Introduction

Endoluminal radiofrequency ablation (RFA) is a palliative treatment option for patients suffering from malignant biliary obstruction.

Aims & Methods

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 from inception until November 2023 for patients who underwent stenting with or without RFA for extra-hepatic malignant biliary obstruction. A random effects model was employed for analysis and results conveyed using risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI).

Results

Nine RCTs involving 750 subjects (n=374 RFA plus stent vs n=376 stent only) diagnosed with malignant biliary obstruction were included. Overall, there was no difference in stent patency between both groups (MD = 26 days [95% CI -2.63 – 54.85]; I²=53%, P=0.07), however, RFA showed improved overall survival (MD = 1.64 months [95% CI 0.21 – 3.07]; I²=100%, P=0.02). Subgroup analysis showed that patients with cholangiocarcinoma experienced an overall survival benefit with RFA (MD = 4.86 months [95% CI 4.61 – 5.07]; I²=0%, P<0.001), however, stent patency was unaffected (P=0.08). Subgroup analysis comparing plastic versus uncovered metal stents showed no difference in stent patency (P=0.63), however, plastic stents were associated with improved survival (MD = 2.05 months [95% CI 0.60 – 3.50]; I²=91%, P=0.002). An increased incidence of cholecystitis was noted with RFA versus stenting only (5% vs 0.2%, respectively).

Conclusion

Combining endoluminal RFA and stenting may improve overall survival in patients with malignant biliary obstruction. RFA did not impact stent patency significantly.

Introduction

Malignant biliary obstruction (MBO) encompasses a variety of malignancies arising from the pancreaticobiliary system. The relatively common occurrence of duodenobiliary reflux (DBR) in patients with transpapillary stent placement for palliative management raises the importance of the development of alternative methods to prevent adverse outcomes.

Aims & Methods

We aimed to compare supra-papillary to trans-papillary stenting in patients with MBO for stent dysfunction and adverse events. PubMed, Embase, and Cochrane were systematically searched for randomized controlled trials (RCTs). The primary outcome was stent occlusion. Secondary outcomes included stent migration, occurrence of cholangitis or pancreatitis, cumulative duration of stent patency in days, and patient survival in days. Statistical analyses were conducted using R (version 4.3.1) and a random-effects model was employed.

Results

We found 3 RCTs with 161 patients (80 in the supra-papilla stent group vs. 81 in the trans-papilla group). Supra-papillary stent placement was associated with significantly lower rates of stent occlusion (OR 0.42; 95% CI 0.20 to 0.87; p = 0.019), and longer cumulative duration of stent patency (MD 77.59; 95% CI 23.84 to 131.34; p < 0.01). The Trial Sequential Analysis for this outcome showed that this study has surpassed the required information size (n = 158) to ascertain the statistical difference for this outcome. The analyses of stent migration (p = 0.471) occurrence of cholangitis (p = 0.525), and patient survival (p = 0.05) revealed no significant difference between both groups.

Conclusion

We found a significant improvement in stent occlusion rates and cumulative duration of stent patency favoring the supra-papilla group, with no difference for stent migration, occurrence of cholangitis, and patient survival for this comparison.

Introduction

The management of malignant hilar biliary obstruction can be done by endoscopic biliary stenting, which is a well-established palliative treatment, improving the quality of life by relieving symptoms.

Aims & Methods

This systematic review and meta-analysis aimed to compare the use of stents placed above and across the sphincter of Oddi in patients with malignant hilar biliary obstruction. We performed a systematic search of the PubMed, Embase, and Cochrane Library databases in April 2025. Article screening was conducted independently by two authors using Rayyan software. Inclusion criteria were randomized controlled trials (RCTs) comparing stent placement above and across the sphincter of Oddi for malignant hilar biliary obstruction, evaluating at least one of the outcomes of interest. The outcomes were stent migration, stent patency, cholangitis, stent occlusion, and successful placement of the stent. RStudio software was used for statistical analysis, applying a random-effects model to calculate the risk ratio (RR) in binary outcomes and mean differences (MD) in continuous outcomes.

Results

We included three RCTs comprising 161 patients. There was no significant difference between the transpapillary and suprapapillary stents regarding the rates of stent migration (RR 2.03; 95% CI 0.41–10.16; p=0.39; I²=55%), cholangitis (RR 0.65; 95% CI 0.08–5.07; p=0.68; I²=0%), technical success (RR 0.99; 95% CI 0.95–1.04; p=0.80; I²=0%), and stent occlusion (MD 89.20; 95% CI 16.30–162.10; p=0.02; I²=78%). However, the mean number of patent stents was significantly lower in the suprapapillary stent group.

Conclusion

The two types of stent seem similar in terms of technique, efficacy, and safety, although the suprapapillary stent seems superior in terms of stent patency.

References

Ko SW, Joo HD, Song TJ, Kim S, Choi SJ, Oh CH, Oh D, Park JS, Yoon SB, Yoon JH, Seo DW, Lee SK. Impact of the suprapapillary method on patency in distal malignant biliary obstruction: a multicenter randomized controlled trial. Gastrointest Endosc. 2024 Oct;100(4):679-687.e1. doi: 10.1016/j.gie.2024.03.024. Epub 2024 Mar 21. PMID: 38521477.
Kurita A, Uza N, Asada M, Yoshimura K, Takemura T, Yazumi S, Kodama Y, Seno H. Stent placement above the sphincter of Oddi is a useful option for patients with inoperable malignant hilar biliary obstruction. Surg Endosc. 2022 May;36(5):2869-2878. doi: 10.1007/s00464-021-08576-x. Epub 2021 Jun 2. PMID: 34076770.
Finn Møller Pedersen, MD, Annmarie Touborg Lassen, Ove B. Schaffalitzky de Muckadell. Finn Møller Pedersen, MD, Annmarie Touborg Lassen, Ove B. Schaffalitzky de Muckadell. Gastroint Endosc. 1998;48(6):574-579.

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

Distal malignant biliary obstruction (dMBO) presents a significant clinical challenge, necessitating effective drainage strategies to improve patient outcomes. Various drainage procedures have been utilized, encompassing percutaneous transhepatic biliary drainage (PTBD), endoscopic retrograde cholangiopancreatography (ERCP), or Endoscopic ultrasound-guided biliary drainage (EUS-BD) including EUS choledochoduodenostomy (EUS-CDS). However, the first-line optimal drainage approach remains debated. This network meta-analysis aims to compare the efficacy and safety of different drainage techniques for distal malignant biliary obstruction.

Aims & Methods

We conducted a systematic literature search of randomized control trials (RCTs) comparing different drainage methods as first-line treatment for distal malignant biliary obstruction. MEDLINE database was searched for relevant studies. Studies reporting outcomes such as technical success, clinical success, adverse events, and stent patency were included. Data were extracted, and a network meta-analysis was performed to compare the efficacy and safety of PTBD, ERCP and EUS-BD.

Results

Review of 649 studies yielded 7 RCTs meeting inclusion criteria for quantitative synthesis. These studies were published between 1987 and 2023, with 3 conducted in single centers and 4 at multiple centers, spanning all continents worldwide. They collectively involved 653 patients with distal malignant biliary obstruction. In terms of technical success, EUS-CDS demonstrates a significant superiority over ERCP (risk ratio [RR] 1.17, 95% CI 1.01–1.35), while no significant differences were observed in other comparisons. Furthermore, for clinical success, EUS-CDS outperforms alternative interventions (RR 1.12, 95% 1.02-1.24). Both in terms of technical and clinical success, EUS-CDS ranked the highest (surface under the cumulative ranking [SUCRA] score, respectively 0.90 and 0.86). Consequently, EUS-CDS emerges as the premier treatment modality. Regarding adverse events, PTBD exhibits a pronounced inferiority compared to all other interventions (RR 2.74, 95% CI 1.25–6.02), whereas no statistically significant distinctions were noted among the remaining treatments.

Conclusion

In conclusion, our network meta-analysis suggests that EUS-CDS emerges as the most effective first-line intervention for distal malignant biliary obstruction, demonstrating superior technical and clinical success rates compared to ERCP. Furthermore, PTBD appears to carry a higher risk of adverse events compared to alternative treatments. These results underscore the importance of considering EUS-CDS as the preferred initial drainage approach in clinical practice, with potential implications for improving patient outcomes in this challenging condition.

Introduction

EUS-guided choledochoduodenostomy using a lumen-apposing metal stent (EUS-CDSL) has been shown in randomized controlled trials (RCT) to be effective compared to endoscopic retrograde cholangiopancreatography (ERCP) in patients with advanced malignant distal biliary obstruction (MDBO). We aimed to further ascertain the safety of EUS-CDSL, which has been limited by inadequate trial sample sizes.

Aims & Methods

We undertook aggregate and individual patient data (IPD) meta-analyses following the PRISMA-IPD statement. A literature search was performed from January 2013 to November 2024 using OVID MEDLINE, EMBASE, Cochrane Library, and ISI Web of Science. Additional searches were performed for abstracts and the grey literature. RCTs comparing EUS-CDSL to ERCP were included. The primary outcome was the rate of procedure-related 14-day severe or fatal adverse events (AE). Secondary outcomes included technical success, 30-day AE, clinical success, stent dysfunction, and procedure time.

Results

A total of 2679 citations were screened with three RCTs included (519 patients). There was no difference in severe or fatal AEs between EUS-CDSL and ERCP (OR 0.64, 95% CI 0.22- 1.83 for IPD data and RR 0.76, 95% CI 0.22, 1.77 for aggregate data). Technical success was greater for EUS-CDSL (OR 4.22, 95% CI 2.35,7.61 and RR 1.14, 95% CI 1.04, 1.25) with shorter procedural time (mean difference -10.50 minutes (95% CI -15.28, -5.73). No significant differences were noted in 30-day AEs, clinical success, and stent dysfunction.

Conclusion

Our aggregate and IPD meta-analyses demonstrate the safety of EUS-CDSL as a first-line alternative to ERCP in advanced MDBO. In addition, EUS-CDSL is technically superior in terms of success rate and procedure time.