Malignant Biliary Obstruction Research Articles

Metal stent versus plastic stent in endoscopic ultrasound-guided hepaticogastrostomy for unresectable malignant biliary obstruction: Large single-center retrospective comparative study.

Whether metal stents (MS) or plastic stents (PS) yield better outcomes for malignant biliary obstruction in endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is controversial. We aimed to compare outcomes of initial EUS-HGS performed with MS or PS. In this single-center retrospective study, we included patients (MS/PS groups: n = 151/72) with unresectable malignant biliary obstruction and performed multivariable analysis. The landmark date was defined as day 100 and used to evaluate the time to recurrent biliary obstruction (TRBO). The clinical success rate was similar in both groups. The mean total bilirubin percentage decrease at week 2 was significantly higher in the MS group than in the PS group (-45.1% vs. -23.7%, P = 0.016). Median TRBO was significantly different between the MS and PS groups (183 and 92 days, respectively; P = 0.017). TRBO within 100 days was comparable in both groups but was significantly shorter only after 100 days in the PS group (adjusted hazard ratio 12.8, P < 0.001). Adverse events were significantly more common in the MS group (23.8% vs. 9.7%, P = 0.012), although they occurred relatively frequently even with PS in the cholangitis subgroup (Pinteraction = 0.034). After endoscopic re-intervention, TRBO tended to be longer with revision PS (hazard ratio 0.40, P = 0.47). Although MS provided early improvement of jaundice and long stent patency, PS provided a better safety profile and comparable stent patency until 100 days. PS might also be an adequate and optimal palliation method in EUS-HGS.

HPB SO49 - EUS guided biliary drainage prior to pancreaticoduodenectomy - The Leeds experience

Abstract Background Biliary obstruction is a common manifestation of biliary tract cancer. Decompression is indicated if patients develop systemic illness due to the obstruction or to facilitate chemotherapy. Stent insertion via ERCP is the current first line decompressive technique, although in certain situations such as duodenal/ampullary obstruction, is not always feasible. When ERCP has failed, our centre has implemented using lumen apposing metallic stents (LAMS) delivered by the HOT AXIOS™ system to create a draining choledochoduodenostomy. Our aim is to report on our experience of carrying out pancreaticoduodenectomy after biliary drainage has been achieved with this technique. Method All patients who underwent biliary drainage with a LAMS and then surgical resection of a biliary tract cancer were identified from a prospective database. Both procedures were carried out at St James’s Hospital, Leeds, between June 2018 and May 2024 by expert gastroenterology and pancreatic surgical consultants. Procedural and inpatient notes were retrospectively reviewed. The primary outcomes were the assessment of technical feasibility of pancreaticoduodenectomy and of perioperative complications, classified by the Clavien-Dindo (CD) system. Secondary outcomes were the safe and clinically effective (defined as &amp;gt;50% reduction of serum bilirubin within 7 days) application of LAMS. Results Thirteen patients were identified with a median age of 69 (51-81), twelve requiring drainage due to jaundice and one due to cholangitis. Duration to resection was median 68 days (12-377). Surgical resection was successful in all thirteen patients, in seven cases the surgeons commented on fibrosis due to the stent, with one qualifying that this was no more than a conventional biliary stent. Postoperatively five patients had no complications, one CD grade 1, five CD grade 2 and one CD grade 5. There were no significant post endoscopic complications and 10 patients demonstrated clinical effectiveness of the LAMS. Conclusion ERCP is the current first line method of drainage in malignant biliary obstruction. Technical success is reliant on unimpeded access to the bile duct. The HOT AXIOSÔ system circumvents this reliance by delivering a LAMS in a single stage forming a draining choledochoduodenostomy. Our centre’s experience suggests that it is a safe and effective method of biliary drainage which does not impede surgical resection. Additionally, it is not associated with the risk of post procedural pancreatitis. Our experience justifies further large-scale studies into this technique with consideration for its use not only when ERCP is not possible.

Suprapapillary trisectoral deployment of slim fully covered metal stents with ultra-stiff high-sliding guidewires for malignant hilar biliary obstruction.

Suprapapillary trisectoral deployment of slim fully covered metal stents with ultra-stiff high-sliding guidewires for malignant hilar biliary obstruction.

Novel specialized guidewire for bridging deployment into the right hepatic duct via endoscopic ultrasound-guided hepaticogastrostomy for malignant hilar biliary obstruction.

Novel specialized guidewire for bridging deployment into the right hepatic duct via endoscopic ultrasound-guided hepaticogastrostomy for malignant hilar biliary obstruction.

Endoluminal radiofrequency ablation with stenting versus stenting alone in patients with malignant biliary obstruction: a meta-analysis of randomized trials.

Endoluminal radiofrequency ablation (RFA) is a palliative treatment for patients suffering from malignant biliary obstruction (MBO). We aimed to conduct a meta-analysis to evaluate the impact of RFA on stent patency, patient survival, and adverse events. Major databases were searched through December 2023 for patients who had undergone stenting with or without RFA for extrahepatic MBO. A random-effects model was used for analysis, with results expressed as relative risk ratios (RRs) with 95%CIs. Nine RCTs involving 750 subjects with MBO (374 RFA plus stent vs. 376 stent only) were included. Meta-analysis revealed similar risks of stent patency at 3 months (RR 1.01, 95%CI 0.92-1.11; I 2 = 4%) for RFA plus stenting vs. stent only. Meta-analysis showed improved survival at 6 months (RR 0.84, 95%CI 0.73-0.96; I 2 = 21%; P = 0.01) for RFA plus stenting vs. stent only. Subgroup analysis comparing plastic vs. uncovered metal stents showed that stent patency was unaffected at 3 months (RR 1.06, 95%CI 0.91-1.23; I 2 = 17%). Subgroup analysis showed that patients with cholangiocarcinoma experienced an overall survival benefit with RFA plus stenting vs. stenting alone (P < 0.001); however, stent patency remained unaffected (P = 0.08). An increased incidence of cholecystitis was noted with RFA plus stenting vs. stenting alone (5.1% [95%CI 3.1%-7.8%] vs. 0.3% [95%CI 0.01%-1.5%], respectively). Combining endoluminal RFA and stenting may improve overall survival in patients with MBO. RFA did not significantly impact stent patency.

Stent misdeployment and factors associated with failure in EUS-guided choledochoduodenostomy: an analysis of the combined datasets from the ELEMENT and DRA-MBO trials.

Stent misdeployment (SMD) is a feared technical challenge of EUS-guided choledochoduodenostomy using a lumen apposing stent (EUS-CDS) that has been poorly characterized. We aim to ascertain the rate of SMD in EUS-CDS for malignant distal biliary obstruction (MDBO) and describe its outcomes while identifying variables associated with its occurrence. In addition, we aim to propose a de novo SMD classification. A post hoc analysis of two RCTs comparing EUS-CDS vs. endoscopic retrograde cholangiopancreatography in MDBO. The main endpoint was the rate of SMD classified as misdeployment of the distal flange (type I), proximal flange (type II), contralateral bile duct wall injury (type III), or double mucosal puncture (type IV). A multivariable analysis was performed to identify variables associated with the odds of SMD and/or technical failure and clinical failure or stent dysfunction. 152 patients were included with a technical success of 93.4%. SMDs occurred in 11 (7.2%) patients (95% CI, 3.1%-11.4%): 8 type I, 1 type II, and 2 type III. Endoscopic salvage was successful in 81.8%. SMDs led to an adverse event (AE) in 4 cases (2 mild and 2 moderate) with an overall AE rate of 2.6% (95% CI, 0.7%-6.6%). On multivariable analysis, an extrahepatic bile duct diameter of ≤ 15 mm was associated with increase odds of SMD and/or technical failure. SMD is relatively common in EUS-CDS and is associated with an extra-hepatic bile duct diameter measuring ≤ 15 mm. The majority of SMDs can be rescued endoscopically with low risk for AE.

Usefulness of a dedicated laser-cut metal stent with an anchoring hook and thin delivery system for endoscopic ultrasound-guided hepaticogastrostomy in malignant biliary obstruction: a prospective multicenter trial (with video).

Background and AimsEUS-guided hepaticogastrostomy (EUS-HGS) carries a risk of serious adverse events (AEs). A newly designed, partially covered laser-cut stent with antimigration anchoring hooks and a thin tapered tip (7.2F), called a Hook stent, has been developed to prevent serious AEs associated with EUS-HGS. The present prospective multicenter clinical trial evaluated the efficacy and safety of the Hook stent for EUS-HGS after failure of ERCP in patients with unresectable malignant biliary obstruction. MethodsThe primary endpoint was the rate of clinical success, and the secondary endpoints were the rates of technical success, AEs, recurrent biliary obstruction (RBO), procedure success without using a tract dilation device, re-intervention for RBO, time to RBO (TRBO) and overall survival (OS). ResultsA total of 38 patients underwent EUS-HGS using the Hook stent. Its technical and clinical success rates in patients undergoing EUS-HGS were 100% and 92.1%, respectively. The procedure success rate without using a tract dilation device was 94.7%. Four (10.5%) patients developed early AEs, but there were no severe AEs such as stent migration. RBO developed in 26.3% of patients. Re-intervention for RBO had a 100% success rate. The median TRBO was not reached, and the median OS was 191 days. ConclusionsEUS-HGS using the Hook stent demonstrated a high clinical success rate, a low rate of early AEs, and an acceptable stent patency. The Hook stent is safe and feasible for use in patients undergoing EUS-HGS.

Secondary uncovered versus fully-covered metal stents for the management of occluded stent in unresectable distal malignant biliary obstruction

IntroductionSelf-expandable metallic stents (SEMS) have been widely placed for unresectable distal malignant biliary obstruction (UDMBO). However, the dysfunction rate is 19–40% and its treatment is controversial. We aimed asses the efficacy and safety of a secondary biliary stents (uncovered (UC) versus fully-covered (FC) stent) for the management of occluded SEMS. Patients and methodsBetween 2015 and June 2023, 41 patients with UDMBO underwent secondary biliary stent placement as “stent-in-stent” (20 FCSEMS and 21 UCSEMS). The primary outcomes were technical and clinical success of SEMS placement. Secondary outcomes included adverse events (AEs), patency and survival. Patients were prospectively followed until death or loss of follow-up. ResultsTechnical (100% vs 85.5%) and clinical (100% vs 95.2%) success rates were similar in FCSEMS and UCSEMS groups. The median follow-up period was 510 days (range 290–630). The median duration of stent patency of FCSEMS (220 days, IQR 137.5–442.5) was longer than UCSEMS (150 days, IQR 110–362.5) (P=0.395), although stent dysfunction within 6 months was not different between groups. Multivariate analysis indicated that sex (HR=0.909, 0.852–0.970), antitumor treatment (HR=0.248, 0.032–0.441), stent patency (HR=0.992, 0.986–0.998) and clinical success (HR=0.133, 0.026–0.690) were significant factors for overall survival. There were no remarkable differences in AEs. ConclusionsThe placement of additional biliary stent using the stent-in-stent method is an effective and safe rescue treatment for patients with UDMBO and occluded stent. In addition, the use of FCSEMS compared UCSEMS has unclear benefits regarding stent patency and overall survival.

A retrospective comparative study of biliary drainage using balloon endoscopy and endoscopic ultrasound for malignant obstruction in patients with surgically altered anatomy.

Endoscopic biliary drainage for malignant biliary obstruction (MBO) in patients with surgically altered anatomy is challenging, and technical difficulty could differ by the anatomy. Balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP) and endoscopic ultrasonography-guided biliary drainage (EUS-BD) are both emerging procedures, and we conducted the single-center, retrospective study to compare clinical outcomes of BE-ERCP and EUS-BD for MBO. Consecutive patients with surgically altered anatomy who underwent BE-ERCP or EUS-BD for MBO were retrospectively studies. Technical and clinical success rates, adverse events (AEs), and time to recurrent biliary obstruction (TRBO) were compared. Patient characteristics were comparable between BE-ERCP (n = 118) and EUS-BD (n = 32), other than more patients with hepaticojejunostomy in the BE-ERCP group (66% vs. 44%, P = 0.03). Technical success rate was significantly higher in the EUS-BD group (70% vs. 94%, P = 0.005), but clinical success rates (84% vs. 90%, P = 0.55), early AE (14% vs. 22%, P = 0.29) and late AE rates (42% vs. 38%, P = 0.84), and RBO rates (31% vs. 34%, P = 0.67) were comparable between the groups. TRBO was 170 and 206days in the BE-ERCP and EUS-BD group (P = 0.37). In the subgroup analysis of patients with the intact papilla, the technical success rate of BE-ERCP was as low as 55%, compared to 94% in EUS-BD (P = 0.003). EUS-BD was associated with higher technical success rate than BE-ERCP for MBO in patients with surgically altered anatomy.

Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial

BackgroundEndoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS...

Novel self-expandable metallic stent with dumbbell-shape and spiral outer cover for malignant distal biliary obstruction.

Novel self-expandable metallic stent with dumbbell-shape and spiral outer cover for malignant distal biliary obstruction.

Feasibility of Double-Deployment Small-Diameter Covered Metallic Stent for Malignant Distal Biliary Obstruction (with Video)

Background/Objectives: Covered self-expandable metallic stents (CSEMS) are commonly used to treat malignant distal biliary obstructions. A 10-mm CSEMS carries the risk of obstructing the pancreatic and cystic duct orifices by adhering to the bile duct; therefore, postoperative pancreatitis and cholecystitis are reported to occur at a certain frequency. We have adopted a new drainage technique for malignant distal biliary obstruction called ‘‘double-slim SEMS stenting” (DSS), where two small-diameter CSEMS are placed side-by-side. We aimed to compare the efficacy and safety of biliary drainage using DSS with those of conventional CSEMS. Methods: In total, 50 patients who underwent endoscopic biliary drainage for malignant distal biliary obstructions between April 2019 and March 2022 at Hyogo Medical University Hospital were enrolled. Patients were divided into DSS and Conventional groups, and the technical success rate, clinical success rate, adverse events, success rate for reintervention, recurrent biliary obstruction (RBO) rate, and time to RBO (TRBO) were evaluated. Results: There were no significant differences in patient characteristics between the DSS (n = 20) and Conventional groups (n = 30). The technical and clinical success rates were 100% in the DSS group. The incidence of adverse events was not significantly different between the two groups (DSS/Conventional: 10.0% [2/20]/20.0% [6/30]) (p = 0.34). No acute cholecystitis was observed in the DSS group. The incidence rates of RBO were 30% (6/20) and 43% (13/30) in the DSS and Conventional groups, respectively (p = 0.92). The median TRBO in the DSS group was 378 days, while the TRBO in the Conventional group was 195 days (p = 0.03), resulting in significantly longer TRBO in the DSS group. Conclusions: DSS emerges as a viable and safe approach for biliary drainage in malignant distal biliary obstruction, demonstrating a lower incidence of adverse events and longer TRBO compared to conventional CSEMS.

Palliation of Gastric Outlet Obstruction in Case of Biliary Obstruction-A Retrospective, Multicenter Study: The B-GOOD Study.

EUS-guided gastroenterostomy (EUS-GE) is a novel and effective procedure for the management of malignant gastric outlet obstruction (GOO) with more durable results when compared to enteral stenting (ES). However, data comparing EUS-GE to ES in patients already treated with EUS-guided choledocoduodenostomy (EUS-CDS) for distal malignant biliary obstruction (DMBO) are lacking. We aimed to compare outcomes of EUS-GE and ES for the palliation of GOO in this specific population of patients. A multicenter, retrospective analysis of patients with DMBO treated by EUS-CDS and subsequent GOO treated by EUS-GE or ES from 2016 to 2021 was conducted. Primary outcomes were overall AEs rate and dysfunction of the EUS-CDS after GOO treatment. Secondary outcomes included clinical success, technical success, procedure duration, length of hospital stay and relapse of GOO symptoms. A total of 77 consecutive patients were included in the study: 25 patients underwent EUS-GE and 52 underwent ES. AEs rate and patency outcomes of the EUS-CDS after GOO treatment were comparable between the two groups (12.5% vs. 17.3%; p = 0.74). No recurrence of GOO symptoms was registered in the EUS-GE group while 11.5% of ES patients had symptoms recurrence, even if not statistically significant (p = 0.16), after a mean follow-up period of 63.5 days. EUS-GE and ES are both effective and safe for the palliation of GOO in patients already treated by EUS-CDS for DMBO with no difference in the biliary stent dysfunction rate and overall AEs. EUS-GE is associated with less recurrence of GOO symptoms.

S25 Biliary Stenting With and Without Endoscopic Sphincterotomy in Patients With Malignant Biliary Obstruction: Meta-Analysis of Randomized Controlled Trials

S25 Biliary Stenting With and Without Endoscopic Sphincterotomy in Patients With Malignant Biliary Obstruction: Meta-Analysis of Randomized Controlled Trials

S1617 Post-ERCP Cholecystitis Following Covered Self-Expandable Metal Stent Placement in Patients With Malignant Biliary Obstruction: A Meta-Analysis

S1617 Post-ERCP Cholecystitis Following Covered Self-Expandable Metal Stent Placement in Patients With Malignant Biliary Obstruction: A Meta-Analysis

Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study

Background and AimsBiliary drainage by endoscopic retrograde cholangiography (ERCP) in patients with malignant distal bile duct obstruction (MBO) is frequently associated with complications, such as pancreatitis, hampering patient outcome. EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) is a promising alternative in patients with MBO but is associated with a worrisome risk of stent dysfunction. Placement of a fully covered self-expandable metal stent (FCSEMS) through the LAMS, thereby changing the axis of biliary drainage towards the descending duodenum, may decrease the risk of stent dysfunction while maintaining high technical success and low adverse event rates. MethodsProspective single center pilot study in patients with a pathology confirmed MBO without gastric-outlet obstruction. Primary outcome was stent dysfunction, defined as recurrent jaundice after initial clinical success, ongoing jaundice in combination with persistent bile duct dilatation, or cholangitis. The study was registered in clinicaltrials.gov (registry number NCT05595122). ResultsOverall, 27 consecutive patients eligible for EUS-CDS were enrolled. The placement of a LAMS was successful in 24/27 patients (89%), and placement of FCSEMS through the LAMS was successful in 20/24 (83%), in the remaining 4 patients a coaxial double-pigtail plastic stent was placed. In 2 of these 20 patients there was persistent jaundice requiring stent revision (10%), leading to a clinical success rate of 90%. No patients developed stent dysfunction after initial clinical success. ConclusionsThis study showed a stent dysfunction rate of 10% following technically successful EUS-CDS with placement of a FCSEMS through the LAMS. Improving the design of LAMS may further reduce the rate of stent dysfunction.

S1658 Risk Factors for Cholecystitis After Self-Expandable Metallic Stent Placement for Malignant Distal Biliary Obstruction: A Systematic Review and Meta-Analysis

S1658 Risk Factors for Cholecystitis After Self-Expandable Metallic Stent Placement for Malignant Distal Biliary Obstruction: A Systematic Review and Meta-Analysis

Efficacy and safety of endoscopic ultrasonography (EUS) hepaticogastrostomy (HGS) versus choledochoduodenostomy (CDS) in ERCP-failed malignant biliary obstruction: A systematic review and META-analysis.

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard in managing malignant biliary obstruction. The success of ERCP has limitations, whereas surgical biliary bypass and percutaneous transhepatic approaches, as alternative modalities, come with significant costs, longer durations, and higher levels of mortality and morbidity. Endoscopic ultrasonography (EUS)-guided biliary drainage with two approaches, hepaticogastrostomy (EUS-HGS) and choledochoduodenostomy (EUS-CDS), is a favored and evolving alternative modality. This study aims to compare the efficacy and safety of EUS-HGS and EUS-CDS. We conducted a systematic review and meta-analysis by searching PubMed, ScienceDirect, Cochrane Library, and Scholar databases up to August 2023, based on the 2020 PRISMA guidelines. We identified randomized and nonrandomized studies comparing the efficacy and safety of EUS-HGS and EUS-CDS. Outcome measures included technical and clinical success, side effects, and mean procedure time. Nine nonrandomized studies and two randomized controlled trials involving 537 patients (225 EUS-HGS, 312 EUS-CDS) were analyzed. No difference was found in technical success (OR, 0.83; 95% CI, 0.41-1.68; I 2 = 0%) and clinical success between the two procedures (OR, 0.96; 95% CI, 0.51-1.81; I 2 = 9.94%). Side effects were significantly higher in EUS-HGS (OR, 2.01, 95% CI, 1.14-3.59; I 2 = 0%). No significant difference in mean procedure time was observed between the two procedures (0.13; 95% CI, -0.15-0.41; I 2 = 34.89%). There are differences in efficacy and safety between EUS-HGS and EUS-CDS. EUS-CDS has a faster procedure time, lower risk of side effects, and ease of puncture during the procedure.

S4060 Case Series of EUS-Guided Biliary Drainage for Malignant Biliary Obstruction at a Community Hospital

S4060 Case Series of EUS-Guided Biliary Drainage for Malignant Biliary Obstruction at a Community Hospital

Risk factors for acute pancreatitis after endoscopic retrograde cholangiopancreatography: a retrospective single-center study

Background. Endoscopic retrograde cholangiopancreatography (ERCP) is an important procedure in the diagnosis and management of pancreaticobiliary diseases. Post-ERCP pancreatitis (PEP) is the most common and serious adverse event after ERCP. Purpose – to evaluate retrospectively PEP incidence and to identify independent risk factors of PEP. Materials and Methods. The analysis of 578 ERCP cases was done. A number of potential risk factors for PEP were taken into uni- and multivariate analisys: age, gender, common bile duct (CBD) size, bilirubin level, presence of cholangitis, Sphincter of Oddi dysfunction (SOD), malignant biliary obstruction, chronic pancreatitis, biliary obstruction, history of cholecystectomy, history of endoscopic papillosphincterotomy (EPST), initial ERCP success, therapeutic success, selective biliary cannulation, pancreatic cannulation/injection, Precut and EPST. Results. PEP was in 29 (5%) cases. Six factors with р &lt; 0,05 by univariate analysis (CBD ≤ 10 mm, normal bilirubin level, SOD, history of cholecystectomy, pancreatic cannulation/injection, precut) were included into multivariate logistic regression model. The independent risk factor for PEP were CBD ≤ 10 mm (OR 2,416; 95% ДІ, 1,037–5,629; p = 0,041), SOD (OR 4,107; 95% ДІ, 1,726–9,771; p = 0,001) та pancreatic cannulation/injection (OR 3,447; 95% ДІ, 1,455–8,166; p = 0,005); and precut was an independent protective factor for PEP (OR 0,129; 95% ДІ, 0,047–0,354; p = 0,014). Conclusions. The incidence of PEP was 5%. Small CBD and SOD are independent PEP risk factors as well as pancreatic cannulation/injection. Early precut technique is an independent factor preventing PEP.