Malignant Hilar Biliary Obstruction Research Articles

Evaluating optimal bilateral biliary stenting in endoscopic reintervention after initial plastic stent dysfunction for unresectable malignant hilar biliary obstruction: Retrospective cross-sectional study.

The placement of plastic stents (PS), including intraductal PS (IS), is useful in patients with unresectable malignant hilar biliary obstruction (UMHBO) because of patency and ease of endoscopic reintervention (ERI). However, the optimal stent replacement method for PS remains unclear. This retrospective study included 322 patients with UMHBO. Among them, 146 received PS placement as initial drainage (across-the-papilla PS [aPS], 54; IS, 92), whereas 75 required ERI. Eight bilateral aPS, 21 bilateral IS, and 17 bilateral self-expandable metallic stent (SEMS) placements met the inclusion criteria. Rates of technical and clinical success, adverse events, recurrent biliary obstruction (RBO), time to RBO (TRBO), overall survival, and secondary ERI were compared. There were no significant intergroup differences in rates of technical or clinical success, adverse events, RBO occurrence, oroverall survival. The median TRBO was significantly shorter in theaPS group (47 days) than IS (91 days; P = 0.0196) and SEMS (143 days; P < 0.01) groups. Median TRBO did not differ significantly between the IS and SEMS groups (P = 0.44). On Cox multivariate analysis, the aPS group had the shortest stent patency (hazard ratio 2.67 [95% confidence interval 1.05-6.76], P = 0.038). For secondary ERI, the median endoscopic procedure time was significantly shorter in the IS (22 min) vs. SEMS (40 min) group (P = 0.034). Bilateral IS and SEMS placement featured prolonged patency after first ERI. Because bilateral IS placement is faster than SEMS placement and IS can be removed during secondary ERI, it may be a good option for first ERI.

Trends of Endoscopic Palliation for Advanced Malignant Hilar Biliary Obstruction

Malignant hilar biliary obstruction (MHO), an aggressive type of perihilar biliary obstruction caused by cholangiocarcinoma, gallbladder cancer, or other metastatic malignancies, has a poor prognosis. Surgical resection is the only curative treatment for biliary malignancies. However, most patients with MHO cannot undergo surgery upon presentation because of their advanced inoperable state or poor performance resulting from old age or comorbid diseases. Therefore, palliative biliary drainage is required to improve symptomatic jaundice and quality of life. Preoperative biliary drainage is controversial in resectable cases of MHO. Preoperative biliary drainage should be considered according to specific selection criteria. Palliative drainage is currently the mainstay of symptomatic treatment. Compared with percutaneous access, primary endoscopic palliation using plastic or metal stents has recently shown higher technical feasibility and clinical success without increasing the frequency of adverse events, even in high-degree MHO. However, the use of stents still has numerous limitations, including challenges in determining the optimal type of stent, number of stents, deployment method, and additional local therapies. Therefore, this report presents the current optimal endoscopic drainage status for MHO based on recent guidelines and published literature.

A Novel Method of Calculating the Drained Liver Volume Using a 3D Volume Analyzer for Biliary Drainage of Unresectable Malignant Hilar Biliary Obstruction

ObjectivesIn patients with unresectable malignant hilar biliary obstruction (UMHBO), drainage of ≥ 50% liver volume correlates with better clinical outcomes. Accurately measuring the liver volume to be drained by biliary stents is required. We aimed to develop a novel method for calculating the drained liver volume (DLV) using a 3D volume analyzer (3D volumetry), and assess the usefulness for drainage in patients with UMHBO.MethodsThree-dimensional volumetry comprises the following steps: (1) manual tracing of bile duct using 3D imaging system; (2) 3D reconstruction of bile duct and liver parenchyma; and (3) calculating DLV according to the 3D distribution of bile ducts. Using 3D volumetry, we reviewed data of patients who underwent biliary drainage for UMHBO, calculated the DLV, and determined the association between DLV and biliary drainage outcome.ResultsThere were 104 eligible cases. The mean DLV was 708 ± 393 ml (53% ± 21%). and 65 patients (63%) underwent drainage of ≥50% liver volume. The clinical success rate was significantly higher in patients with DLV ≥ 50% than in patients with DLV < 50% (89% vs. 28%, P < 0.001). The median time to recurrence of biliary obstruction (TRBO) and survival time were significantly longer in patients with DLV ≥ 50% than in patients with DLV < 50% (TRBO, 292 vs. 119 days, P = 0.03; survival, 285 vs. 65days, P = 0.004, log-rank test, respectively).ConclusionsThree-dimensional volumetry, a novel method to calculate DLV accurately according to bile duct distribution was useful for drainage in UMHBO patients.

Malignant hilar biliary obstruction: palliative-stenting during end-of-life care

Malignant hilar biliary obstruction: palliative-stenting during end-of-life care

Primary percutaneous stenting above the ampulla for unresectable malignant hilar biliary obstruction: a single-center phase II trial

Primary percutaneous stenting above the ampulla for unresectable malignant hilar biliary obstruction: a single-center phase II trial

Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): a multicenter randomized controlled trial - clinical trials in progress

Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): a multicenter randomized controlled trial - clinical trials in progress

Endoscopic Treatment of Malignant Hilar Biliary Obstruction.

Stent implantation is an effective approach for palliative treatment of Bismuth-Corlette type III-IV malignant hilar biliary obstructions (MHBOs). In this article, we reviewed the currently used access methods for biliary stent placement (percutaneous transhepatic biliary drainage, endoscopic biliary drainage, endosonography guided biliary drainage), the available stent types (plastic stent, self-expanding metallic stent, full cover self-expanding metallic stent, radioactive self-expanding metallic stent), major approaches (unilateral, bilateral) and deployment methods (stent-in-stent, stent-by-stent). Finally, this review gives an outlook on perspectives of development in stenting and other palliative methods in MHBO.

Comparison of unilateral and bilateral intraductal plastic stent placement for unresectable malignant hilar biliary obstruction: A propensity score-matched cohort analysis.

Although intraductal plastic stent (IS) placement is an effective treatment for unresectable malignant hilar biliary obstruction (UMHBO), the effectiveness of unilateral and bilateral IS drainage remains controversial. This retrospective study investigated the effectiveness of bilateral IS placement for UMHBO using the propensity score matching method. Patients who underwent transpapillary endoscopic stenting for UMHBO were analyzed for technical and clinical success, adverse events, and time to recurrent biliary obstruction (TRBO). A total of 321 patients were enrolled in the study with 27 patients in each unilateral and bilateral IS group in the propensity score-based cohort. Technical success was 100%, while clinical success was 93% and 96% in the unilateral and bilateral IS groups, respectively (p = 1.0). Cholecystitis occurred in 4% and 7%, respectively (p = 1.0). The median TRBO was shorter in the unilateral group (129 [5-383] days) than that in the bilateral group (226 [16-563] days) (p = .0281). Bilateral IS placement was an independent long TRBO factor (hazard ratio [HR] 0.46; 95% confidence interval [CI]: 0.21-0.97; p = .041). Unilateral and bilateral IS placement had high technical and clinical success rates in primary stent placement. However, bilateral IS placement showed a longer TRBO. Bilateral IS placement may be a good option for initial UMHBO drainage.

Endoscopic ultrasound-guided hepaticogastrostomy with bridging as reintervention for stent occlusion in malignant hilar biliary obstruction.

Endoscopic ultrasound-guided hepaticogastrostomy with bridging as reintervention for stent occlusion in malignant hilar biliary obstruction.

Endoscopic nasobiliary drainage versus endoscopic biliary stenting for preoperative biliary drainage in patients with malignant hilar biliary obstruction: A propensity score matched multicenter comparative study.

For preoperative biliary drainage (PBD) of malignant hilar biliary obstruction (MHBO), current guidelines recommend endoscopic nasobiliary drainage (ENBD) due to the higher risk of cholangitis after endoscopic biliary stenting (EBS) during the waiting period before surgery. However, few studies have supported this finding. Therefore, we aimed to compare the outcomes of preoperative ENBD and EBS in patients with MHBO. Patients with MHBO who underwent laparotomy for radical surgery after ENBD or EBS were included from retrospectively collected data from 13 centers (January 2014 to December 2018). We performed a 1:1 propensity score matching between the ENBD and EBS groups. These patients were compared for the following: cholangitis and all adverse events (AEs) after endoscopic biliary drainage (EBD) until surgery, time to cholangitis development after EBD, post-surgical AEs, and in-hospital death after surgery. Of the 414 patients identified, 355 were analyzed in this study (226 for ENBD and 129 for EBS). The matched cohort included 63 patients from each group. The proportion of cholangitis after EBD was similar between the two groups (20.6% vs. 25.4%, p = 0.67), and no significant difference was observed in the time to cholangitis development. The proportions of surgical site infections, bile leaks, and in-hospital mortality rates were similar between the groups. For PBD of MHBO, the proportion of AEs, including cholangitis, after EBD until surgery was similar when either ENBD or EBS was used.

The evaluation of bilateral stenting using braided or laser-cut self-expandable metallic stent for malignant hilar biliary obstruction.

Bilateral self-expandable metallic stent (SEMS) placement for unresectable malignant hilar biliary obstruction (UMHBO) is an effective option for biliary drainage with long-term stent patency. Laser-cut and braided SEMS can be used for bilateral SEMS placement. This study aimed to clarify any differences in the clinical features and proper use of the laser-cut and braided SEMS placement using the stent-in-stent method for UMHBO. In this study, 78 patients who underwent bilateral stent-in-stent SEMS placement for UMHBO were included. The patients were divided into the laser-cut (n = 33) and braided groups (n = 45). Both groups were compared for technical and clinical success, adverse events (AEs), time to recurrent biliary obstruction (TRBO), overall survival, and endoscopic reintervention (ERI). There were no significant differences in technical and clinical success rates (laser-cut vs. braided group, 97% vs. 95.6%, P = 1.0), AEs (21.2% vs. 15.6%. P = 0.56), median TRBO (242days vs. 140days, P = 0.36), and median overall survival (654days vs. 675days, P = 0.58). ERI was required in 15 patients in the laser-cut group and in 20 patients in the braided group. The technical and clinical success rates of ERI (60% vs. 85%) were not significantly different (P = 0.13); however, the median ERI procedure time was significantly longer in the laser-cut group (38min) than in the braided group (22min; P = 0.02). No significant difference in initial SEMS placement was noted between the laser-cut and braided groups; however, the laser-cut group required a longer ERI procedure time than that required by the braided group. The use of braided SEMS may be a convenient option for ERI.

Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: a multicenter, randomized trial.

The efficacy of the suprapapillary placement of inside plastic stents (iPSs) for unresectable malignant hilar biliary obstructions (MHOs) is unknown compared with that of uncovered inside metal stents (iMSs). This randomized controlled trial was designed to evaluate the outcomes of endoscopic placement of these stents for unresectable MHOs. This open-label, randomized study was conducted at 12 Japanese institutions. The enrolled patients with unresectable MHOs were allocated to iPS and iMS groups. The primary outcome was defined as the time to recurrent biliary obstruction in patients for whom the intervention was both technically and clinically successful. Among 87 enrollments, 38 patients in the iPS group and 46 patients in the iMS group were analyzed. Technical success rates were 100% (38 of 38) and 96.6% (44 of 46), respectively (P= 1.00). After transferring 1 unsuccessful iMS-group patient to the iPS group (since iPSs were deployed), the clinical success rates were 90.0% (35 of 39) for the iPS group and 88.9% (40 of 45) for the iMS group from a per-protocol analysis (P= 1.00). Among the patients with clinical success, the median times to recurrent biliary obstruction were 250 (95% confidence interval, 85-415) and 361 (95% confidence interval, 107-615) days (log-rank test, P= .34). No differences were detected in rates of adverse events. This Phase II randomized trial did not show any statistically significant difference in stent patency between suprapapillary plastic versus metal stents. Considering the potential advantages of plastic stents for malignant hilar obstruction, these findings suggest that suprapapillary plastic stents could be a viable alternative to metal stents for this condition.

Endoscopic reintervention after unilateral metal stent deployment for MHBO using SIS method.

Endoscopic biliary drainage is the main treatment for unresectable malignant hilar biliary obstruction (MHBO). Recurrent biliary obstruction (RBO) often occurs after unilateral metal stent deployment. Endoscopic reintervention can be complex for this problem, especially for drainage of the contralateral bile duct. The stent-in-stent (SIS) method is a possible solution to this problem. Our objective was to evaluate the safety and feasibility of the SIS method for endoscopic reintervention in patients with RBO due to MHBO after unilateral metal stent deployment. Eleven patients with MHBO received endoscopic reintervention using the SIS method to manage RBO after unilateral metal stent deployment. Clinical data, including technical and clinical success, procedure time, adverse events and complications, stent patency, RBO of the revisionary stent, and survival time were recorded. Nine patients (82%) achieved technical success, and all 9 of them also achieved clinical success. The 2 unsuccessful cases received percutaneous transhepatic cholangial drainage. The median procedure time was 73 minutes. The 3 adverse events were post-endoscopic retrograde cholangiopancreatography pancreatitis, cholangitis, and liver abscess. 6 patients (67%) experienced RBO of the revisionary stent, the median time to RBO of the revisionary stent was 95.5 days, the median survival time after reintervention was 111 days, and the median overall survival time was 305.5 days. Endoscopic reintervention after previous unilateral metal stent deployment using the SIS method appears to be safe and technically feasible for MHBO patients who experience RBO.

Utility of bilateral intraductal plastic stent for malignant hilar biliary obstruction compared with bilateral self-expandable metal stent: a propensity score–matched cohort analysis

Intraductal plastic stent (IS) placement for unresectable malignant hilar biliary obstruction (UMHBO) is an effective option for biliary drainage. However, the effectiveness of bilateral IS placement compared with bilateral self-expandable metal stent (SEMS) placement remains unclear. Overall, 301 patients with UMHBO were enrolled; 38 patients underwent bilateral IS placement (IS group) and 38 patients underwent SEMS placement (SEMS group) in the propensity score-based cohort. Both groups were compared for technical and clinical success, adverse events (AEs), recurrent biliary obstruction (RBO), time to RBO (TRBO), overall survival (OS), and endoscopic reintervention (ERI). No significant differences were observed between the groups regarding technical and clinical success, AEs and RBO occurrence rates, TRBO, or OS. The median initial endoscopic procedure time was significantly shorter in the IS group (23 vs 49 minutes, P< .01). ERI was performed on 20 and 19 patients in the IS and SEMS groups, respectively. The median ERI procedure time was significantly shorter in the IS group (22 vs 35 minutes, P= .04). Median TRBO after ERI with plastic stent placement tended to be longer in the IS group (306 vs 56 days, P= .068). A Cox multivariate analysis showed that the IS group was the significant related factor for TRBO after ERI (hazard ratio, .31; 95% confidence interval, .25-.82; P= .035). Bilateral IS placement can reduce the duration of the endoscopic procedure and provide sufficient stent patency both initially and after ERI stent placement, and the stents are removable. Bilateral IS placement is considered a good option for initial UMHBO drainage. (Clinical trial registration number: UMIN000050546.).

Risk Factors for Early- and Late-Onset Cholecystitis after Y-Configured Metal Stent Placement in Patients with Malignant Hilar Biliary Obstruction: A Single-Center Study.

This study evaluated the prevalence and risk factors of early- (within 7 days of placement) and late-onset (after 7 days of placement) cholecystitis after Y-configured metal stent placement. Between June 2005 and August 2020, 109 patients who had been treated with Y-configured metal stents for malignant hilar obstruction were enrolled in the study. We retrospectively analyzed the potential risk factors for post-stent cholecystitis. The presence of diabetes (p = 0.042), the length of the common part of the Y-stent (p = 0.017), filling of the gallbladder with contrast medium during the procedure (p = 0.040), and tumor invasion of the cystic duct accompanied by filling the gallbladder with contrast medium during metal stent placement (p = 0.001) were identified as important risk factors. In cases of late-onset cholecystitis, stent obstruction (p = 0.004) and repeated endoscopic procedures due to stent malfunction (p = 0.024) were significant risk factors. In the multivariate logistic regression analysis, significant risk factors were the length of the common part of the Y-stent (p = 0.032) in early-onset cholecystitis and stent obstruction (p = 0.007) in late-onset cholecystitis. This study demonstrated that early-onset cholecystitis may occur in patients according to the length of the common portion of the Y-stent. In contrast, late-onset cholecystitis may occur in patients with stent obstruction.

Biliary intervention combined with lenvatinib+ PD-1 inhibitor of Klatskin tumor complicated with malignant obstructive jaundice.

e14620 Background: Hilar Cholangiocarcinoma (Klatskin tumor) is a rare and highly aggressive cancer that occurs at or near the junction of the right and left hepatic ducts. Gemcitabine + cisplatin has been established as an effective first-line treatment. However, this malignancy is commonly complicated by malignant biliary obstruction which may gradually damage patients’ liver function and may limit the chemotherapy. In addition, Cumulative clinical evidence showed that tyrosine kinase inhibitor (TKI) combined with immunotherapy is represented as a promising alternative. This study aimed to evaluate the clinical value of biliary intervention combined with the Lenvatinib+PD-1 inhibitor (Tislelizumab/Sintilimab) for the Klatskin tumor. Methods: From January 2020 to December 2022, 21 Klatskin tumor patients with malignant hilar biliary obstruction (MHBO) were included. All included patients received biliary decompression by metal stent + Iodine-125 seed strand (ISS) implantation. The number of 125I seeds to be implanted was determined according to the plan of the preoperative computerized treatment planning system (TPS). The procedure-related outcomes were evaluated regarding successful drainage and complications. In addition, the survival of patients who received successful biliary drainage and patients who received sequential systemic anticancer treatment were analyzed. Successful biliary drainage was defined as the serum total bilirubin level dropped by 75% of the preoperative value within 4 weeks. Major complications referred to those that result in death or serious adverse effects including sepsis, uncontrollable biliary or intestinal bleeding, and acute renal failure. The time between stent insertion and death was defined as patient survival. Results: 71.4% achieved successful drainage, significant improvements were observed from before to one month after the procedure in liver function values, including total bilirubin (TBIL), and direct bilirubin (DBIL) (all P&lt;0.001). Minor complications occurred in 5 patients (23.8%) in all patients, including 1 patient (4.8%) who experienced cholangitis, and 4 patients (19%) who suffered abdominal pain. No major procedure-related complication was observed. The median overall survival(mOS) of 21 patients was 6.1 months. Patients who received successful biliary drainage (n=15) had longer mOS than those who received unsuccessful biliary drainage(n=6) [7.4 months vs. 3.5 months, respectively, P&lt;0.001]. Patients who received sequential Lenvatinib+ Pembrolizumab after effective drainage(n=9) had longer mOS than those who only received palliative therapy(n=6) [7.4 months vs. 5.2 months, respectively, P=0.028]. Conclusions: Biliary intervention + ISS combined with the following Lenvatinib+ PD-1 inhibitor is safe and feasible for cholangiocarcinoma patients complicated with obstructive jaundice.

Comparison of Two Types of Guidewires for Malignant Hilar Biliary Obstruction by Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial.

Background: There is insufficient information regarding the optimal guidewire for managing malignant hilar biliary obstruction (MHBO). Therefore, a newly designed 0.025-inch guidewire was compared with the conventional 0.035-inch guidewire for selective cannulation of both intrahepatic ducts (IHDs) in patients with MHBO. Methods: Patients were randomly enrolled into the curved type newly designed 0.025-inch guidewire group (0.025 group) or the curved type conventional 0.035-inch guidewire group (0.035 group). The primary outcome was the selective cannulation rate of IHD. If the assigned guidewire failed to pass the stricture within 5 min, the crossover guidewire was selected. If the crossover guidewire failed to cross the stricture within the next 5 min, it was judged as a failed selective cannulation of both IHDs. Results: A total of 90 patients were enrolled (0.025 group, n = 47; 0.035 group, n = 43). There was no significant difference in baseline characteristics between the groups regarding sex, age, BMI, obstruction level, and clinical presentation. Four patients (8.5%) in the 0.025 group the cannulation of the IHD failed and the conventional 0.035-inch guidewire was substituted in a second attempt; the 0.035-inch guidewire failed to cross the stricture in all four patients. In the 0.035 group, eleven patients (25.6%) failed to achieve selective cannulation of IHD, and the 0.025-inch guidewire was substituted; the newly designed 0.025-inch guidewire crossed the stricture in ten of these (10/11, 90.9%). The selective cannulation rate of IHD was significantly higher in the 0.025 group (95.1% vs. 85.5%, p = 0.043). Conclusions: The 0.025 group exhibited a higher success rate for selective cannulation of both IHDs in MHBO than did the 0.035 group.

Short and long outcomes of endoscopic bilateral metal stent placement for malignant hilar biliary obstruction: Tertiary care oncology centre experience.

Placement of biliary self-expanding metal stents (SEMS) has been effective for palliation of unresectable hilar malignant biliary obstruction. Optimal drainage in hilar obstruction may require placement of multiple stents. Data on multiple SEMS placement in hilar obstruction from India is sparse. Retrospective review of patients with unresectable malignant hilar obstruction who underwent endoscopic bilateral SEMS insertion from 2017 to 2021 was done. Demographic details, technical success and functional success (decrease in the bilirubin value below 3mg/dL at fourweeks), immediate complications with 30-days mortality, requirement of re-intervention, stent patency and overall survival were studied. Forty-three patients were included (mean age 54.9years, 51.2% females). Thirty-six patients (83.7%) had carcinoma gallbladder as primary malignancy. Twenty-six patients (60.5%) were metastatic at presentation. Cholangitis was seen in 4/43 (9.3%). On cholangiogram, 26 (60.4%) had Bismuth type II block, 12 (27.8%) had type IIIA/B, 5 (11.6%) had type IV block. Technical success was achieved in 41/43 (95.3%) patients (38, side-by-side SEMS placement; 3, SEMS-within-SEMS in Y fashion). Functional success was achieved in 39 patients (95.1%). No moderate-severe complications were reported. Median post-procedure hospitalization was five days. Median stent patency was 137days (interquartile range [IQR] 80-214days). Re-intervention was required in four patients (9.3%) after mean 295.7days. Median overall survival was 153days (IQR 108-234days). Endoscopic bilateral SEMS in complex malignant hilar obstruction has good outcomes in the form of technical success, functional success and stent patency. Survival is dismal despite optimal biliary drainage.

A novel controllable cannula with a short flexible tip for reintervention after stent-by-stent placement in malignant hilar biliary obstruction

N/A.

Comparison of the hybrid and partial stent-in-stent method for endoscopic three-segment drainage for unresectable malignant hilar biliary obstruction.

Background and study aims The clinical outcome of the new hybrid drainage method for unresectable malignant hilar biliary obstruction (UMHBO) has not yet been compared with that of the partial stent-in-stent (PSIS) method with three or more stents. Patients and methods Patients with UMHBO underwent drainage of three segments using the hybrid or PSIS method. The clinical outcomes of both methods were compared retrospectively. Results Overall, 54 patients underwent the hybrid (n = 31) or PSIS (n = 23) method of drainage with three or more stents for UMHBO. There were no significant differences in the technical success rate (hybrid vs. PSIS, 87.1 % vs. 87 %), clinical success rate according to per-protocol analysis (81.5 % vs. 70 %), early adverse events rate (14.8 % vs. 10%), late adverse events rate (7.4 % vs. 0 %), and technical success rate of the endoscopic transpapillary reintervention (90.9 % vs. 100 %). Time to recurrent biliary obstruction (TRBO) of the hybrid and PSIS methods was 178 and 231 days, respectively, with no significant difference ( P = 0.354). Conclusions The choice between the two methods should be made at the physician's discretion.