duct obstruction.

BACKGROUND AND AIM: Metal stents usually have a longer stent patency than plastic stents for malignant biliary obstruction. However, stent patency and patient survival may differ depending on the causative disease and stent type. There are no data regarding the selection of stents for unresectable gallbladder cancer (GC) with hilar duct obstruction. The aim of the present study was to evaluate the efficacy of metal versus plastic stents for unresectable GC with hilar duct obstruction. METHODS: Fifty-nine unresectable GC patients with jaundice were divided into metal stent group (MSG) and plastic stent group (PSG) depending on stent deployment. Clinical outcomes and approximate costs were assessed retrospectively. RESULTS: No significant difference was found between MSG (n = 28) and PSG (n = 31) for clinical success, early adverse events and later cholangitis. Median patency and survival were 119 and 112 days in MSG versus 93 and 118 days in PSG, respectively (P > 0.05). However, the overall cost was higher in MSG than in PSG (P = 0.00). Cox proportional hazards model analysis showed that the lower Bismuth type was associated with a longer stent patency (P = 0.046), whereas older age (P = 0.041) and lower TNM stage (P = 0.002) were associated with longer survival. CONCLUSION: Although metal and plastic stents have similar clinical efficacy, it seems reasonable to choose plastic stents as the treatment of choice for unresectable GC when cost-effectiveness is taken into account.

Endoscopic radiofrequency ablation may be preferable in the management of malignant biliary obstruction: A systematic review and meta-analysis.

OBJECTIVE: Endoscopic biliary radiofrequency ablation (RFA) has been increasingly used to treat unresectable malignant biliary obstruction (MBO). We aimed to perform this systematic review and meta-analysis to evaluate the efficacy and safety for the treatment of malignant biliary obstruction (MBO) and its impact on patient's survival. METHODS: A comprehensive search of the Cochrane Library, PubMed and EMBASE databases was conducted. A meta-analysis was performed by extracting the data from the included studies with regard to technical effectiveness, overall survival, adverse events and mortality of endoscopic RFA. RESULTS: A total of nine studies comprising 263 patients with MBO were included in the analysis. There was a significant increase in the diameter of stricture (3.446 mm, 95% confidence interval [CI] 3.356-3.536 mm) after the endoscopic biliary RFA. The overall survival time was 9.62 months, with pooled 30-day, 90-day and 2-year mortality rates of 2% (95% CI 0.5-5.9%), 21% (95% CI 5-37%), and 48% (95% CI 37-59%), respectively. The pooled rate of adverse events was 17% (95% CI 10-25%), and most complications were mild and managed conservatively. Severe adverse events occurred in three patients (two deaths due to hemobilia and one with partial liver infarction). CONCLUSIONS: Endoscopic biliary RFA is effective and generally safe in the management of unresectable biliary malignancies, and may improve patients' overall survival. Prospective, randomized controlled studies are required to further support the results.

Management of benign biliary strictures with a novel retrievable self-expandable metal stent.

OBJECTIVE: Endoscopic placement of covered self-expandable metal stent (SEMS) has gained popularity in the management of benign biliary strictures (BBS). The existing SEMS has been designed primarily to palliate malignant biliary obstruction and has a high frequency of stent migration, difficulty in retrieval and stricture recurrence after stent removal. This study aimed to design a novel retrievable SEMS dedicated to the treatment of extrahepatic BBS and evaluate its clinical efficacy and safety. METHODS: A short fully covered SEMS (FCSEMS) with a retrieval lasso was designed for the specific treatment of BBS. A total of 45 patients with segmental extrahepatic BBS were included in this study. The stent was placed entirely inside the bile duct with only the retrieval lasso extending from the papilla. The stents were recommended to be in situ for 6 to 12 months before removal. RESULTS: The FCSEMS was successfully placed in all 45 patients. In all, 33 patients had their FCSEMS successfully removed after a mean period of 8.6 ± 3.7 (range 2-15.5) months. Stent migration occurred in 9.1% of the patients. During a mean follow-up of 18.9 months after stent removal, recurrent stricture was found in 2 (6.1%) patients and was successfully treated with a second FCSEMS. Overall, the strictures resolved in 30/33 (90.9%) patients. CONCLUSIONS: Intraductal placement of a short FCSEMS is suitable for the treatment of segmental extrahepatic BBS. This new removable design offered prolonged stenting and drainage for BBS for up to one year with minimal complications.

Antireflux stents to reduce the risk of cholangitis in patients with malignant biliary strictures: a randomized trial.

BACKGROUND AND STUDY AIMS: There are limited data on the role of antireflux biliary stents. This single-center randomized trial compared the endoscopic use of partly covered antireflux metal stents (pcARMS) with that of standard uncovered self-expandable metal stents (ucSEMS) for the palliation of nonhilar malignant biliary obstruction. PATIENTS AND METHODS: Between August 2007 and February 2012, patients with nonhilar malignant biliary obstruction were randomly assigned to treatment with either pcARMS or ucSEMS. Subsequent follow-up was conducted in clinic or by phone. The primary outcome was onset of cholangitis within 12 months of stenting. Secondary outcomes included other morbidities, stent dysfunctions, and survival. RESULTS: Altogether 112 patients were included, 56 in each group. The stents were successfully deployed in all patients. Satisfactory jaundice control was achieved in 49 cases in the pcARMS group, compared with 47 in the ucSEMS group (P = 0.135). Fewer patients experienced cholangitis in the pcARMS group than in the ucSEMS group (10 vs. 21 patients; P = 0.035), and the frequency of episodes was less (P = 0.022). Respectively, 17 and 29 stent dysfunctions before death were observed in the pcARMS and ucSEMS groups (P = 0.051) and the median stent patency was 13.0 (standard deviation [SD] 3.4) and 10.0 (1.2) months, respectively (P = 0.044). At final follow-up, in January 2013, 50 /52 and 52 /55 patients had died and no difference in median survival was seen between the two groups (8.0 vs. 9.0 months, P = 0.56). CONCLUSIONS: Stenting with pcARMS compared with standard ucSEMS reduces risk of ascending cholangitis and has longer stent patency, but does not increase patient survival. Chictr.org. number, ChiCTR-TRC-11001800.

Intraductal radiofrequency ablation for refractory benign biliary stricture: pilot feasibility study.

BACKGROUND AND AIM: Endoscopic management of benign biliary stricture (BBS) remains challenging. There is no reported method for the amelioration of biliary fibroplasia endoscopically. We report our initial experience of radiofrequency ablation (RFA) for the management of BBS. METHODS: Nine patients with BBS (postoperation stricture four, liver transplant three, and chronic inflammation two), seven of whom had previously unsuccessful endoscopic or percutaneous interventions, were enrolled. Intraductal bipolar RFA was delivered at power of 10 W for 90 s per stricture segment, followed by balloon dilatation with/without stent placement. RESULTS: All patients had immediate stricture improvements after RFA. No severe adverse event occurred except for one patient with mild post-endoscopic retrograde cholangiopancreatography pancreatitis. During median (SD) follow-up duration of 12.6 (3.9) months, BBS resolution without the need for further stenting was achieved in four patients whereas two patients had stent(s) in situ waiting scheduled removal. However, one patient had stricture relapse after initial resolution, one underwent surgery, and another patient died of other cause. CONCLUSIONS: Endobiliary RFA appears to be safe and effective for the treatment of BBS, especially for refractory cases. Further studies are warranted.

Endotherapy versus surgery for early neoplasia in Barrett's esophagus: a meta-analysis.

BACKGROUND: Esophagectomy is the conventional treatment for Barrett's esophagus with high-grade dysplasia and intramucosal cancer. Endotherapy is an alternative treatment. OBJECTIVE: To compare the efficacy and safety of these 2 treatments. DESIGN: PubMed, Web of Science, EMBASE, Cochrane Library and momentous meeting abstracts were searched. Studies comparing endotherapy with esophagectomy were included in the meta-analysis. Pooling was conducted in a random-effects model. SETTING: Tertiary-care facility. PATIENTS: Seven studies involving 870 patients were included. INTERVENTION: Endotherapy and esophagectomy. MAIN OUTCOME MEASUREMENTS: Neoplasia remission rate, neoplasia recurrence rate, overall survival rate, neoplasia-related death, and major adverse events. RESULTS: Meta-analysis showed that there was no significant difference between endotherapy and esophagectomy in the neoplasia remission rate (relative risk [RR] 0.96; 95% CI, 0.91-1.01); overall survival rate at 1 year (RR 0.99; 95% CI, 0.94-1.03), 3 years (RR 1.03; 95% CI, 0.96-1.10), and 5 years (RR 1.00; 95% CI, 0.93-1.06); and neoplasia-related mortality (risk difference [RD] 0; 95% CI, -0.02 to 0.01). Endotherapy was associated with a higher neoplasia recurrence rate (RR 9.50; 95% CI, 3.26-27.75) and fewer major adverse events (RR 0.38; 95% CI, 0.20-0.73). LIMITATIONS: Relatively small number of retrospective studies available, different types of endoscopic treatments were used. CONCLUSION: Endotherapy and esophagectomy show similar efficacy except in the neoplasia recurrence rate, which is higher after endotherapy. Prospective, randomized, controlled trials are needed to confirm these results.

Feasibility of using wire-guided needle-knife electrocautery for refractory biliary and pancreatic strictures.

BACKGROUND: Endoscopic management of biliary or pancreatic strictures by stent insertion is well established. However, some high-grade strictures are refractory to dilation and stent placement with conventional methods. OBJECTIVE: To evaluate the safety and efficacy of the wire-guided electrotomy technique in dilating stiff biliary and/or pancreatic stenoses when ordinary methods failed. DESIGN: Retrospective analysis of a prospective database. SETTING: Tertiary referral university hospital. PATIENTS: This study involved 279 patients with biliary or pancreatic strictures who underwent ERCP for stenting. INTERVENTION: After conventional dilation failed, wire-guided needle-knife electrocautery was attempted to facilitate insertion of the dilating devices and eventually endoprosthesis. MAIN OUTCOME MEASUREMENTS: The successful treatment and drainage of biliary or pancreatic strictures. RESULTS: With wire-guided needle-knife cauterization, the success rate of stricture dilatation increased from 95.7% (267 of 279 patients) to 98.9% (276 of 279 patients). Dilation of stenoses was successful in 9 of 10 patients (90%) by using electrocautery with the wire-guided needle-knife technique. Postprocedure adverse events included self-limited bleeding, mild acute pancreatitis, hyperamylasemia, cholangitis, and biliary perforation. No procedure-related death occurred. LIMITATIONS: Retrospective, single-center study and small sample size. CONCLUSIONS: Wire-guided needle-knife electroincision appears to be effective for traversing refractory biliary or pancreatic strictures and can be considered as an alternative approach to conventional methods. However, the safety of such a technique needs to be further evaluated.