Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) in patients with malignant distal biliary obstruction (MBO) is associated with a 75-94% technical success rate and up to 3-18% pancreatitis rate.(1-5) Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) potentially results in higher technical success without the risk of pancreatitis. However, currently available prospective studies regarding EUS-CDS instead of ERCP used self-expandable metal stents (SEMS), while single step lumen-apposing metal stents (LAMS) may simplify the procedure and improve outcome.

Aims & Methods

Aim of this single-centre prospective pilot study was to assess the effectiveness and safety of EUS-CDS using LAMS as primary drainage strategy in MBO. Patients with a proven MBO and bile duct diameter of at least 12mm who required biliary drainage were included, excluding patients with gastric outlet obstruction. Patients underwent EUS-CDS using a 6x8mm LAMS. Primary outcome was technical success confirmed by a cholangiogram. Secondary outcomes were clinical success, defined as 50% decrease of bilirubin or relieve of symptoms after technical success without re-intervention, procedure time, adverse events (AEs) and re-interventions within 6 months.

Results

Overall, 22 patients were enrolled (median age 69.5 years [IQR 64-75.25], 7 male [32%]). The majority was diagnosed with pancreatic ductal adenocarcinoma (n=20, 91%). All tumor stages were included (10 resectable, 6 locally advanced, 6 metastatic). Patients had a median bile duct diameter of 16 mm (IQR 13-20) and median bilirubin level of 225 µmol/L (IQR 130.75-335.25) prior to the intervention.
Technical success was achieved in 20/22 patients (91%). In one patient the stent was unintentionally placed in the cystic duct requiring a successful second EUS-CDS procedure. In the second patient the stent was maldeployed in the bile duct wall and ERCP was performed in the same procedure. Median procedure time was 11 minutes (IQR 7-16). Clinical success was achieved in 18/20 patients (90%). In the 2 remaining patients adequate biliary drainage was later achieved after additional placement of a double pigtail stent (DPS) through the LAMS.
Except for the described endoscopically treated perforation, no periprocedural adverse events occurred. Eight patients (36%) experienced a possible related adverse event within 30 days after stent placement. Six patients developed cholangitis which was considered stent dysfunction. One patient had mild intermittent abdominal pain which resolved after placement of a DPS through the LAMS and one patient developed rhabdomyolysis and kidney failure of unknown relation to the procedure which completely resolved. One patient died within 30 days due to fulminant disease progression which was considered unlikely related to the procedure.
Eleven patients (55%) experienced stent dysfunction within 6 months, presenting with either cholangitis (n=10) or jaundice (n=1). In 2 patients cholangitis was sufficiently treated with antibiotics while 9 patients needed a re-intervention.

Conclusion

The present study supports the safety and feasibility of EUS-CDS using LAMS as the primary drainage strategy in patients with MBO. However, the high incidence of stent dysfunction currently limits the use of EUS-CDS with LAMS solely as a valid alternative to ERCP with SEMS.

References

1. Bang et al. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). Gastrointest Endosc. 2018 Jul;88(1):9-17.
2. Paik et al. EUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2018 Jul;113(7):987-997.
3. van der Gaag et al. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37.
4. Tol et al. Metal or plastic stents for preoperative biliary drainage in resectable pancreatic cancer. Gut. 2016 Dec;65(12):1981-1987.
5. Gorris et al. Does same session EUS-guided tissue acquisition and ERCP increase the risk of pancreatitis in patients with malignant distal biliary obstruction? HPB (Oxford). 2022 Apr;18:S1365-182X(22)00098-3.

Disclosure

Jeska A. Fritzsche, Marc G. Besselink, Olivier R.C. Busch and Freek Daams have no conflicts of interest or financial ties to disclose.
Paul Fockens performed as a consultant for Olympus and Cook Endoscopy.
Johanna W. Wilmink reports research grants from Servier, Celgene, Halozyme, Merck, Roche, Pfizer, Amgen and Novartis, and nonfinancial support from MSD and AstraZeneca.
Rogier P. Voermans reports research grants from Boston Scientific and Prion Medical, performed as a consultant for Boston Scientific, and received speaker’s fee from Mylan and Zambon.
Roy L.J. van Wanrooij performed as a consultant for Boston Scientific. All outside the submitted work.

Introduction

EUS-guided hepaticogastrostomy (EUS-HGS) is a novel technique that allows internal drainage of the biliary system via the stomach. This approach may be of value in patients with duodenal obstruction, surgically altered anatomy, or in hilar strictures with inadequate drainage of the left hepatic duct by other techniques (1, 2). However, this procedure has a high technical complexity and until recently no dedicated stents were available exposing the patient to adverse events such as the risk of biliary leakage and stent migration (3). A partially covered self-expanding metallic stent (pcSEMS) with anti-migration flaps may overcome these risks. So far, the available data on the use of this specific stent is limited, and prospective studies are particularly missing.

Aims & Methods

Aim of this study was to assess the safety and feasibility of EUS-HGS in patients with an inoperable malignant biliary obstruction, with the use of this dedicated stent. This prospective single-center study included patients with inoperable malignant biliary obstruction that underwent an EUS-HGS. Patients were ineligible in case of uncontrolled coagulopathy, tumor infiltration in the gastric wall, intervening blood vessels or extensive amount of ascites. Procedure was performed with a 10cmx10mm pcSEMS (Giobor stent, Taewoong Medical). Primary outcome was safety, defined as rate of procedural related adverse events (AEs) and mortality <30 days. Technical and clinical success rate were evaluated as secondary endpoints, defined as successful deployment of the stent in the intended location and at least 50% decrease of bilirubin <14 days.

Results

Between January 2022 and July 2024, 25 patients (14 female [56%], median age 70 years [IQR 64-76]) were included. Reason to perform EUS-HGS included duodenal obstruction (n=12), altered anatomy (n=6) or failed drainage of the left hepatic duct by ERCP (n=7). In 21/25 patients EUS-HGS was technically successful (84%). In one patient the procedure was aborted due to a self-limiting bleeding after puncture of the bile duct, in one patient due to unsuccessful cannulation of the central bile duct and in two patients the cholangiogram showed previously unidentified intrahepatic strictures that precluded adequate drainage by EUS-HGS. No severe periprocedural AEs occurred. Three patients (14%) were re-admitted with presumed cholangitis <30 days after the procedure; two with undrained right-sided bile ducts for which a percutaneous drain was placed, and one patient due to obstruction of the bile duct branches by the covered part of the stent, for which an endoscopic re-intervention was performed replacing the Giobor stent by a fully covered and uncovered SEMS. Five patients died within 30 days due to fulminant disease progression. None of these patients experienced procedural related AEs. Clinical success was achieved in 18/19 (95%) patients with technical success and follow-up of at least two weeks. Six out of the 18 patients with clinical success developed recurrent biliary obstruction after a mean of 105 days (SD 80). Obstruction was caused by hyperplasia at the uncovered portion of the stent (n=3) and due to sludge obstructing the stent (n=3). Successful re-intervention was performed in all patients.

Conclusion

This prospective study shows that EUS-HGS with a dedicated partially covered stent is feasible and safe. Tissue hyperplasia in the uncovered part of the stent and sludge obstruction may compromise long-term stent patency. Larger, comparative studies addressing stent design and timing of EUS-HGS are eagerly awaited.

References

1. Pawa, S., et al., American Society for Gastrointestinal Endoscopy guideline on the role of therapeutic EUS in the management of biliary tract disorders: summary and recommendations. Gastrointest Endosc, 2024.
2. van der Merwe, S.W., et al., Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy, 2022. 54(2): p. 185-205.
3. Binda, C., et al., Efficacy and safety of endoscopic ultrasound-guided hepaticogastrostomy: a meta-regression analysis. Endoscopy, 2024. 56(9): p. 694-705

Introduction

EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) is an alternative for ERCP in patients with a malignant distal biliary obstruction (MBO).(1,2) The main drawback of EUS-CDS using LAMS is the high rate of stent dysfunction which leads to cholangitis and reinterventions.(3,4) Presumably, the short length and perpendicular angle of the LAMS to the bile duct contribute to the risk of stent dysfunction.(5) Therefore, the aim was to investigate whether placement of a fully covered self-expandable metal stent (FCSEMS) through the LAMS, thereby changing the axis of biliary drainage towards the descending duodenum, will decrease the risk of stent dysfunction while maintaining high technical success and low adverse event rates.

Aims & Methods

We performed a prospective pilot study in patients with proven MBO and a bile duct diameter of at least 12mm, requiring biliary drainage, excluding patients with gastric outlet obstruction. Patients underwent biliary drainage with (as first procedure) EUS-CDS using a 6 or 8 mm LAMS with a 6 cm by 8 or 10 mm FCSEMS placed through the LAMS. Primary outcome was stent dysfunction, defined as recurrent jaundice after initial clinical success, ongoing jaundice in combination with persistent dilatation of the bile ducts, or cholangitis. Secondary outcomes were technical success, clinical success, and adverse events (AEs).

Results

Overall, 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 patients (83%), in the remaining 4 patients a coaxial double pigtail stent was placed. In 2 patients there was persistent cholestasis requiring stent revision (10%), leading to a clinical success rate of 90%. No patients developed stent dysfunction after initial clinical success.

Periprocedural AEs occurred in 3 patients (11%) due to LAMS maldeployment which was solved intraprocedurally in all patients. In 1 patient this led to biliary peritonitis and fluid collections requiring percutaneous drainage, the other 2 patients recovered uneventfully. Two patients experienced cholecystitis within 30 days after the procedure (10%), one patient who also had concomitant renal failure subsequently deceased. The other patient recovered after antibiotics and percutaneous drainage. Two other patients deceased within 30 days which was unrelated to the procedure.

Table. Baseline characteristics in 27 patients undergoing EUS-CDS

Conclusion

This study showed a stent dysfunction rate of 10% following technically successful EUS-CDS with placement of a FCSEMS through the LAMS. Improving the LAMS design may reduce the rate of stent dysfunction by improving the direction of bile flow through the stent towards the descending duodenum.

References

1. Teoh AYB, Napoleon B, Kunda R et al. EUS - guided choledocho-duodenostomy using lumen apposing stent versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction. A multi-center randomized controlled trial. (DRA-MBO trial). Gastroenterology. 2023.
2. Chen YI, Sahai A, Donatelli G et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023.
3. Vanella G, Bronswijk M, Dell'Anna G et al. Classification, risk factors, and management of lumen apposing metal stent dysfunction during follow-up of endoscopic ultrasound-guided choledochoduodenostomy: Multicenter evaluation from the Leuven-Amsterdam-Milan Study Group. Dig Endosc. 2023.
4. Fritzsche JA, Fockens P, Besselink MG et al. Endoscopic ultrasound-guided choledochoduodenostomy using single-step lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-p): a prospective pilot study. Endoscopy. 2023.
5. El Chafic AH, Shah JN, Hamerski C et al. EUS-Guided Choledochoduodenostomy for Distal Malignant Biliary Obstruction Using Electrocautery-Enhanced Lumen-Apposing Metal Stents: First US, Multicenter Experience. Dig Dis Sci. 2019.

Disclosure

Jeska A. Fritzsche, Marc G. Besselink, Olivier R. Busch and Mattheus C.B. Wielenga have no conflicts of interest or financial ties to disclose. Paul Fockens performed as a consultant for Olympus and Cook Endoscopy. Freek Daams reports research grants from Medtronic, and received speaker ‘s fees from Medtronic, and proctoring fees from Intuitive. Johanna W. Wilmink reports research grants from Servier, Merck, Nordic and Astra Zeneca. Rogier P. Voermans reports research grants from Boston Scientific and Prion Medical, performed as a consultant for Boston Scientific, and received speaker’s fees from Mylan and Zambon. Roy L.J. van Wanrooij performed as a consultant for Boston Scientific. All outside the submitted work.

Introduction

Management of acute cholecystitis in high-risk surgical candidates presents a clinical challenge. Percutaneous drainage via a cholecystostomy tube has been the preferred alternative in this cohort, with high rates of complications and low patient acceptability. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen-apposing metal stents (LAMS) has been proposed as an alternative. Although several prospective studies and one randomised control trial have been published, it is not current standard of practice and there remains some concerns regarding its safety and efficacy.

Aims & Methods

This study evaluates the efficacy and safety of EUS-GBD for non-surgical candidates presenting with acute cholecystitis in the largest prospective cohort at a tertiary hospital within Australia and New Zealand. From July 2024, prospectively collected cases who underwent EUS-GBD using LAMS were entered into a secure database at our institution. Patients were followed for up to 180 days after index EUS-GBD procedure. Primary outcomes included technical and clinical success. Secondary outcomes include adverse events (AE), re-intervention rates and mortality.

Results

Twenty four patients (12 females, 12 males; mean age 75.5 years; range: 54–90) were included from July 2024 to April 2025. Patients were comorbid (mean Charlson Comorbidity Index 5.1), frail (mean Clinical Frailty Scale 4), and had high peri-operative risk (mean ASA score 3). EUS-GBD was technically and clinically successful in 100% of cases. Two (8.33%) patients experienced adverse events (stent occlusion requiring reinterventions). One (4.15%) patient developed atrial fibrillation driven by underlying sepsis necessitating admission to the high-dependency unit following EUS-GBD. There was one death occurring 23 days following EUS-GBD, deemed unrelated to the procedure. There were no procedure related mortality during the study period with an average follow up of 155 days.

Conclusion

Our study demonstrates that EUS-GBD is an effective and safe management option for gallbladder drainage in non-surgical candidates with acute cholecystitis. The high technical and clinical success rates, coupled with few procedure-related complications, support its use as the preferred option for drainage in otherwise poor surgical candidates due to significant medical comorbidities. However, larger studies are needed to validate these findings.

Disclosure

Drs Weilert, Chin and Prof. Fockens - consultants for Boston Scientific

Introduction

Endobiliary radiofrequency ablation (eRFA) is expected to prolong stent patency in malignant biliary obstruction. However, data on eRFA combined with uncovered self-expanding metal stents (uSEMS) in perihilar cholangiocarcinoma (pCCA) are scarce.(1,2)

Aims & Methods

Aim of this prospective single-centre pilot study was to evaluate whether eRFA prior to uSEMS placement is feasible in patients with inoperable pCCA. This study included 10 patients with inoperable pCCA undergoing eRFA prior to endoscopic placement of uSEMS. Endobiliary RFA was performed using a temperature controlled RFA electrode at 7 watt, 90 sec, 75°C. All patients were followed up until death or the end of the study (after at least 12 months follow up). Primary endpoints were technical success, clinical success and adverse events (AEs). Secondary endpoints were time to recurrent biliary obstruction, stent patency at 6 months, and overall survival.

Results

Baseline characteristics are presented in the table. All patients underwent previous successful drainage with plastic stents and/or percutaneous in-/external drainage catheters. In 7 patients the procedure was scheduled electively, where in 3 patients there was an increase in cholestasis and/or fever in the days before the intervention.
The procedure was technically and clinically successful in all patients. One patient was admitted due to self-limiting bleeding after the intervention preceded by sphincterotomy. No other procedure related serious AEs occurred <30 days. Seven patients experienced transient abdominal discomfort after the procedure, sufficiently treated with oral analgesics. The median score on a Numeric Rating Scale (NRS) was 2 (IQR 0.25-3.75) after 1 day and the median duration of pain was 1 day (IQR 0-2.5) after the procedure.
During follow-up 7 patients experienced recurrent biliary obstruction caused by tumor ingrowth (n=6) or sludge (n=1) after a median of 6 months (range 1-8). Of the 3 patients with a patent stent at end of follow-up, two patients deceased after 2 and 6 months follow-up, the other patient still had a patent stent at the end of follow-up. Stent patency rate at 6 months follow-up was 67% (6/9). Four patients died after a median of 16 months (range 4-24) since diagnosis, not related to stent dysfunction.

Table. Baseline characteristics of 10 patients with pCCA undergoing eRFA and uSEMS placement

Conclusion

This pilot study confirms the safety and feasibility of eRFA in patients with pCCA. Risk of adverse events seems low and abdominal pain after the procedure mild. Randomised controlled trials are warranted to assess the efficacy of eRFA for pCCA.

References

1. Sofi AA, Khan MA, Das A, Sachdev M, Khuder S, Nawras A, et al. Radiofrequency ablation combined with biliary stent placement versus stent placement alone for malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2018;87(4):944-51.e1.
2. de Jong DM, Fritzsche JA, Audhoe AS, Yi SSL, Bruno MJ, Voermans RP, et al. Comparison of Intraductal RFA Plus Stent versus Stent-Only Treatment for Unresectable Perihilar Cholangiocarcinoma-A Systematic Review and Meta-Analysis. Cancers (Basel). 2022;14(9).

Disclosure

Jeska A. Fritzsche, Mattheus C.B. Wielenga, Otto M. van Delden and Joris I. Erdmann have no conflicts of interest or financial ties to disclose.
Heinz-Josef Klümpen performed in advisory board for Janssen, Astra-Zeneca, and IPSEN. Received Speaker’s fee from CCO and MedTalks. Roy L.J. van Wanrooij performed as a consultant for Boston Scientific. Paul Fockens performed as a consultant for Olympus and Cook Endoscopy.
Cyriel Y. Ponsioen reports research grants from Gilead and Perspectum, performed as a consultant for Pliant, Takeda and Shire, and received speaker’s fees from Tillotts.
Rogier P. Voermans reports research grants from Boston Scientific and Prion Medical, performed as a consultant for Boston Scientific, and received speaker’s fee from Mylan and Zambon.
All outside the submitted work.