Introduction

Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed with reusable duodenoscopes and, infections due to colonization of the endoscope are an increasing problem. The single-use EXALT Model D duodenoscope (Boston Scientific Corporation, USA) has been recently developed to avoid the risk of cross-transmission and the need for endoscope reprocessing.
The aim of this study is to report the experience of a high-volume endoscopy center in the use of this new device.

Aims & Methods

This is a retrospective observational study performed at a single high-volume endoscopy center. All consecutive patients undergoing ERCP performed with EXALT single-use duodenoscope by expert endoscopists from April 2010 to November 2022 were reviewed from a prospectively maintained ERCP database. Demographic and technical data, indications, AEs, and ERCP success rate were recorded. Statistical analysis was performed with SPSS 20 software. Descriptive data are reported as mean/median ± standard deviation/range, or percentage.

Results

Nineteen patients were included (4 children with an age of 7, 7, 11, 17). Patients’ characteristics are summarized in Table 1. Post-Liver transplantation immunodeficiency was the most common indication for the use of disposable duodenoscope (9, 47.3%), followed by SARS-CoV2 infection (6, 31.5%) (cases performed during the weekend with difficult access to reprocessing) and immunodeficiency (4, 21%). Twelve native papillae were recorded (63.1%) undergoing biliary sphincterotomy in 10 cases (52.6%) and pancreatic sphincterotomy in 1 case (5.2%). In 1 case (5.2%) precut was needed after cross-over to reusable duodenoscope. Seven cases of non-native papilla were recorded (36.8%). ERCP was completed with the single use duodenoscope in 17 cases (87.4%). In two cases a cross-over to standard duodenoscope was needed for technical failure of the insufflation valve and for the impossibility to achieve a long-route position in the second case, to approach a papilla at the inferior duodenal genu. One case of delayed bleeding (5.2%) managed endoscopically, and 1 case of post-ERCP pancreatitis (5.2%) managed conservatively, were recorded.

Table 1: Patients characteristics (n: number, LT: liver transplantation, AEs: adverse events).

Conclusion

EXALT single use duodenoscope resulted efficient and safe in the management of bilio-pancreatic diseases, also in children. However, the scope leads to some difficulties when used in non-standard anatomical scenarios. The real advantages of disposable duodenoscope and the environmental/cost impact are still controversial issues, and more studies are need for conclusive data.

Introduction

Post-ERCP pancreatitis (PEP) is the most frequent adverse event (AE) following ERCP with a 3.5-9.7% overall incidence across studies. ERCP is performed also to treat post-liver transplantation (LT) biliary complications. The occurrence of PEP in LT patients is not well studied, however in some series a slight increase in PEP incidence has been described.
The aim of this study is to perform a case-control study to evaluate the risk for PEP in post-LT patients.

Aims & Methods

This is a case-control retrospective study performed at a single high-volume endoscopy center. All consecutive patients undergoing ERCP for the first time (native papilla) for post-LT biliary complications from January 2015 to September 2022, were reviewed from a prospectively maintained ERCP database. The control group consisted of patients with native papilla undergoing ERCP for indications different than post-LT biliary complications at the same unit from January 2019 to December 2019. Demographic data, technical data, and post-ERCP AEs were recorded. Rectal indomethacin was administrated in all cases as PEP prophylaxis. General anesthesia or deep sedation was used in all cases. Statistical analysis was performed with SPSS 20 software. Descriptive data are reported as mean/median ± standard deviation/range, or percentage. Categorical data were compared using the χ₂ test. P values <0.05 were considered statistically significant.

Results

One hundred and six post-LT patients were included in the “case” group and 452 in the “control” group. Patients’ characteristics are summarized in Table 1. PEP prevalence was significantly higher in the case group (8/106, 7.5%) compared with the control group (15/452, 3.5%) (OR: 2.37, 95% CI: 0.98-5.75, P= 0.048). Double guide-wire cannulation prevalence (considered a criterion of difficult cannulation) was significantly higher in the case group (21/106, 19.8%) compared with the control group (54/442, 12.2%) (OR: 1.78, 95% CI: 1.02-3.10, P= 0.041). PEP prevalence resulted still higher in LT patients (OR: 4.19, 95% CI: 1.01-6.06, P= 0.04) after exclusion from the control group of pancreatic cancer patients (n=104), considered at lower risk for PEP assuming pancreatic duct obstruction as a protective factor.

Table 1: Patients characteristics (n: number, LT: liver transplantation, AEs: adverse events, PEP: post-ERCP pancreatitis).

Conclusion

LT patients are at higher risk of PEP when compared with patients undergoing ERCP for other indication. Biliary cannulation seems to be more difficult in LT patients and this could explain the higher risk of PEP. The main limitations of this study are the retrospective design and the presence of a historic cohort group as controls. Prospective studies are needed to confirm these data.

References

[1] Kochar B, Akshintala VS, Afghani E, et al. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc 2015; 81: 143-149.e9.
[2] Moy BT, Birk JW. A review on the management of biliary complications after orthotopic liver transplantation. Journal of clinical and translational hepatology. 2019 Mar 28;7(1):61.
[3] Kochhar G, Parungao JM, Hanouneh IA, Parsi MA. Biliary complications following liver transplantation. World J Gastroenterol. Published online 2013. doi:10.3748/wjg.v19.i19.284.

Introduction

Biliary adverse events manifest in approximately 25% of liver transplant recipients. Among these, anastomotic biliary strictures (ABS) are the most prevalent, occurring in approximately 6%‐12% of cases and can be successfully managed endoscopically.

Aims & Methods

Our study aims to present the evolution of method and long-term results of placing multiple plastic stents to treat ABS after orthotopic liver transplantation (OLT). All consecutive patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for liver transplantation-related biliary complications at our Endoscopy Unit between July 1994 and September 2022 were retrospectively identified. The analysis focused only on the patients diagnosed with ABS undergoing dilatation by a progressively increasing number of plastic stents. Follow-up after stent removal was obtained by office visit, telephone contact with the patient or referring physician and extended to this year or until patient succumbed.

Results

Two hundred and ninety-five patients referred by 4 Liver Transplant Units underwent ERCP in need of endoscopic treatment for biliary complications after liver transplantation. However only 151 represented our intention-to-treat group with ABS. Out of these, 21 patients were excluded because of split liver transplantation, the use of metallic stents or incomplete endoscopic treatment. The mean age of the remaining 130 patients was 56 ± 9 years old and included 107 males and 23 females. We divided these patients in 2 groups according to similar timeframes, 28 ABS patients being treated before 2008 and 102 patients after 2008. In the first group the median number of stents was 4 (range 2-7), with a median of 3 ERCPs (range 2-5) per patient. Patients treated after 2008 received a median number of 6 stents (range 3-9) (p = .000, Mann-Whitney U), with a median of 4 ERCPs (range 3-7) (p = .002, Mann-Whitney U). The mean treatment duration was 15.3 ± 16.7 months in the first group and 14 ± 10 months in the second. Stricture recurrence was noted in 14.2% of patients treated before 2008 versus 4.9% after 2008. Nevertheless, the follow-up period was 10.6 ± 7.5 years for the first group and 4.7 ± 4 years in the second group.

Conclusion

The endoscopic treatment with multiple plastic stents proved to be effective for the majority of patients with ABS after OLT. In the last decade, the endoscopists shifted towards a more aggressive treatment strategy, with an increased number of stents and a reduced period between stent replacement procedures. This intensive approach seems also to underline a lower stricture recurrence rate however a longer follow-up period needs to be considered for the patients treated after 2008.

Introduction

Infection related morbidity and mortality is still a major hazard associated with the standard re-usable duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP). The single use duodenoscope (SUD) has been developed as a potential disposable instrument for preventing cross-transmission of infections via contaminated devices in high-risk patients. However, data for the use of SUD in real-world practice is very scarce.

Aims & Methods

In this study we aimed to assess our single centre experience with SUDs in patients underwent ERCPs, in terms of performance and safety. We included all the patients who underwent ERCP with the use SUD (Boston Scientific designed EXALT Model D) between October 2020 and February 2023 at Cambridge University Hospitals. Based on the retrospective review of procedure notes, outcomes were analysed with regards to procedure indication, success rate for the intended clinical indication, interventions performed, and adverse events. The SUD was used when prespecified institutional criteria (immunocompromised patient, multi drug resistant infection or failed procedure with standard re-usable duodenoscopes) were met or when there was no reusable duodenoscopes available at the time of procedure.

Results

The SUD was used in total of 34 patients during the study period. Baseline patient characteristics and procedure details are shown in Table 1. 59% of the patients were females. The median age was 64.5 years. Nineteen patients (56%) had a native papilla. The most common indication for the ERCP was choledocholithiasis (12, 35%) followed by benign biliary stricture (11,32%), head of pancreas tumor (6, 18%) and cholangiocarcinoma (4,12%).
28 out of 34 (82%) procedures achieved technical success. 20 procedures (59%) had the SUD used as the primary endoscope and 19 were successful (95%). In the other 14 cases (41%) SUD was used after the standard re-usable duodenoscopes due to anatomical problems encountered preventing progression of the procedure and of these 9 (64%) were completed successfully. In 5 of these (83%), failure occurred due to distorted duodenal anatomy which did not allow the scope to reach a favorable position.
Regarding the post procedure adverse events, 5 patients (15%) developed post procedure pancreatitis, two (5%) developed cholangitis and one patient (2%) had post sphincterotomy bleeding .

Conclusion

The SUD may be an effective tool in patients with distorted gastro-duodenal anatomy with failure when using a re-usable duodenoscopes. The reason for this may be due to the diameter and stiffness of the SUD. It was observed that SUDs are associated with comparably higher rates of adverse events in this study group due to the technical difficulty of the procedures. In addition to the fact that SUD eliminates the risk of device-related infection transmission, it appears to represent a reliable and effective alternative to standard re-usable duodenoscopes for a variety of indications and levels of difficulty.

Disclosure

Dr Corbett received honorarium from Boston Scientific previously.

Introduction

Diagnosing hepatic hilar malignancies is challenging due to the complex anatomical location and intricate nature of these lesions, necessitating advanced imaging modalities and specialised diagnostic approaches. To date, limited and dated studies with small sample sizes have focused on the diagnostic utility of endoscopic ultrasound fine-needle aspiration (EUS-FNA) in suspected malignancy of the hepatic hilum. However, only a few case series have reported similar findings for EUS fine-needle biopsy (EUS-FNB).

Aims & Methods

To address this gap, our study aims at assessing the diagnostic performance and safety profile of EUS-FNB a first-line tool in the diagnostic approach for suspected hepatic hilum malignancies. A single-centre, retrospective analysis of all the patients with biliary strictures and lesions involving the hepatic hilum who underwent EUS-FNB from October 2014 to April 2023 was conducted. All included patients were monitored after EUS-FNB via clinical follow-up for a minimum of 6 months or until death (follow-up <6 months). A descriptive statistical analysis for all the variables was performed. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were finally calculated.

Results

A total of 83 consecutive subjects (M:F 51:32, mean age 69.01±10.10) with a radiological suspicion of malignant lesion of the hepatic hilum were included in the analysis (details in Table 1). Sensitivity, specificity, PPV, and NPV were 88.00% (95%CI: 78.44-94.36), 100.00% (95%CI: 63.06-100.00), 100.00% (95%CI: 94.56-100.00), and 47.06% (95%CI: 32.50-62.13), respectively. Overall accuracy was 89.16% (95%CI: 80.41-94.92). The repetition of EUS-FNB after the first non-diagnostic one demonstrated increased sensitivity (92.00%, 95%CI: 83.40-97.01%) and overall accuracy (92.77%, 95%CI: 84.93-97.30%). Importantly, histological results were not affected by prior surgery of the upper gastrointestinal tract (n=5, p=0.083), or the presence of a biliary stent in place (n=19, p=0.728). The reported post-procedural adverse events were cholangitis (n=3, 3.6%) and mild pancreatitis (n=1, 1.2%).

Conclusion

This study emphasises the efficacy and safety of EUS-FNB as a first-line diagnostic tool for lesions of the hepatic hilum. Further prospective studies are warranted to determine the diagnostic performance of EUS-FNB for hilar lesions in comparison with ERCP-guided biopsies or brushing.

References

1. Navaneethan U, Njei B, Venkatesh PG et al. Endoscopic ultrasound in the diagnosis of cholangiocarcinoma as the etiology of biliary strictures: a systematic review and meta-analysis. Gastroenterol Rep (Oxf). 2015 Aug;3(3):209-15.