Introduction

Endo-biliary radiofrequency ablation (RFA) is a novel minimally invasive intervention to treat stent occlusion in malignant biliary strictures1. Advances in oncological therapies have improved survival and tumour ingrowth into uncovered self-expanding metal stents (UcSEMS) is common and strategies to manage this are limited2. We aimed to determine the clinical outcomes of endo-biliary RFA using ELRATM probe (Taewoong) in patients with UcSEMS occlusion.

Aims & Methods

Retrospective data was collected from February 2020 to March 2023 at St Thomas’ Hospital.

Results

28 endo-biliary RFA’s were performed in 12 patients for occluded UcSEMS over this period, delivered by 3 operators. Demographics are shown in table 1. Excluding two recent cases, 60% required multiple RFA interventions. The median number of RFA’s was 2, with one patient requiring 9 sessions. One patient was excluded as there was significant parenchymal disease in addition to UcSEMS occlusion and despite RFA, there was progression in liver metastasis. For patients with bilirubin monitoring post RFA, 11 (100%) procedures resulted in a reduction in bilirubin between 1-4 weeks. The average reduction in bilirubin was 61.4% (6/11 patients) at week 1 and 77.4% (9/11 patients) at week 2-4. Excluding 2 recent cases, survival was 90 % at 30 days post procedure, and 70% at 90 days. Survival was 100% at 90 days for cholangiocarcinoma. The patient requiring 9 sessions (not on chemotherapy), survived for 18 months with significantly improved quality of life. There were no recorded complications. Technical difficulties were encountered in 2 cases due to impedance in bilobar stents with a Y configuration due to contact of the probe with metal at the hilum.
Table 1: Demographics
M:F 7:5
Mean age 71
Performance status 0-2
Malignancy Cholangiocarcinoma=5, Pancreatic cancer=4, gall bladder=1, Hepatocellular carcinoma=1,metastatic breast cancer=1

Conclusion

Endo-biliary RFA had good technical and clinical success with measurable reduction in bilirubin in patients with UcSEMS occlusion without any complications in our cohort. It is difficult to say if survival is purely due to biliary drainage or if there is an anti-tumour effect with RFA, especially given the 100% survival at 3 months in patients with cholangiocarcinoma. Additional data from randomised controlled trials is required to assess the role of RFA in malignant strictures.

References

Management of malignant biliary obstruction. Gut 64, A216–A217 (2015).
2. Steel, A. W. et al. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. (2011) doi:10.1016/j.gie.2010.09.031.

Disclosure

Nothing to disclose

Introduction

Malignant biliary obstruction/MBO/is generally managed by biliary stenting however major following problem is stent patency. Recent studies show the advantages of endoscopic retrograde cholangiopancreatography-guided intraductal radiofrequency ablation/ ERCP ID-RFA/ as adjunctive therapeutic modality.

Aims & Methods

Aims: To evaluate the efficacy and safety of ID-RFA in terms of stent patency,symptom–free survival and adverse events/AE/.Primary endpoints–evaluating the period of stent patency and survival;secondary endpoints-assessing AE.
Methods: We performed retrospective analysis of a prospective database including all consecutive patients who underwent ID-RFA for the period July 2021 – December 2022.17 procedures in 16 patients who were unresectable or poor surgical candidates were performed followed by stenting in the study period.

Results

Endobiliary RFA/EB-RFA /catheter (ELRA, STARmed, Taewoong Medical) and RF generator system (VIVA combo, STARmed) were used in 15 of the procedures. In two cases ID-RFA was performed with Habib EndoHPB catheter/Boston Scientific.After passing a guidewire the catheter was positioned at the targeted lesion, followed by 120 s of ablation (target temperature 80°C, 7–10 W,temperature control mode)–in two to three sessions,unilaterally or bilaterally depending on the type and lenght of the stenosis verified by the proceding cholangiogram. The mean period of stent patency defined as time between the date of the procedure and the last follow up of the patient without signs of stent occlusion was 144,36 ± 89.3 days. In this period all of the patients were symptom–free with good quality of life and without any signs of cholangitis.The indications were:10 patients with CCA,two patients/n=2-12.5%/ with intraductal extension of papillary adenoma-both poor surgical candidates -one with HGD;one with HGD with intramucosal carcinoma who underwent endoscopic snare papillectomy /ESP/ followed by endoscopic ID-RFA and placement of stents,2 patients with gallbladder cancer,2 patients with bile duct occlusion due to metastasis.In 9 of the patients with CCA /90% of patients with CCA ;56,25 % of the total number/chemotherapy with Cisplatina/Gemcitabine followed with no interruption of the courses during the period of treatment; one refused chemotherapy.In three of the patients/18.75%/ we performed ID RFA in order to prolong stent patency in occluded by tumor ingrowth metal stents.The rate of the AE was 18.75%/n=3/ - 1 patient with self-limited bleeding;1 patient with postprocedural cholangitis and 1 patient with liver abcess – managed percutaneously.There were no deaths or ICU admissions. We experienced two stent occlusions – in one in patient with papillary adenoma with HGD–on day 169– managed with second session of ID- RFA followed by metal stent placement - asymptomatic up to the last follow up,the second with tumor ingrowth from endobiliary metastasis in previously placed metal stent -the patency after RFA was 116 days – managed with metal stent in stent placement

Conclusion

ID-RFA is a promising new tool which provides improved outcomes in patients with MBO both in stent patency and symptom free survival.It has many advantages – easy delivery of controlled temperature application and good safety profile.Therefore ID-RFA can be proposed as adjunctive treatment in patients with MBO although more randomized studies are needed.

Introduction

Malignant biliary obstruction (MBO) poses significant therapeutic challenges, particularly in patients ineligible for surgery [1]. Endobiliary radiofrequency ablation (RFA) has emerged as a promising palliative therapy, aiming to enhance stent patency and patient survival [2]. However, conventional catheter-based electrodes may encounter limitations, such as incomplete tumor ablation due to insufficient contact with the inner wall of the bile duct [3].

Aims & Methods

This study aimed to validate the feasibility of the stent-based electrode (SBE)-RFA system with polarity-switching and evaluate its efficacy in achieving circumferential ablation lesions in the porcine bile duct. A bipolar SBE consisting of two electrodes fabricated by braiding nitinol wires was designed and characterized along with a custom RFA generator capable of a polarity-switching system. Ex vivo studies using porcine livers were performed to evaluate the ablation ranges under various ablation protocols combining output power and ablation times. Subsequently, an animal study involving nine male Yorkshire pigs was performed, employing selected protocols based on ex vivo findings. The RFA procedure was conducted in the porcine common bile duct (CBD) under fluoroscopic guidance, with pre- and post-procedural assessments including cholangiography, endoscopic examination, and histological analysis.

Results

The SBE with custom RFA generator was demonstrated that temperature feedback and power output were accurate and showed high reproducibility. The SBE was successfully positioned at the correct location during the procedure through fluoroscopy and ultrasound guidance, and complete contact with the bile duct wall was confirmed. The ablation ranges of the porcine liver increased with output power and time, showing proportional growth and an even ablation area between electrodes. Endobiliary RFA in the porcine CBD was technically successful without ductal perforation, resulting in luminal narrowing proportional to output power and ablation time. Mucosal damage, including hemorrhagic erosion and erythema, was observed, intensifying with higher RFA-related parameters. Histological examination revealed increased inflammatory cell infiltration, hemorrhage, and cellular necrosis in correlation with output power and time. Additionally, the ablation area in the porcine CBD was formed in an even circumferential shape, and this also proportionally increased as output power and time increased.

Conclusion

In conclusion, this study demonstrates the technical feasibility and efficacy of endobiliary RFA utilizing a novel bipolar SBE-RFA system with polarity-switching system. This system exhibited controlled and predictable ablation ranges in the porcine CBD, offering potential as a palliative therapeutic option for unresectable MBO. Although further studies in obstructive animal models and long-term efficacy assessments are necessary, these findings suggest that promising prospects form the clinical application of the bipolar SBE-RFA system in managing MBO.

References

[1] Sumiyoshi T, Shima Y, Okabayashi T, Negoro Y, Shimada Y, Iwata J, et al. Chemoradiotherapy for Initially Unresectable Locally Advanced Cholangiocarcinoma. World J Surg. 2018;42(9):2910-8.
[2] Oh D, Chong J, Song TJ, Park DH, Lee SS, Seo DW, et al. The usefulness of endobiliary radiofrequency ablation before metal stent placement in unresectable malignant hilar obstruction. J Gastroenterol Hepatol. 2022;37(11):2083-90.
[3] Inoue T, Yoneda M. Updated evidence on the clinical impact of endoscopic radiofrequency ablation in the treatment of malignant biliary obstruction. Dig Endosc. 2022;34(2):345-58.

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.

Clinical Case Summary

Placement of self-expandable metal stents (SEMS) is a standard treatment in the palliation of unresectable malignant biliary obstruction, whereas multidisciplinary oncology treatment prolongs patient survival. Consequently, the likelihood of stent-related complications has increased. Distal migration is a rare cause of stent dysfunction and SEMSs are relatively hard to extract after insertion. We present the management of a patient with dislocated SEMS using argon plasma coagulation (APC).
An 88-year-old man with unresectable ampullary cancer and consequential biliary stricture underwent a transpapillary placement of a 6-cm-long, 10-mm diameter uncovered SEMS (uSEMS).
Twelve months later, he presented to our department with vomiting. Given the high index of suspicion for stent dysfunction, a duodenoscopy was performed. Direct endoscopic visualization showed a distal 3-cm-long migration of the uSEMS. The distal end of uSEMS was firmly impacted in the contralateral duodenal wall resulting in reactive tissue ingrowth narrowing both the stent and the duodenal lumen. Significant malignant duodenal obstruction was detected below the dislocated uSEMS.
Subsequently, it was attempted to trim the distal 2 cm of the stent using an axial APC probe (power setting 80W, gas flow 0,8 L/min). The trimmed stent was removed with biopsy forceps. The procedure lasted 20 min, without immediate complications and the patient was discharged within 2 days.
One month after the procedure, the patient was readmitted with recurrent vomiting. Endoscopy revealed duodenal stricture below the papilla of Vater, due to malignant disease progression. Therefore, an 8-cm-long, 20-mm diameter duodenal SEMS placement was performed under simultaneous endoscopic and fluoroscopic control and symptoms were soon relieved.
This case highlights endoscopic APC stent trimming as an efficient procedure, which allows easy, reproducible and well−tolerated management of migrated uSEMS-related complications.

References

Fig. 1. Dislocated uSEMS and reactive tumor ingrowth
Fig. 2. (a) Trimming of the distal end using APC (b) the remaining stent in situ

1. Yokode, M., Matsumori, T., Uza, N., Kuwada, T., Shiokawa, M., Maruno, T., & Seno, H. (2022). Usefulness of a circumferential argon plasma coagulation probe in trimming a dislocated distal biliary metal stent. Endoscopy, 54, E802–E803. https://doi.org/10.1055/a-1816-7903
2. Azevedo, R., Libânio, D., Bastos, P., Dinis Ribeiro, M., & Brandão, C. (2019). Going through the Mesh: Argon Plasma Trimming of a Metal Biliary Stent. GE Portuguese Journal of Gastroenterology, 26(4), 295–297. https://doi.org/10.1159/000493352
3. Ishii, K., Itoi, T., Sofuni, A., Itokawa, F., Tsuchiya, T., Kurihara, T., Tsuji, S., Ikeuchi, N., Umeda, J., Moriyasu, F., & Tsuchida, A. (2011). Endoscopic removal and trimming of distal self-expandable metallic biliary stents. World Journal of Gastroenterology, 17(21), 2652–2657. https://doi.org/10.3748/WJG.V17.I21.2652
McDonald, N. M., & Amateau, S. K. (2022). Jailbreaking a metal biliary stent through a duodenal stent. VideoGIE, 7(6), 226–228. https://doi.org/10.1016/j.vgie.2022.02.002
4. Vanbiervliet, G., Piche, T., Caroli-Bosc, F. X., Dumas, R., Peten, E. P., Huet, P. M., Tran, A., & Demarquay, J. F. (2005). Endoscopic argon plasma trimming of biliary and gastrointestinal metallic stents. Endoscopy, 37(5), 434–438. https://doi.org/10.1055/S-2005-860989

Introduction

With accumulating evidence on endoscopic ultrasonography-guided hepaticogastrostomy (EUS‑HGS) as a salvage treatment for malignant biliary obstruction (MBO), EUS-HGS has now recognized as one of the primary options even in patients with possible ERCP. However, recurrent biliary obstruction (RBO) occasionally occurs after EUS-HGS and it might impose a heavy burden on patients.

Aims & Methods

This study aimed to investigate the safety and effectiveness of reintervention for RBO after EUS-HGS.
Between August 2011 and February 2023, 177 patients with MBO underwent EUS-HGS using self-expandable metal stent (SEMS), and among them a total of 45 patients who required reintervention for RBO after EUS-HGS were enrolled in this study. Technical success (defined as successful reintervention through the HGS stent), clinical success (defined as successful management of cholangitis and/or a 50% decrease or normalization of the bilirubin level within 14 days after any reintervention), adverse events (AEs), time to RBO (TRBO) and overall survival (OS) were investigated. Potential factors associated with technical success were also explored.

Results

MBO was located at distal in 26 (57.8%) and at proximal in 19 (42.2%), with major underlying disease of biliary tract cancer (n = 21, 46.7%) and pancreatic cancer (n = 18, 40.0%). Five patients with proximal MBO underwent EUS-HGS combined with bridging stenting across the hepatic hilum, while all of the remaining had EUS-HGS alone. Median time to reintervention after EUS-HGS was 80 days (95% CI, 62-131 days) and the major causes of reintervention were hyperplasia at uncover portion of the EUS-HGS stent (n = 24, 53.3%) followed by food impaction or sludge formation (n = 8, 17.8%), stent migration (n = 5, 11.1%) and additional biliary obstruction (n = 4, 8.9%). Technical success was achieved in 39 (88.9%). In 6 cases with technical failure, salvage procedures including ERCP (n = 3), PTBD (n = 2) and additional HGS (n = 1) were performed, which eventually resulted in clinical success in 43 patients (95.5%). Although a mild transit fever was developed in one patient, no severe AEs or procedure-related deaths were observed. Median TRBO and OS after reintervention were 168 days and 161 days, respectively. Notably, patients with distal MBO had a longer TRBO while a shorter OS as compared to those with proximal MBO (median TRBO of 168 days vs. 118 days, p = 0.041 and median OS of 113 days vs. 345 days, p = 0.025). Proximal MBO was associated with technical failure of reintervention in multivariable analysis (odds ratio of 7.26, 95% confidence interval, 0.18-0.98, p = 0.046).

Conclusion

Reintervention for RBO after EUS‑HGS was technically feasible and clinically effective, without any severe AEs, especially in patients with distal MBO.

Introduction

Hilar malignant biliary stricture, caused by malignant tumors, often leads to late diagnosis due to subtle initial symptoms, resulting in poor outcomes. Effective endoscopic interventions significantly improve quality of life and survival, yet often lead to post-operative complications like cholangitis.

Aims & Methods

This study aims to assess the effectiveness and safety of utilizing sequential nasobiliary tube cutting as an alternative to stent placement post-nasobiliary drainage in patients, specifically in mitigating post-operative cholangitis. Additionally, to identify risk factors associated with the development of post-operative cholangitis.
Patients diagnosed at Hangzhou First People's Hospital from January 2015 to January 2023 were divided into nasobiliary tube cutting group and conventional stent group. The former underwent nasobiliary drainage followed by tube cutting when stable, transitioning from external to internal drainage, while the latter received standard stent placement. Statistical analyses compared postoperative cholangitis incidence, drainage success, interventions, complications, and hospital stay, further examining risk factors for postoperative cholangitis.

Results

1. This study encompassed a total of 208 patients, with 103 in the nasobiliary tube cutting group and 105 in the conventional stent group. Postoperative cholangitis occurred in 40 patients, with 12 cases (11.7%) in the nasobiliary tube cutting group and 28 cases (26.7%) in the conventional stent group, showing a statistically significant difference between the two groups (P=0.006). The number of patients whose total bilirubin levels decreased by more than 50% within 7 days postoperatively was 50 (48.5%) in the nasobiliary tube cutting group and 29 (27.6%) in the conventional stent group, a statistically significant difference favoring the nasobiliary tube cutting group (P=0.002). There was no statistically significant difference in the overall drainage success rate between the two groups (P=0.207). Besides postoperative cholangitis, there were no statistically significant differences in other postoperative complications between the two groups (P>0.05). The postoperative hospital stay was longer for patients in the nasobiliary tube cutting group than those in the conventional stent group, with median durations of 10.0 (7.0, 14.0) days versus 7.0 (5.5, 12.5) days, respectively, a difference that was statistically significant (P=0.024).
2. Based on whether postoperative cholangitis occurred, the patients were further categorized into a postoperative cholangitis group (n=40) and a non-postoperative cholangitis group (n=168). Univariate analysis revealed significant differences between the postoperative cholangitis group and the non-postoperative cholangitis group in terms of gender (male), Bismuth-Corlette classification (Type IV), number of ERCP procedures (≥2 times), and re-intervention (P<0.05). Multivariate logistic regression analysis identified Bismuth-Corlette classification (Type IV) (OR=3.207, 95%CI: 1.253-8.210, P=0.015) as an independent risk factor for developing postoperative cholangitis.

Conclusion

For patients with hilar malignant biliary stricture, sequential cutting of nasobiliary tubes as an alternative to stent placement after nasobiliary drainage can reduce the incidence of postoperative cholangitis and achieve early successful drainage, but it results in a prolonged postoperative hospital stay. Bismuth-Corlette classification (Type IV) is an independent risk factor for the development of postoperative cholangitis.

References

[1] VALLE J W, KELLEY R K, NERVI B, et al. Biliary tract cancer [J]. Lancet (London, England), 2021, 397(10272): 428-444.
[2] KHALAF N, EL-SERAG H B, ABRAMS H R, et al. Burden of Pancreatic Cancer: From Epidemiology to Practice [J]. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2021, 19(5): 876-884.
[3] ELMUNZER B J, MARANKI J L, GóMEZ V, et al. ACG Clinical Guideline: Diagnosis and Management of Biliary Strictures [J]. Am J Gastroenterol, 2023, 118(3): 405-426.
[4] PIMPINELLI M, MAKAR M, KAHALEH M. Endoscopic management of benign and malignant hilar stricture [J]. Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society, 2023, 35(4): 443-452.
[5] BANG J Y, HAWES R, VARADARAJULU S. Endoscopic biliary drainage for malignant distal biliary obstruction: Which is better - endoscopic retrograde cholangiopancreatography or endoscopic ultrasound? [J]. Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society, 2022, 34(2): 317-324.
[6] IRISAWA A, MIYOSHI H, ITOI T, et al. Recent innovations in therapeutic endoscopy for pancreatobiliary diseases [J]. Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society, 2020, 32(3): 309-315.

Disclosure

The authors declare that there are no conflicts of interest.