Introduction

Biliary drainage (BD) in patients with distal malignant biliary obstruction (DMBO) implies a higher risk of difficult biliary cannulation (DBC) during endoscopic retrograde cholangiopancreatography (ERCP). When standard techniques, (sphincterotome, and guidewire) fail, the endoscopist may proceed with advanced cannulation techniques, such as the double
guidewire technique, needle-knife precut papillotomy or fistulotomy, and transpancreatic sphincterotomy. Despite the higher risk of adverse events, these advanced strategies can still fail in
up to 15% of cases. In recent times, endoscopic ultrasound-guided biliary drainage (EUS-BD) emerged as a viable alternative in case of DBC due to its favorable profile in terms of both technical success, and safety.

Aims & Methods

Multi-center (4 centers), international (Italy, France), retrospective, propensity score-matched study including patients with DMBO, and common bile duct (CBD) diameter >12mm. DBC cases managed with either advanced cannulation techniques (aERCP group), or direct EUS- guided approach (performed straight away after failure of standard cannulation; EUS-BD group) were considered for the analysis. A 2:1 propensity score-matched analysis was performed balancing age, sex, and CBD diameter to reduce confounding, and ensure comparability between groups. The outcomes of interest were the rates BD failure, clinical success, and adverse events (AEs).

Results

Standard cannulation techniques failed in 524 cases during the study period. Advanced cannulation techniques, and EUS-guided approach were attempted in 472, and 52 cases, respectively. After matching, 76 (aERCP group), and 38 patients (EUS-BD group) were included in the analysis (age: 77.4+10.5 and 76.7+12.6, male: 70.6% vs 71.1%, CBD diameter: 16.5+2.9 and 17.2+3.3, respectively). In aERCP group, also advanced cannulation techniques failed in 17 22.4%) cases, however all these patients were successfully treated by EUS-guided approach as a rescue strategy. No cases of BD failure were reported in EUS-BD group (p<0.05). Clinical success was comparable between the two groups (aERCP:91.2%, vs EUS-BD:94.7%, p=0.46). The 20.6% of patients experienced AEs in the aERCP group (7 cholangitis, 6 pancreatitis, 2 bleeding, 2 other), compared to the 7.9% reported in EUS-BD group (2 cholangitis, 1 pancreatitis, 1 bleeding; p=0.14).

Conclusion

EUS-guided biliary drainage shows higher technical success rate compared to advanced cannulation techniques, with comparable clinical success. Regarding safety, the observed trend of reduced adverse events (AEs) with the EUS-guided approach may require a larger, adequately powered study to confirm statistical significance. In patients with dilated CBD (>12mm).
EUS-BD may be considered an efficient option in case of DBC, possibly minimizing the risk of adverse events.

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most demanding and high-risk endoscopic procedures.
Failures and complications are more common than we realise, they lead to low satisfaction for the patient, high frustration for the endoscopist, higher risks of more instrumentalization in further re-attempts.

Keeping a meticulous updated data logging is fundamental to understand how we perform, what specific factors predict our failures, and identifying areas of improvement, mistakes or learning opportunities.

Aims & Methods

This prospective cohort study was conducted over a 3-year period (September 2020 to January 2024) at a tertiary care centre.
We defined all the adverse events as per ESGE guidelines¹ The 30- mortality was analysed and stratified based on relation to ERCP.
We also identified patients’ factors (Age, sex, frailty, NEWS>4, anticoagulation, antiplatelets, palliative) and technique (First pass cannulation, double wire, precut sphincterotomy, sphincteroplasty). Descriptive statistics, chi-square or t-tests were used to evaluate associations between clinical characteristics and outcomes.

Results

A total of 438 patients underwent ERCP by the single operator during the study period. Procedural success was achieved in 389 cases (88.9%) and in 100% of cases of non-native ampulla. Success rates were lower in malignant cases (80.6%) compared to benign cases (90.05%) with an odds ratio (OR) of 2.21 (CI 1.05–4.63, p = 0.03).
Complications included: Post-ERCP pancreatitis: 12/438 (2.74%) Infections: 4/438 (0.91%) (3 cholangitis, 1 cholecystitis) Perforation: 3/438 (0.68%) and Bleeding: 2/438 (0.45%)
Mortality within 1 month was 17/438 (3.88%) mostly unrelated to the procedure in palliative and frail patients. Procedure-related mortality occurred in 4 cases (0.91%),due to pancreatitis (n=2),perforation (n=1) and sepsis secondary to cholecystitis (n=1).
Of all conscious sedation, only 204 /423 (48.2%) were deemed comfortable. 174/423 (41.1%) had mild discomfort, 32/423 (7.5%) had significant discomfort and 13/423 ( 3.07%) severe or very poor. Female patients demonstrated higher risk of poor tolerance (OR 2.09, CI 1.05–4.18 p = 0.04) but no higher procedural failure.
In difficult cannulation, double-wire succeeded in 19/36(52.8%). When combined with additional techniques after initial failure, success increased to 77.8%. Pre-cut sphincterotomy succeeded only in 13/25( 52%) lower than data published (>75%), thought to be due to learning curve and limited patient tolerance. However, pre-cut helped cannulation in most follow-up ERCPs .
Double wire associated risk of post-ERCP pancreatitis -but exclusively when prophylactic pancreatic duct stent was not placed-OR 3.96 (CI 1.02-15.3) p=0.04. None other AEs were significantly associated with any advanced cannulation techniques.

Conclusion

Overall failure rates and AEs were consistent with published literature. Statistically significant risks of failure included malignant aetiology (OR 2.21) and poor tolerance (OR 2.20). Female sex associated higher intolerance (OR 2.09). Both double-wire and pre-cut sphincterotomy showed failure rates of approximately 50%. Frailty was a significant predictor of 30-day mortality (OR 4.83).

References

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