Recurrent Biliary Obstruction Research Articles

Comparison of recurrent biliary obstruction with the use of metal and plastic stents in EUS-guided biliary drainage: A propensity score-matched analysis.

In transpapillary biliary drainage, metal stents (MSs) exhibit a lower incidence of a biliary obstruction than plastic stents (PSs). However, few studies have compared recurrent biliary obstruction (RBO) when MSs and PSs are used in EUS-guided hepaticogastrostomy (EUS-HGS) and choledochoduodenostomy (EUS-CDS). We retrospectively evaluated the RBO for both stents in each procedure. : Between November 2012 and December 2020, 85 and 53 patients who underwent EUS-HGS and EUS-CDS for unresectable malignant biliary obstruction, respectively, were enrolled. Factors associated with RBO were assessed. Clinical outcomes were compared between the MS and PS groups using propensity score matching. : The clinical success rate and procedure-related adverse events were similar in the MS and PS groups. Multivariate analysis identified the use of PS as a factor associated with RBO (EUS-HGS, P = 0.03; EUS-CDS, P = 0.02). After matching, the median time to RBO in EUS-HGS (MS: 313; PS: 125 days; P = 0.01) in the MS group was longer than that in the PS group. The cumulative incidence of RBO at 1, 3, and 6 months in the MS group was significantly lower than that in the PS group for EUS-HGS (MS: 4.0%, 8.2%, and 8.2%; PS: 12.4%, 24.9%, and 39.5%, respectively, P = 0.01). : MS exhibited a lower rate of RBO than PS for EUS-HGS and EUS-CDS.

Optimal liver drainage rate for survival in patients with unresectable malignant hilar biliary obstruction using 3D-image volume analyzer.

Drainage exceeding 50% of total liver volume is a beneficial prognostic factor in patients with unresectable malignant hilar biliary obstruction (UMHBO). However, it is unclear what threshold percentage of total liver volume drained ('liver drainage rate') significantly improves survival in patients with UMHBO who received systemic chemotherapy. We aimed to assess the optimal liver drainage rate that improves survival in patients with UMHBO receiving chemotherapy using a three-dimensional (3D)-image volume analyzer. This study was a single-center retrospective cohort study. Data from 90 patients with UMHBO who received chemotherapy after endoscopic biliary drainage using metal stents at Okayama University Hospital from January 2003 to December 2020 were reviewed. The liver drainage rate was calculated by dividing the drained liver volume by the total liver volume using a 3D-image volume analyzer. The primary endpoint was overall survival by liver drainage rate. The secondary endpoints were time to recurrent biliary obstruction (TRBO) and prognostic factors. The median total liver volume was 1172 (range: 673-2032) mL, and the median liver drainage rate was 83% (range: 50-100). Overall survival was 376 (95% CI: 271-450) days, and patients with >80% drainage (n = 67) had significantly longer survival than those with <80% drainage (n = 23) (450 days versus 224 days, p = 0.0033, log-rank test). TRBO was 201 (95% CI: 155-327) days and did not differ significantly by liver drainage rate. Multivariate Cox proportional hazards regression analysis revealed >80% liver drainage [hazard ratio (HR): 0.35, 95% CI: 0.20-0.62, p = 0.0003] and hilar cholangiocarcinoma (HR: 0.30, 95% CI: 0.17-0.50, p < 0.0001) as significant prognostic factors. In patients with UMHBO scheduled for chemotherapy, >80% drainage is associated with improved survival. Further prospective multicenter studies are needed to verify the results of this study. Okayama University Hospital, IRB number: 2108-011.

Long-term outcomes of duckbill-type anti-reflux metal stents versus conventional covered metal stents in reinterventions after covered biliary metal stent dysfunction in unresectable pancreatic cancer.

The use of duckbill-type anti-reflux metal stents (DMS) in reinterventions after covered metal stent (CMS) dysfunction has been reported in patients with distal malignant biliary obstruction (MBO). However, the superiority of DMS over conventional CMS (c-CMS) has not been established. Therefore, we conducted this retrospective study to evaluate the long-term efficacy and safety of DMS as a second stent in comparison with c-CMS. We investigated consecutive patients with distal MBO due to unresectable pancreatic cancer who underwent reintervention after dysfunction of initial biliary CMS at our institution. We compared causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates of DMS and c-CMS in this stenting. A total of 76 patients were included (DMS 41 and c-CMS 35). While overall RBO rates were similar between the two groups (46% vs. 63%, p = 0.172), RBO due to non-occlusion cholangitis tended to be less frequent in the DMS group than in the c-CMS group (2% vs. 14%, p = 0.089). Median TRBO was significantly longer in the DMS group (286days vs. 112days, p = 0.029). DMS was identified as the only significant risk factor for TRBO (hazard ratio, 0.52; p = 0.044). Overall AE rates were significantly lower in the DMS group (2% vs. 23%, p = 0.010), with non-occlusion cholangitis being the most common AE in the c-CMS group. Endoscopic reintervention was successfully performed in all patients in both groups, despite failed stent removal in 15% of patients in DMS group. DMS was associated with a significantly longer TRBO and lower rate of AEs compared with c-CMS in reinterventions after initial CMS dysfunction. DMS may be preferable to c-CMS as a second stent after biliary CMS dysfunction.

Efficacy of a novel self-expandable metal stent with dumbbell-shaped flare ends for distal biliary obstruction due to unresectable pancreatic cancer

This study aimed to evaluate the efficacy of a novel fully covered self-expandable metal stent (SEMS) with dumbbell-shaped flare ends for the palliation of distal biliary obstruction (DBO) due to unresectable pancreatic cancer (UPC). Patients with DBO due to UPC who received the novel HILZO fully covered stent (HFS), the WALLFLEX partially covered stent (WPS) or fully covered stent (WFS) were analyzed. The incidence of recurrent biliary obstruction (RBO), time to RBO (TRBO), and the incidence of complications were compared among the three SEMS groups. Eighty-four patients (HFS, n = 36; WPS, n = 20; WFS, n = 28) were included. The incidence of RBO was low in the HFS group (versus the WPS and WFS group, p = 0.033 and 0.023, respectively). TRBO in the HFS group was longer than that in the WFS group (p = 0.049). Placement of the HFS was an independent factor for long TRBO in multivariable analysis (p = 0.040). The incidence of pancreatitis and cholecystitis in the HFS group was low (one for each). It is recommended to use the HFS for the palliation of DBO due to UPC from the viewpoint of the low incidence of RBO and complications.

In-stent radiofrequency ablation with uncovered metal stent placement for tumor ingrowth/overgrowth causing self-expandable metal stent occlusion in distal malignant biliary obstruction: multicenter propensity score–matched study

In patients with unresectable malignant biliary obstruction (MBO), endoscopic drainage with a self-expandable metal stent (SEMS) is a well-established treatment, but stent patency is limited. This study aimed to evaluate the efficacy of in-stent radiofrequency ablation (IS-RFA) followed by uncovered SEMS placement for the management of occluded SEMSs. From 2016 to 2020, 48 patients with recurrent biliary obstruction due to tumor ingrowth or overgrowth after SEMS placement for pancreatobiliary cancer in 3 tertiary hospitals were analyzed. For distal MBO, patients in the RFA group were treated with IS-RFA and uncovered SEMS placement, and those in the control group were treated with uncovered SEMS placement alone. Patients in both groups were matched on the basis of propensity scores in a 1:1 ratio. The median time to recurrent biliary obstruction (TRBO) was 117 days in the RFA group and 82.5 days in the control group (P= .029). No significant differences in median overall survival were detected between the 2 groups (170 days vs 72 days; P= .902). No significant adverse events were reported after the second SEMS placement in either group, but 2 cases of mild cholangitis were reported in the control group. Ablation was interrupted in 5 patients (35.7%) of the RFA group owing to in-stent contact, but sufficient ablative energy was delivered in the majority of the patients (92.9%) after IS-RFA was repeated in the same session. IS-RFA followed by an uncovered SEMS is safe and feasible and may improve TRBO as a stent revision for occluded SEMSs in pancreatobiliary cancer.

Modified hepaticocholecystoenterostomy technique for certain hepatobiliary and pancreatic diseases: Case series report by a single surgeon.

Prior to this research, very few reports of hepaticocholecystoenterostomy (HCE) and its modification have been published. Two anastomoses were used to establish a biliary bypass using the gallbladder as a conduit by a senior hepato-biliary surgeon. Between 2013 and 2019, 11 patients (five men and six women) with a mean age of 61.7±15.7 (range, 31-85) years were seen. Disease indications included periampullary malignant tumours of Vater (7 cases), chronic pancreatitis (1 patient), cystic pancreatic head tumours (2 patients), and choledochal cysts (1 patient). Pancreaticoduodenectomy, bypass, cholangiocarcinoma, and choledochal cystectomy were performed on 4, 4, 2, and 1 patients, respectively. Follow-up showed no jaundice at all with no recurrent biliary obstruction. HCE is both safe and effective in a subgroup of patients. This is a treatment of choice in some instances, such as a small common bile duct, a limited surgical field in the hilar area, or a difficult hepaticojejunostomy.

Endoscopic Ultrasound-Guided Hepaticogastrostomy with Antegrade Stenting Without Dilation Device Application for Malignant Distal Biliary Obstruction in Pancreatic Cancer.

Endoscopic ultrasound-guided hepaticogastrostomy with antegrade stenting (EUS-HGAS) is a promising therapeutic option for malignant distal biliary obstruction (MDBO) in the event of transpapillary approach failure. Eliminating the fistula dilation step may further decrease the incidence of adverse events (AE) and simplify the procedure. This study focused on MDBO associated with pancreatic cancer and aimed to examine the utility of EUS-HGAS without the use of any dilation devices. This retrospective study investigated consecutive patients in whom the transpapillary approach had failed or was difficult, and who underwent EUS-HGAS without dilation device usage, using a tapered small-diameter catheter, ultrathin delivery system, and tapered dedicated plastic stent. The outcomes of this study included the technical success, clinical success, AE incidence, and recurrent biliary obstruction (RBO) associated with the procedure. During the study period, EUS-HGAS without dilation device usage was attempted for 57 patients with MDBO due to pancreatic cancer. The technical and clinical success rates were 91.2% (52/57) each. The median procedural time was 25min. The rates of early and late AE besides RBO were 3.5% (2/57) and 1.9% (1/52), respectively. The incidence rate of RBO was 30.8% (16/52), and the median time to RBO was 245days. The rate of successful endoscopic reintervention for RBO via the fistula was 100% (16/16). EUS-HGAS without the use of dilation devices showed good technical feasibility with a low AE rate. It may be a useful option for MDBO associated with pancreatic cancer when the transpapillary approach is difficult.

Effect of ursodeoxycholic acid after self-expandable metal stent placement in malignant distal biliary obstruction: a propensity score–matched cohort analysis

Sludge occlusion is a primary reason for recurrent biliary obstruction (RBO) after self-expandable metallic stent (SEMS) placement. However, the efficacy of ursodeoxycholic acid (UDCA) for SEMS occlusion remains unexplored to date. This study aimed to evaluate the efficacy of UDCA after SEMS placement for malignant distal biliary obstruction (MDBO). Three hundred fifty-four patients were included, of which 60 received UDCA. Additionally, we conducted a propensity score-matched cohort analysis on 110 patients with SEMS placement for MDBO to reduce selection bias. Patients were categorized into 2 groups of 55 each, based on whether they received UDCA. In the UDCA group, the treatment was administered for more than a month. The primary endpoint was the time to RBO (TRBO) after SEMS placement. The secondary endpoint was to evaluate SEMS occlusion rate and early adverse events (AEs). The cumulative SEMS occlusion rate was 41.8% and 18.2% in the groups with and without UDCA, respectively (P= .0119). Median TRBO was significantly longer in the control group than in the UDCA group (528 vs 154 days, P= .0381). In the multivariate analysis, UDCA administration was identified as the independent risk factor for reducing TRBO (hazard ratio, 2.28; 95% confidence interval, 1.06-4.88; P= .0348). The overall early AE rate showed insignificant differences between groups. Administering UDCA after SEMS placement was not efficacious for prolonging the TRBO in MDBO. Moreover, administering UDCA beyond a month might increase the risk of stent sludge occlusion. (Clinical trial registration number: UMIN000046862.).

Re-intervention with 10-mm vs 12-mm covered self-expandable metallic stent for recurrent unresectable distal biliary obstruction in patients with previous stent implantation.

Treatment for unresectable distal malignant biliary obstruction (DMBO) involves placing a 10-mm covered self-expandable metallic stent (CSEMS). In recurrent biliary obstruction (RBO), replacement of the CSEMS is recommended; however, the appropriate stent type remains unknown. We speculated that large-bore CSEMSs would provide longer patency. We compared the efficacy of 10-mm and 12-mm CSEMS in patients with RBO. We retrospectively retrieved data on patients who underwent CSEMS replacement from the endoscopic database. We investigated the time to RBO (TRBO) after CSEMS replacement. The hazard ratio (HR) for the the second TRBO was estimated using the Cox proportional hazard model. The estimated median second TRBO was determined using the Kaplan-Meier method. Among the 493 patients with DMBOs treated with 10-mm CSEMS, 48 and 29 patients underwent re-intervention with 10-mm and 12-mm CSEMS, respectively. The use of 12-mm CSEMS was inversely associated with second TRBO (multivariable-adjusted HR, 0.62; 95% CI, 0.39-0.98; P=.042). The estimated median second TRBO was greater with the 12 mm CSEMS than with the 10 mm variety (562 days vs 207 days; P=.019). The second intervention with 12-mm CSEMS was associated with a longer TRBO.

The Feasibility of Whole-Liver Drainage with a Novel 8 mm Fully Covered Self-Expandable Metal Stent Possessing an Ultra-Slim Introducer for Malignant Hilar Biliary Obstructions.

Background: In the case of an unresectable malignant hilar biliary obstruction (MHBO), the optimal drainage method has not yet been established. Recently, an 8 mm, fully covered, self-expandable metal stent (FCSEMS) with an ultra-slim introducer has become available. In this article, the results of whole-liver drainage tests using this novel FCSEMS for MHBO are reported. Methods: Unresectable MHBOs up to Bismuth IIIa with strictures limited to the secondary branches were eligible. The proximal end of the stent was placed in such a way as to avoid blocking the side branches, and the distal end was placed above the papilla when possible. Consecutive patients treated between April 2017 and January 2021 were retrospectively analyzed. The technical and functional success rates, rates and causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), revision for RBO, and adverse events (AEs) were evaluated. Results: Eleven patients (Bismuth I/II/IIIa: 1/7/3) were enrolled. Two stents were placed in nine patients and three were placed in two patients. Both the technical and functional success rates were 100%. RBO occurred in four (36%) patients due to sludge formation. Revision was performed for three patients, with the successful removal of all stents. The median TRBO was 187 days, and no late AEs other than the RBO occurred. Regarding the distal position of the stent, the RBO rate was significantly lower (14.3% vs. 75%, p = 0.041) and the cumulative TRBO was significantly longer (median TRBO: not reached vs. 80 days, p = 0.031) in the case of the placement above the papilla than the placement across the papilla. Conclusion: For unresectable MHBOs of Bismuth I, II, and IIIa, whole-liver drainage with a novel 8 mm FCSEMS possessing an ultra-slim introducer was feasible and potentially safe, with favorable stent patency. Placement above the papilla might be preferrable to placement across the papilla.

Endoscopic radiofrequency ablation for ingrowth occlusion after bilateral metal stent placement for malignant hilar biliary obstruction: a prospective pilot study

Endoscopic biliary radiofrequency ablation (RFA) may be an option for the treatment of ingrowth occlusion after self-expandable metal stent (SEMS) deployment; however, its utility remains uncertain. This study aimed to examine the feasibility of RFA for the palliation of ingrowth after bilateral SEMS placement in patients with malignant hilar biliary obstruction. This prospective, single-center, pilot study enrolled 30 patients who met the eligibility criteria between April 2020 and March 2022. Study outcomes were technical success, clinical success, recurrent biliary obstruction (RBO), and adverse events (AEs) besides RBO associated with RFA for ingrowth occlusion. Furthermore, factors predictive of clinical success were evaluated. Technical and clinical success rates were 93.3% (28/30) and 71.4% (20/28), respectively. The rates of early and late AEs were 6.7% (2/30) and 10.0% (2/20), respectively. The incidence rate of RBO after RFA was 45.0% (9/20), and the median time to RBO was 163 days. Multivariate analysis of the factors affecting clinical success revealed a positive association between the recanalization diameter on the ingrown part within the SEMS (odds ratio, 1.13; 95% confidence interval, 1.01-1.26; P= .038). The calculated optimal cutoff for the ratio of the recanalization diameter to the SEMS diameter for predicting clinical success was 51.1%. Endoscopic biliary RFA elicited promising results, with good long-term stent patency and without the requirement of any additional stent placement, for the palliation of ingrowth occlusion after bilateral SEMS placement. However, the clinical success rate was insufficient, necessitating improvements in the future. (Clinical trial registration number: UMIN000040154.).

Outcome of metal vs plastic stents for biliary obstruction in patients with pancreatic carcinoma undergoing neoadjuvant chemoradiotherapy: A systematic review and meta-analysis.

Preoperative biliary drainage (PBT) may be warranted in patients with borderline resectable or locally advanced pancreatic carcinoma before neoadjuvant therapy (NAT) to relieve obstructive jaundice. However, it is unclear if the use of self-expanding metal stents (SEMS) has any benefit over plastic stents in this setting. We searched electronic databases from inception to February 11, 2022 to identify studies comparing SEMS and plastic stents for PBT in patients with pancreatic carcinoma undergoing NAT. Random effect models were used to determine pooled rates of recurrent biliary obstruction (RBO) and/or need for reintervention, stent-related complications and surgical outcome. A total of 10 studies (474 patients; metal group-37.1%) were included. Pooled risk ratio of RBO and/or need for reintervention was lower in the metal group (RR, 0.23 [95% CI: 0.11-0.45, I2 = 60%]). Pooled risks of stent occlusion (RR, 0.43 [95% CI: 0.24-0.80, I2 = 45%]) and stent-related cholangitis (RR, 0.37 [95% CI: 0.17-0.78, I2 = 1%]) were lower in the metal group. However, risks of stent-related cholecystitis (RR, 1.51 [95% CI: 0.36-6.41, I2 = 0%]) and pancreatitis (RR, 1.52 [95% CI: 0.07-31.84, I2 = 66%]) were higher in the metal group. The metal group was also associated with a reduced risk of delay in NAT (RR, 0.38 [95% CI: 0.18-0.80, I2 = 14%]). Pooled risk ratio of R0 resection and postoperative complications was equal amongst both groups. Metal stents are associated with reduced risk of RBO and/or need for reintervention, reduced risk of stent occlusion and cholangitis as compared to plastic stents in patients with pancreatic carcinoma undergoing NAT.

Bilateral verses bilateral with tri-segmental endoscopic drainage using metal stents for high-grade malignant hilar biliary obstructions: A multicenter, randomized controlled trial: BRAVE study (BRAVE study).

Introduction:Bilateral endoscopic drainage with self-expanding metallic stent (SEMS) can be used to manage hilar malignant biliary obstruction (HMBO) more effectively in comparison to unilateral drainage. An increased drainage area is predicted to prolong stent patency and patient survival. However, few reports have described the utility of trisegmental drainage and the benefits of using trisegmental drainage remain unknown. Thus, we launched a randomized clinical trial (RCT) to compare the clinical outcomes between bilateral and trisegmental drainage using SEMSs in patients with high-grade HMBO.Methods and analysis:This study was conducted as a multicenter randomized control trial (RCT) in 8 high-volume medical centers in Japan, and will prove the non-inferiority of bilateral drainage to trisegmental drainage. Patients with unresectable HMBO with Bismuth type IIIa or IV who pass the inclusion and exclusion criteria will be randomized to receive bilateral or trisegmental drainage at a 1:1 ratio. At each center, the on-site study investigators will obtain informed consent from the candidates, and will use an electronic data capture system (REDCap) to input necessary information, and register candidates with the registration secretariat. The primary endpoint is the rate of non-recurrent biliary obstruction (RBO) at 180 days after SEMSs placement. A −10% non-inferiority margin is assumed in the statistical analysis of the primary endpoint. Secondary endpoints include the rate of technical and clinical success, time to recurrent biliary obstruction (TRBO), causes of RBO, procedure-related adverse events (AEs), procedure time, TRBO with or without endoscopic sphincterotomy, overall survival, and the technical and clinical success rates at reintervention.Discussion:If the non-inferiority of bilateral drainage is demonstrated, it is predicted that the procedure time will be shortened and the medical cost will be reduced, which will be beneficial to the patient and the medical economy.Trial registration:Registered in Japan Registry of Clinical Trial-Registration (trial number. jRCTs062220038). This version number 1. Protocol dated Jun 23, 2022.

Potential significance of uncovered self-expandable metal stents for distal malignant biliary obstruction: A propensity score-adjusted competing risk regression analysis.

ObjectivesSelection criteria for self‐expandable metal stents (SEMSs) with or without cover during palliative treatment of distal malignant biliary obstruction (DMBO) remain unclear. We evaluated factors associated with time to recurrent biliary obstruction (TRBO) in fully covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs).MethodsWe retrospectively analyzed consecutive patients with DMBO who received a SEMS. TRBO was determined using the Kaplan–Meier analysis, and complications were compared between the FCSEMS and UCSEMS groups. After TRBO‐associated factors were extracted using multivariate competing‐risks regression (CRR), propensity score‐adjusted CRRs were performed to verify their robustness.ResultsThere were 180 patients (66 FCSEMSs and 114 UCSEMSs) enrolled in this study. There was no significant difference between median TRBO in the FCSEMS and UCSEMS groups (275 vs. 255 days, p = 0.67). Complications were more frequent in the FCSEMS than UCSEMS group (21.2% vs. 8.8%; p = 0.023). Multivariate CRR for TRBO‐associated factors revealed that “pancreatic ductal carcinoma (PDAC) treated with UCSEMS” was the only independent predictor of TRBO (p = 0.03). Similarly, the propensity score‐adjusted CRRs showed no significant difference in TRBO in “FCSEMS” vs “UCSEMS” (p = 0.96); however, there was a significant difference in “PDAC using UCSEMS” vs “other” (p = 0.043). In the palliative care group including any DMBO without chemotherapy, the first quartile of the TRBO of UCSEMS was 100 days.ConclusionsUCSEMSs are a possible option for both patients with DMBO arising from PDAC and for patients with any DMBO receiving palliative care who should avoid SEMS‐related complications.

Efficacy of a dedicated plastic stent in endoscopic ultrasound-guided hepaticogastrostomy during the learning curve: cumulative multi-center experience

Background and objectives Currently, there are no reports on the learning curve of endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) using dedicated plastic stents. Therefore, we evaluated the outcomes of EUS-HGS using dedicated plastic stents at tertiary referral centers during the initial development phase of EUS-HGS. Materials and methods Endoscopic retrograde cholangiopancreatography (ERCP) was strictly prioritized over EUS-HGS. Twenty-three consecutive patients treated using EUS-HGS with a 7-Fr dedicated plastic stent over 4 years beginning in 2018 were analyzed retrospectively. Results The most common primary disease was pancreatic cancer, and the most common reason for difficulty in ERCP was duodenal obstruction, followed by surgically altered anatomy. The overall technical success rate of EUS-HGS was 95.7% (22/23). One failed case was converted to EUS-guided choledochoduodenostomy. The clinical success rate was 90.9% (20/22). Adverse events (AEs) related to the procedure were observed in four (17.4%) patients, including mild biliary peritonitis in three (13.0%) and mild cholangitis in one (4.3%) patient; all patients received conservative therapy. No serious AEs, such as stent migration, bleeding, or gastrointestinal perforation, were observed. Recurrent biliary obstruction (RBO) was observed in eight (34.8%) patients. Of these, HGS stent replacement was performed in four patients, and other treatments were performed in the remaining four patients. Another four (17.4%) patients did not develop RBO but underwent periodic HGS stent replacement. Conclusions EUS-HGS using a dedicated plastic stent was performed safely even in its initial phase of introduction. The approach using this stent can be useful in case of ERCP failure for biliary decompression because of the high feasibility and low risk of serious adverse events.

Retrospective evaluation of slim fully covered self-expandable metallic stent for unresectable malignant hilar biliary obstruction.

There have been few reports of covered self-expandable metallic stent (SEMS) placement for malignant hilar-biliary obstruction (MHBO) because of risk of biliary branch obstruction. We studied feasibility and efficacy of 6-mm-diameter, slim, fully covered SEMS (SFCSEMS) in a relatively large cohort. We retrospectively evaluated SFCSEMS in unresectable MHBO from December 2016 to September 2021 in Juntendo University Hospital. We enrolled consecutive 54 unresectable MHBO (18 bile duct, 11 gallbladder, eight pancreatic, two hepatocellular, and 15 metastatic cancer cases) including Bismuth-type II (n=11), III (n=17), and IV (n=26), and placed two (n=35) or three (n=19) SFCSEMS. The technical and clinical success rate was 100% and 92.5%, respectively, with 76.3min of mean procedure time. Recurrent biliary obstruction (RBO) was observed in 35.2% and the median cumulative time to RBO (TRBO) was 181 days. Other adverse events were 11.1% (four mild-pancreatitis, one segmental-cholangitis, and one cholecystitis). There were no failed cases of stent exchange and second SFCSEMS (n=6) showed significantly lower RBO (16.7% vs. 81.8%, P=.0364) and longer TRBO (undefined vs 86 days; P=.0617) than plastic stent (n=11). Endoscopic placement of SFCSEMS for unresectable MHBO was effective and feasible with low incidence of segmental cholangitis, and exchange strategy of SFCSEMS was promising.

Comparison of an Inside Stent and a Fully Covered Self-Expandable Metallic Stent as Preoperative Biliary Drainage for Patients with Resectable Perihilar Cholangiocarcinoma.

Background There is a need for a more tolerable preoperative biliary drainage (PBD) method for perihilar cholangiocarcinoma (PHCC). In recent years, inside stents (ISs) have attracted attention as a less suffering PBD method. Few studies have compared IS with a fully covered self-expandable metallic stent (FCSEMS) as PBD for resectable PHCC. The aim of this study is to compare them. Methods This study involved 86 consecutive patients (IS: 51; FCSEMS: 35). The recurrent biliary obstruction (RBO) rate until undergoing surgery or being diagnosed as unresectable, time to RBO, factors related to RBO, incidence of adverse events related to endoscopic retrograde cholangiography, and postoperative complications associated with each stent were evaluated retrospectively. Results There was no significant difference between the two groups in the incidence of adverse events after stent insertion. After propensity score matching, the mean (SD) time to RBO was 37.9 (30.2) days in the IS group and 45.1 (35.1) days in the FCSEMS group, with no significant difference (P=0.912, log-rank test). A total of 7/51 patients in the IS group and 3/35 patients in the FCSEMS group developed RBO. The only risk factor for RBO was bile duct obstruction of the future excisional liver lobe(s) due to stenting (HR 29.8, P=0.008) in the FCSEMS group, but risk factors could not be indicated in the IS group. There was no significant difference in the incidence of bile leakage or liver failure. In contrast, pancreatic fistula was significantly more common in the FCSEMS group (13/23 patients) than in the IS group (3/28 patients) (P < 0.001), especially in patients who did not undergo pancreatectomy (P=0.001). Conclusions As PBD, both IS and FCSEMS achieved low RBO rates. Compared with FCSEMS, IS shows no difference in RBO rate, is associated with fewer postoperative complications, and is considered an appropriate means of PBD for resectable PHCC. This trail is registered with UMIN000025631.

Safety and Efficacy of a Large-Bore Biliary Metallic Stent for Malignant Biliary Obstruction.

Self-expandable metallic stents (SEMSs) are typically inserted in patients with unresectable malignant biliary obstruction. However, SEMSs are susceptible to occlusion. To overcome this issue, we developed a large-bore, dumbbell-shaped, fully covered SEMS (FCSEMS-L) and compared its efficacy and safety with those of a conventional FCSEMS (FCSEMS-C) in patients with malignant biliary obstruction. Methods: Patients with unresectable distal malignant biliary obstruction were retrospectively enrolled between January 2011 and February 2021. All patients underwent endoscopic insertion of FCSEMSs. Recurrent biliary obstruction (RBO), patient survival time, complications, and prognosis were analyzed. Results: RBO occurred in 31 patients (35.6%) who received an FCSEMS-L, and in 34 (45.9%) who received an FCSEMS-C. Stent occlusion occurred in 19 patients (21.8%) who received an FCSEMS-L, and in 22 (29.7%) who received an FCSEMS-C. Stent migration occurred in 12 patients (13.8%) with an FCSEMS-L and 12 (16.2%) with an FCSEMS-C. The median time to RBO (TRBO) was 301 days with an FCSEMS-L and 203 days with an FCSEMS-C. The median survival time was 479 days with an FCSEMS-L and 523 days with an FCSEMS-C. The TRBO and patient survival time did not significantly differ between the two groups. Conclusions: There were no significant differences in efficacy and complication rates between the fully covered large bore SEMSs and conventional fully covered SEMSs.

Long-term outcomes of endoscopic double stenting using an anti-reflux metal stent for combined malignant biliary and duodenal obstruction.

To evaluate long-term outcomes of endoscopic double stenting using anti-reflux metal stents (ARMS) for combined malignant biliary and duodenal obstruction. Consecutive patients with advanced pancreatic cancer who received endoscopic double stenting with self-expandable metal stents (SEMS) for combined malignant biliary and duodenal obstruction at our institution between July 2014 and March 2021 were evaluated. Patients were divided into the ARMS group, endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) group, and covered metal stent-transpapillary (CMS-transpapillary) group. A Duckbill-type metal stent was used in all ARMS cases. Thirty-eight patients were enrolled: ARMS group (n=16), EUS-HGS group (n=13), and CMS-transpapillary group (n=9). Overall survival among three groups were not significantly different. Recurrent biliary obstruction(RBO) rates of the ARMS, EUS-HGS, and CMS-transpapillary groups were 12.5%, 61.5%, and 88.9% (P < .01) and median time to recurrent biliary obstructions (TRBOs) were not reached, 125 days, and 7 days (P < .01). Median TRBOs of ARMS-choledochoduodenostomy and ARMS-transpapillary were not statistically different. Major causes of RBO were stent occlusion and symptomatic stent migration in the ARMS group, hyperplasia in the EUS-HGS group, and non-occlusion cholangitis in the CMS-transpapillary group. Endoscopic double stenting with ARMS might be an option for combined malignant biliary and duodenal obstruction.

Angle of covered self-expandable metallic stents after placement is a risk factor for recurrent biliary obstruction.

BACKGROUNDStudies have shown that covered self-expandable metallic stents (CSEMS) with a low axial forces after placement can cause early recurrent biliary obstruction (RBO) due to precipitating sludge formation. AIMTo ascertain whether the angle of CSEMS after placement is a risk factor for RBO in unresectable distal malignant biliary obstruction (MBO).METHODSBetween January 2010 and March 2019, 261 consecutive patients underwent self-expandable metallic stent insertion by endoscopic retrograde cholangiopancreatography at our facility, and 87 patients were included in this study. We evaluated the risk factors for RBO, including the angle of CSEMS after placement as the primary outcome. We measured the obtuse angle of CSEMS after placement on an abdominal radiograph using the SYNAPSE PACS system. We also evaluated technical and functional success, adverse events, time to RBO (TRBO), non-RBO rate, survival time, cause of RBO, and reintervention procedure as secondary outcomes.RESULTSWe divided the patients into two cohorts based on the presence or absence of RBO. The angle of CSEMS after placement (per 1° and per 10°) was evaluated using the multivariate Cox proportional hazard analysis, which was an independent risk factor for RBO in unresectable distal MBO [hazard ratio, 0.97 and 0.71; 95% confidence interval (CI): 0.94-0.99 and 0.54-0.92; P = 0.01 and 0.01, respectively]. For early diagnosis of RBO, the cut-off value of the angle of CSEMS after placement using the receiver operating characteristic curve was 130° [sensitivity, 50.0%; specificity 85.5%; area under the curve 0.70 (95%CI: 0.57-0.84)]. TRBO in the < 130° angle group was significantly shorter than that in the ≥ 130° angle group (P < 0.01).CONCLUSIONThis study suggests that the angle of the CSEMS after placement for unresectable distal MBO is a risk factor for RBO. These novel results provide pertinent information for future stent management.