Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a self-expanding metal stent (SEMS) is the gold standard for drainage in case of malignant obstruction of the distal common bile duct (CBD). Nevertheless, 12.5% of these procedures fail. Percutaneous transhepatic biliary drainage (PTBD) is the most frequently used alternative, despite a reported 30-day mortality of 15-20% and morbidity of up to 60%. EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen apposing metal stent (LAMS) is an emerging alternative drainage modality. Data on the long-term outcomes of these alternative techniques are limited. Therefore, this Dutch registry aimed to provide insight in the chosen drainage modality after a failed ERCP-procedure and evaluated the outcomes prospectively.

Aims & Methods

This multicenter investigator-initiated registry included consecutive patients with malignant obstruction of the distal CBD after an unsuccessful ERCP over an inclusion period of 18 months. Patients were treated by either EUS-CDS or PTBD based by discretion of the endoscopist. Follow-up duration was 180 days. Primary endpoints were procedure-related morbidity and mortality within 90 days post-procedure.

Results

In total, 55 patients were included in the registry. EUS-CDS was performed in 44 patients (technical success 98%) and PTBD in 11 patients (technical success 100%). Median post-procedural hospital stay was four days shorter in the EUS-CDS group compared to the PTBD group (1 day (IQR 1-2 days) vs. 5 days (IQR 2-6 days), respectively; p=0.003). Median bilirubin reduction after 30 days was 117.5 µmol/L (IQR 50.3-210.0 µmol/L) in the EUS-CDS group and 102 µmol/L (IQR 83-191 µmol/L) in the PTBD group (p=1.00). Furthermore, LAMS was in place for a median of 85.5 days (IQR 28.5-180 days), while the PTBD needed revision after 21 days (IQR 7-32 days; p=0.001). Procedure-related morbidity after 90 days was 54.5% in the EUS-CDS group and 100% in the PTBD group (p=0.004). In the EUS-CDS group, 37.5% of the patients developed infectious complications and 48.5% non-infectious complications compared to 77.8%, and 72.7%, respectively in the PTBD-group. Additionally, mortality rates within 90 days were higher in the PTBD group (63.6% vs 22.7%; p=0.024).

Conclusion

EUS-CDS is associated with less complications compared to PTBD after a failed ERCP in patients with malignant distal CBD obstruction, as it results in a shorter post-procedural hospital admission and lower morbidity and mortality rates. Although, a randomized controlled trial is needed to confirm this superiority.

Disclosure

Frank P. Vleggaar acts as a consultant for Boston Scientific. Marco J. Bruno received research support from Boston Scientific, Cook Medical, Pentax Medical, Mylan, ChiRoStim and acts as a consultant/lecturer for Boston Scientific, Cook Medical, Pentax Medical and AMBU. Roy L. J. van Wanrooij has a consultancy agreement with Boston Scientific. Peter D. Siersema reports research grants from Pentax and Fujifilm. All outside the submitted work. The other authors have nothing to disclose.

Introduction

Distal malignant biliary obstruction (DMBO) is a serious diagnosis that often results in significant morbidity and mortality due to development of obstructive jaundice and related complications. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been described as a salvage therapy for patients with DMBO following unsuccessful ERCP and/or EUS-guided biliary drainage [1,2]. EUS-GBD leverages the proximity of the gallbladder to the gastrointestinal lumen to establish a new passage for biliary drainage, which offers a viable and potentially safer alternative to current EUS-BD techniques, particularly when the gallbladder is distended [3]. There is a paucity of data reporting on the outcomes of EUS-GBD for this indication, limited by small cohorts an​d single-centre design. We report a multi-centre study of outcomes for EUS-GBD performed for DMBO in non-surgical candidates.

Aims & Methods

A review of a prospectively collected database of 28 EUS-GBD cases was performed between 2017 and 2024 at two referral centres in New Zealand. At both centres, patients were consented for biliary drainage via ERCP, EUS-BD, and/or EUS-GBD prior to sedation so that drainage could be achieved in a single anaesthetic session. Ethics approval was provided at participating centres before commencement. Included participants were adults diagnosed with DMBO who had unsuccessful ERCP and/or EUS-BD, and a patent hepatocystic junction. A transduodenal approach was universal, using electrocautery-enhanced lumen apposing metal stents (LAMS), and propofol-assisted anaesthesia. Technical success (TS), clinical success (CS), length of hospital stay (LOS), adverse events (AEs), reinterventions, and survival were recorded. CS was defined by improvement in biochemistry and symptoms within 72 hours. AEs were categorised into serious and non-serious events. Re-interventions were categorised into early (<7 days) or delayed (≥7 days) procedures. Follow up duration was from time of intervention until patient death.

Results

Mean age was 74 years with 32.1% females. Pancreatic cancer was the most common diagnosis. Mean Charlson comorbidity index was 9.8 ± 1.4 and mean ASA physical status classification was 3.9 ± 0.5. The 10mm LAMS was most commonly used (78.6%), with co-axial plastic stent placement performed in 25%. TS and CS was achieved in all cases. Pre-procedure bilirubin improved from mean 126 ± 115 umol/L to 63 ± 49 umol/L at 72 hours. There were no intra-procedural complications and no early reinterventions recorded. Mean LOS was 3 ± 3 days. There were 9 non-serious AEs, all infective in aetiology and treated with antibiotics. 5 serious AEs were recorded (cholangitis (n=1), recurrent obstruction (n=3) and LAMS obstruction (n=1)) and only these cases required reintervention. These were treated with ERCP (n=1), percutanous drainage (n=3), and stent removal (n=1) respectively. No repeat procedure was required in 23/28 (82.1%) patients. Median cohort survival was 135 days.

Conclusion

EUS-GBD offers excellent TS and CS as a salvage therapy for DMBO in the second or third-line setting. Furthermore, it is safe with a favourable AE profile, short LOS and low rate of reintervention. This is particularly important in this cohort of patients with advanced malignancy. EUS-GBD offers a durable therapy and can be used as destination platform for other DMBO therapeutics. We have also demonstrated feasibility of sequential deployment within the same interventional session as ERCP and EUS-BD procedures creating a streamlined process for limiting cumulative anaesthetic exposures.

References

1. Imai, H., et al., EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. Gastrointestinal endoscopy, 2016. 84(1): p. 147-151.
2. Debourdeau, A., et al., Effectiveness of endoscopic ultrasound (EUS)‐guided choledochoduodenostomy vs. EUS‐guided gallbladder drainage for jaundice in patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography: Retrospective, multicenter study (GALLBLADEUS Study). Digestive Endoscopy, 2024.
3. Kamal, F., et al., Efficacy and safety of EUS-guided gallbladder drainage for rescue treatment of malignant biliary obstruction: A systematic review and meta-analysis. Endoscopic ultrasound, 2023. 12(1): p. 8-15.

Introduction

Endoscopic biliary drainage for malignant obstruction can be technically challenging, particularly in patients with high-grade hilar strictures or progressive distal lesions that extend beyond the reach of ERCP alone. While ERCP remains the first-line approach, it may prove inadequate in complex scenarios. Endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative or complementary technique. However, data on outcomes that combine ERCP and EUS-BD in routine clinical practice remain insufficient and limited.

Aims & Methods

This study aims to evaluate the clinical success, stent patency, and complication rates of combined ERCP and EUS-BD in patients with malignant biliary obstruction while identifying factors associated with complications. We included 40 patients who underwent combined ERCP and EUS-BD for malignant biliary obstruction at a tertiary center from March 2020 to March 2025. The patients were divided into two groups: one-session procedures, in which both techniques were performed during the same session (n=14), and staged procedures, where EUS-BD was followed by at least one prior ERCP (n=26). Clinical success was defined as resolving jaundice and/or cholangitis without additional drainage. The outcomes assessed included clinical success, stent patency, complications, and reintervention. Univariate analysis was employed to identify predictors of complications.

Results

The cohort included 21 (52.5 %) males and 19 (47.5%) females, with a median age of 65.6 years. The distribution of strictures was as follows: 23 (57.5%) high-grade hilar (Bismuth III/IV), 7 (17.5%) Bismuth I/II, and 10 (25%) distal. Underlying malignancies included 12 (30%) hilar cholangiocarcinoma, 8 (20%) pancreatic adenocarcinoma, and 16 (40 %) liver or hilar metastasis from other tumors.
Clinical success was achieved in 90% of patients (36/40), with no significant difference between one-session and staged groups (85.7% vs. 92.3%, p=0.60). The median procedural time was 39.3 minutes. Overall, 12 patients (30%) experienced complications, including stent-related infections in 10 (25%), post-ERCP pancreatitis in 1(2.5%), and bleeding in 1 (2.5%). Complication rates were similar between the one-session and staged groups (28.6% vs. 31.0%, p=1.00). Reintervention was required in 3 patients (7.5%). A significant association was observed between undergoing more than two prior ERCPs and the risk of complications (66.7% vs. 22.6%, p=0.038). Neither the presence of hilar strictures (p=0.56) nor procedural timing (one-session vs. staged; p=1.00) was significantly associated with increased complications.

Conclusion

Combining ERCP and EUS-guided biliary drainage is a safe and effective strategy for managing malignant biliary obstruction, including complex hilar and progressive distal strictures. Performing both procedures in a single session does not increase complication rates and may provide comparable clinical success. The number of prior ERCPs was the only significant predictor of complications, suggesting a potential benefit from earlier use of EUS-BD in selected patients. Further prospective studies are warranted to confirm these findings and guide treatment algorithms for complex biliary obstruction.

Introduction

Acute cholecystitis (AC) is a relatively frequent complication of ERCP with placement of self-expandable metal stents (SEMS) for distal malignant biliary obstruction (DMBO). SEMS design seems irrelevant, whereas neoplastic Cystic duct infiltration (CDI) has been claimed to be the most important independent predictor. However, data regarding incidence and risk factors are scant.

Aims & Methods

The primary aim of this study was to evaluate the incidence and risk factors of AC following ERCP with SEMS placement in patients with DMBO clustered according to the presence or absence of CDI evaluated by EUS.
This is a single tertiary center prospective study conducted between Feb-2024 and Jan-2025. All consecutive patients candidate to EUS and ERCP for characterization and endoscopic treatment of DMBO treated with a partially covered SEMS were included in the study (ClinicalTrials.gov identifier NCT04813055).
Two independent endosonographers blindly assessed the presence of CDI and other morphological risk factors (such as cholelithiasis or cholecystitis) at EUS.
Two independent endoscopists estimated CD coverage by the SEMS and other risk factors (such as gallbladder cannulation and contrast opacification) at ERCP.
Clinical outcomes were evaluated by one independent assessor during admission, at 30 days and then every 60 days.
The primary outcome was the onset of AC among patients with and without CDI. Risk factors for AC were evaluated through multivariate logistic regression model.

Results

A total of 109 patients with DMBO were included (median age 71 [IQR 62-77], female 38.5%, pancreatic adenocarcinoma 87.2%).
At EUS, prevalence of CDI was 16.5%; gallstones and sludge were present in 6.4% and 73.4% of cases.
At ERCP, where a 6-cm and 4-cm SEMS were used in 64.2% and 34% of cases, the CD was covered by the SEMS in 40.7% of the procedures.
Median follow-up was 94 [35-175] days.
Seven (6.4%) patients experienced post-ERCP pancreatitis whereas 8 (7.3%) experienced post-ERCP AC, after a median time of 6.5 [5-31] days post-procedure. AC required additional intervention in 57.1% of cases.
The rate of post-ERCP AC did not differ between patient with and without CDI, being 11.1% versus 6.6%, p=0.503.
Amongst patients with AC, ASA scores were lower while placed SEMS were longer, and the rate of CD coverage was significantly higher (87.5% versus 37%, p=0.005); the rate of CDI was higher but the difference was not significant.
At multivariate analysis, CD coverage by the SEMS was the only independent predictor of post-ERCP AC (OR[95% CI] = 13.8 [1.5-123.6].

Conclusion

In the context of SEMS placement for DMBO, post-ERCP AC is relatively more frequent than post-ERCP pancreatitis. EUS ahead of ERCP can help in predicting morphological risk factors for this event.
Coverage of the cystic duct by the SEMS appears to be the most important predictor, independent of cystic duct infiltration, potentially proposing a new high-risk group for this event, to be validated in future studies.

Introduction

Malignant distal biliary obstruction is a common complication in the progression of pancreatic tumors. Endoscopic ultrasound (EUS) guided drainage can provide effective biliary drainage when not achieved by endoscopic retrograde cholangiopancreatography (ERCP) and can be performed by hepaticogastrostomy or choledocoduodenostomy (CDD). Gallbladder drainage by cholecystogastrostomy (GBD) has been described in small uncontrolled series and could be effective. The objective of this study was to compare the clinical efficacy of CGD vs CDD in distal biliary tract obstruction (DBTO).

Aims & Methods

This was a retrospective, multicenter study (four tertiary centers) including all consecutive patients with DBTO and jaundice who underwent CDD or GBD with a lumen-apposing metal stent (LAMS). The primary outcome was to compare the clinical success rate defined as a decrease of total bilirubin by 50% in 14 days and/or a decrease in total bilirubin below 51 µmol/L after 30 days. Secondary outcomes were technical success, overall survival, survival without biliary reintervention, immediate (within 24 hours) and delayed (>24 hours) morbidity.

Results

78 patients were included between July 2018 and September 2022, 41 GBD and 37 CDD. The mean age was 71 years, and 82% had pancreatic adenocarcinoma, 55% had metastatic disease at diagnosis, and 45% had duodenal stenosis. Most patients (N=59; 76%) had undergone EUS-guided drainage after ERCP failure. The mean diameter of the main bile duct was significantly smaller in the CGD group (13 mm vs. 18 mm; p=0.001). The total bilirubin mean was 196 µmol/L in the GBD group vs. 241 µmol/L in the CDD group; p=0.149. Clinical success was comparable between the two groups: 88% (36/41 - CGD) vs. 89.2% (33/37 - CDD); p=0.848. There was no difference in overall survival (log-rank p=0.727) or survival without biliary obstruction (log-rank p=0.725) between the two groups. Immediate morbidity was comparable: 7% (3/41 - GBD) vs. 13% (5/37 - CDD); p=0.368. The rate of significant immediate complications tended to be lower in the GBD group (5% (2/41 - CGD) vs. 8% (3/37 - CDD); p=0.093). Delayed morbidity (mainly LAMS obstruction) (>24 hours) was lower in the GBD group 7.3% (3/41 - CGD) vs. 27% (10/37 - CDD); p=0.022. There were no biliary complications after the 26th day in the GBD group. The LAMS dimensions did not have an impact on biliary complications in the CGD group (6x8mm vs. 10x10mm vs. 15x10mm).

Conclusion

Biliary drainage of tumoral obstruction of the distal biliary tract by GBD had comparable clinical efficacy and was associated with reduced delayed morbidity compared to CDD. This type of drainage is feasible, especially when the main bile duct is not dilated enough to consider CDD.

References

Maire F, Hammel P, Ponsot P, Aubert A, O’Toole D, Hentic O, et al. Long-term outcome of biliary and duodenal stents in palliative treatment of patients with unresectable adenocarcinoma of the head of pancreas. Am J Gastroenterol. 2006 Apr;101(4):735–42.
van der Merwe SW, van Wanrooij RLJ, Bronswijk M, Everett S, Lakhtakia S, Rimbas M, et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Feb;54(2):185–205.
Issa D, Irani S, Law R, Shah S, Bhalla S, Mahadev S, et al. Endoscopic ultrasound-guided gallbladder drainage as a rescue therapy for unresectable malignant biliary obstruction: a multicenter experience. Endoscopy. 2021 Aug;53(8):827–31.

Introduction

Endoscopic removal of common bile duct stones (CBDS) via endoscopic retrograde cholangiopancreatography (ERCP) is the first-line treatment. In developed countries, the number of ERCP procedures for CBDS in elderly patients is increasing with the aging population. Elderly patients often present with poor performance status (PS), are frequently on antithrombotic therapy, and have multiple comorbidities. These factors raise concerns about an increased risk of ERCP-related complications; however, the safety and efficacy of ERCP in this population have not been fully evaluated.

Aims & Methods

The aim of this study was to assess the outcomes of ERCP for CBDS in elderly patients. Among 548 patients with symptomatic CBDS treated at our institution between April 2017 and February 2024, we excluded 81 cases involving altered anatomy, use of endosonography-assisted rendezvous technique, spontaneous stone passage, and biliary pancreatitis. The remaining 467 patients undergoing ERCP at our institution were retrospectively analyzed. The patients were divided into an elderly group (E group: ≥75 years, n=241) and a younger group (Y group: <75 years, n=226), and short- and long-term outcomes were compared between the two groups.

Results

Patient Characteristics: The median age was 81 years (range: 75–99) in the E group and 68 years (range: 21–74) in the Y group. Male sex was less frequent in the E group (55% vs. 68%, p=0.006). The E group had significantly higher rates of antithrombotic use (39% vs. 24%, p=0.001), American Society of Anesthesiologists physical status ≥ III (57% vs. 35%, p=0.001), and concomitant cholangitis (52% vs. 41%, p=0.012). Median stone size was slightly larger in the E group (8 mm vs. 6 mm, p=0.14), and the median bile duct diameter was significantly wider (10 mm vs. 9 mm, p=0.001). Comorbidities were more prevalent in the E group: cardiovascular disease (34% vs. 22%, p=0.004), hypertension (52% vs. 39%, p=0.004), malignancy (33% vs. 18%, p=0.001), and dementia (11% vs. 2%, p=0.001). Although endoscopic sphincterotomy (EST) was the most common papillary intervention in both groups, endoscopic papillary large balloon dilation (EPLBD) was more frequently performed in the E group (31% vs. 10%).Lithotripsy rates were similar between groups (22% vs. 16%, p=0.2).
Outcomes: Complete stone removal was achieved in 96% of the E group and 98% of the Y group (p=0.2). The median number of treatment sessions was 1 in both groups (range: 1–3, p=0.13). Overall complication rates were comparable (8% vs. 7%, p=0.63). In the E group, complications included pancreatitis (n=15), bleeding (n=5), perforation (n=1), and aspiration pneumonia (n=1); in the Y group, pancreatitis (n=10) and bleeding (n=5) were observed. No procedure-related mortality occurred in either group. There was no significant difference in the cumulative recurrence rate of stones after complete removal (p=0.29). Multivariate analysis using variables such as age, sex, presence of cholangitis, bile duct diameter, lithotripsy, and gallbladder stones revealed no definite predictors of recurrence.

Conclusion

Although recent studies have reported the potential utility of long-term biliary stenting in elderly patients, stent occlusion leading to cholangitis remains a concern. Repeated hospitalizations in elderly patients can decrease activities of daily living. Therefore, we prioritize complete stone removal in patients with a favorable long-term prognosis. This study demonstrates that even in patients aged 75 years and older, active treatment of CBDS via ERCP might be effective and safe.