Introduction

Post-endoscopic sphincterotomy bleeding is an adverse event of endoscopic retrograde cholangiopancreatography (ERCP). In some patients, the hemorrhage can be severe, occurring during ERCP, and difficult to resolve by standard endoscopic techniques (e.g., injection, thermals or clips). Fully covered self-expandable metal stents (FCSEMS) have been used to treat this complication. However, the studies are scarce, mostly with few patients, evaluating the efficacy and safety of these stents as a primary technique.

Aims & Methods

We aimed to evaluate the technical, clinical and safety success of using FCSEMS in the treatment of post-endoscopic sphincterotomy bleeding.
This was a retrospective cohort study, between September/2016 and April/2023, including all consecutive patients undergoing ERCP in which intra-procedural post-sphincterotomy bleeding occurred at our center. In all consecutive patients in whom active bleeding occurred FCSEMS were placed as primary therapy. Outcomes: (1) technical success; (2) clinical success (bleeding control); (3) recurrence of bleeding (up to 7 days); (4) adverse events. Descriptive and inferential exploratory analysis.

Results

FCSEMS were placed in 52 patients (38.5% male; median age 73 years (minimum 41-maximum 104), in a total of 3483 ERCP performed (2189 biliary sphincterotomy). Of the patients with bleeding, 21.2% (n= 11) were taking anticoagulants and 23.1% (n=12) were taking antiplatelet agents. The main indication for ERCP was lithiasis in 80.8% (n=42). Technical success and clinical success were 100%. In 4 patients there was recurrence of bleeding after ERCP (7.7%); new ERCP was performed in 3 of these, and a new FCSEMS was placed in 1 patient. No patient died or required surgical or interventional radiology treatment. In 13 patients it was found that FCSEMS had migrated (25%) at the time of scheduled removal.

Conclusion

The placement of fully covered self-expandable metal stents during ERCP is an effective and safe treatment for the control of post-sphincterotomy bleeding, with a low recurrence rate.

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for the treatment of choledocholithiasis. The key step for successful ERCP is selective biliary cannulation, however this fails in about 5-35% of cases. Pre-cut techniques emerged as a rescue for access to the biliary tract. As the length of biliary sphincterotomy after a fistulotomy (NKF) is shorter compared to standard cannulation, there is a theoretical possibility that treatment success will be lower when access is performed by NKF.
In this study, we intend to compare the efficacy and safety of biliary calculi removal between accesses by fistulotomy and standard cannulation.

Aims & Methods

Retrospective cohort study of 379 consecutive patients who underwent ERCP for choledocholithiasis between 2005 and 2022. Patients were selected from a prospective database and allocated into two groups (sample size assuming an effect size of 10%).
179 consecutive patients with choledocholithiasis who underwent NKF after failed cannulation (Group A), compared with 180 patients who underwent standard cannulation (Group B), adjusted for year of ERCP, stone size and number of stones.
Demographic data related to the procedure, adverse effects and the need for a new ERCP were evaluated.

Results

379 patients, 59.1% women, mean age 75.10 (26-97) years. Overall success rate of 87.07% on the CPRE index. 56 patients repeated ERCP with a success rate of 97.89%.
The success rate in group A was significantly lower compared to group B (p<0.003). Adverse events occurred in 6.60% of patients and did not differ significantly between the two techniques (p=0.307). Pancreatitis occurred in 3.7% of patients in group A and 5.1% in group B (p=0.340).
In the regression analysis (table 6) NKF cannulation was associated with a lower stone removal success rate compared with standard cannulation in the initial ERCP (odds ratio [OR] 0.34; 95% CI: 0.14-0.81; p=0.015). Stone size (10-15mm and >15mm) and having 4 or more stones were also predictors for a lower rate of stone removal in the initial ERCP (stone size 10-15 mm: OR 0.20, p=0.000; stone size >15 mm: OR 0.05, p=0.000; 4 or more stones: OR 0.4, p=0.040, respectively).

Conclusion

NKF is a rescue and expertise demanding technique, emerging has a savage approach when standard cannulation fail. However, was less effective than standard cannulation in the treatment of choledocholithiasis. Complications were similar in both groups.

References

Introduction

Distal malignant biliary obstruction (dMBO) is a frequently occurring condition that requires immediate intervention. The primary treatment for dMBO comprises endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent insertion^​. The European Society of Gastrointestinal Endoscopy recommends the use of self-expandable metal stents (SEMS) for palliative drainage of dMBO because of their superior patency and reduced incidence of adverse events (AEs), including recurrent biliary obstruction, compared to those of plastic stents^​. Three types of SEMS are available: uncovered SEMS (UCSEMS), fully covered SEMS (FCSEMS), and partially covered SEMS. However, the ideal stent type for palliative drainage of dMBO remains undetermined. Several studies have compared UCSEMS with FCSEMS to determine which type is most appropriate for dMBO^​. In terms of patency, some prospective trials have shown that FCSEMS result in better outcomes^​; however, others have observed similar results with UCSEMS and FCSEMS^​. Most studies have primarily focused on pancreatic cancer cases; however, the pathophysiology of pancreatic cancer and that of nonpancreatic cancer differ significantly, resulting in inconsistent outcomes. Post-ERCP pancreatitis (PEP) is the most common and serious AE associated with the transpapillary placement of SEMS, with an incidence rate of up to 10.8%^​. Therefore, studies have aimed to identify the risk factors for PEP after SEMS placement. Compared to UCSEMS placement, FCSEMS placement may be more strongly linked to a higher risk of PEP because they block the pancreatic duct orifice more effectively. Additionally, nonpancreatic cancer has been identified as a potential risk factor for PEP^​. Therefore, FCSEMS placement for nonpancreatic cancer cases is associated with a significantly higher risk of PEP. We examined the safety of UCSEMS for dMBO caused by nonpancreatic cancer and observed a low PEP rate, even for nonpancreatic cancer cases^​. However, a comparison of UCSEMS and FCSEMS is still required because no studies have evaluated their use for dMBO caused by nonpancreatic cancer. Therefore, this study evaluated the efficacy and safety of UCSEMS and FCSEMS for palliative drainage of dMBO caused by nonpancreatic cancer.

Aims & Methods

This retrospective multicenter study included patients who underwent UCSEMS or FCSEMS placement for nonpancreatic cancer-induced dMBO at four centers between January 2010 and April 2024. Propensity score matching (1:1) of the UCSEMS and FCSEMS groups was performed. Technical and clinical success, AEs, recurrent biliary obstruction (RBO), time to RBO (TRBO), and overall survival (OS) of these groups were compared.

Results

No significant differences in technical success (100% for both), clinical success (100% for both), and TRBO (median: 311 days [UCSEMS] vs. 317 days [FCSEMS]; p=0.42) were observed between groups. Similarly, OS did not differ significantly (median: 432 days [UCSEMS] vs. 190 days [FCSEMS]; p=0.083). The incidence of postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) of the UCSEMS group was significantly lower than that of the FCSEMS group (4.2% vs. 33%; p=0.023).

Conclusion

compared to FCSEMS, UCSEMS provided sufficient patency and reduced AEs associated with dMBO caused by nonpancreatic cancer. The cause of dMBO should be carefully considered when choosing the optimal stent. UCSEMS may be safer and more effective than FCSEMS for the treatment of nonpancreatic cancer cases.

Disclosure

Authors declare no conflict of interests for this article.

Introduction

For distal malignant biliary obstruction (dMBO) self-expandable metal stents (SEMS) have shown improved patency over plastic stents. Whilst initial data suggest that Covered versus Uncovered SEMS increase Time to Recurrent Biliary Obstruction (TRBO), no data is available for Fully-Covered (FC) versus Partially-Covered (PC) design.

Aims & Methods

Pubmed, Scopus and Cochrane databases were screened from inception to January 2023 for all studies describing adult patients with dMBO, treated by endoscopic placement of FC or PC-SEMS and describing Adverse Events (AEs), Recurrences or TRBO for the specific stent subpopulation. A random-effects meta-analysis was performed following PRISMA checklist, reporting outcomes as pooled proportions or means [95% confidence interval (95%CI)]. Sub-analyses restricted to 1) prospective studies, 2) unresectable diseases, 3) pancreatic cancers were pre-planned. Heterogeneity and Publication bias were explored through I² statistic and LFK index respectively. Standardized differences (d-values) were calculated between the two groups (CRD42023393965).

Results

From 1290 records, 62 studies (3327 patients with FC-SEMS and 2322 patients with PC-SEMS) were included.
Comparison of FC versus PC-SEMS showed negligible differences (d-values<0.1) in the rate of total AEs (12% vs. 9.9%) and all specific adverse events, including cholecystitis (2.5% vs. 2.6%).
In prospective studies, total recurrences were similar between FC-SEMS (21.5% [16.8-26.5], I²=72.5%) versus PC-SEMS (25.6% [20.6-30.9], I²=84.5%), despite small differences (0.117-d-values-0.215) in the rate of ingrowth (0.2% vs 2.8%) favouring FC-SEMS and migration (7% vs 4.3%) favouring PC-SEMS. These results were confirmed amongst unresectable diseases, with even a small difference in total recurrences (30.7% versus 25.9%) favouring PC-SEMS.
In prospective studies, TRBO was estimated to be longer for PC-SEMS (369 [290-449] days, I²=71.9%) versus FC-SEMS (219 [165-273] days, I²=93.3%; d-value=0.129 [small difference]), with consistent results in unresectable diseases.

Conclusion

FC-SEMS and PC-SEMS seem comparable in terms of AEs (including pancreatitis and cholecystitis) and recurrences, as migrations of FC-SEMS are compensated by ingrowths of PC-SEMS. Despite high heterogeneity and small standardized differences, PC-SEMS showed longer patency in prospective studies and amongst unresectable malignancies, potentially advising head-to-head comparison in this scenario.

References

FC-SEMS and PC-SEMS seem comparable in terms of AEs (including pancreatitis and cholecystitis) and recurrences, as migrations of FC-SEMS are compensated by ingrowths of PC-SEMS. Despite high heterogeneity and small standardized differences, PC-SEMS showed longer patency in prospective studies and amongst unresectable malignancies, potentially advising head-to-head comparison in this scenario.

Introduction

It is recognised that large common bile duct (CBD) stones present a significant challenge in endoscopic practice. A key performance indicator of >80% clearance at the initial ERCP has been recommended to standardise quality of care. Standard techniques such as sphincterotomy +/- balloon sphincteroplasty are usually sufficient; however, in difficult cases, plastic stents are frequently placed to maintain biliary drainage, with elective repeat ERCP planned. When clearance remains unsuccessful, options such as mechanical lithotripsy or cholangioscopy may be employed, though these are often limited to tertiary care centres. Fully covered self-expanding metal stents (FCSEMS) have been proposed as a novel strategy to remodel the distal CBD and facilitate stone retrieval at subsequent procedures. While this approach is not currently included in formal UK guidelines, its use is expanding in complex cases. We report our early experience comparing plastic stents alone with a combination of fully covered metal stents and coaxial plastic stents in a secondary care setting.

Aims & Methods

This was a retrospective observational study conducted at a large secondary care NHS trust. We included patients undergoing ERCP between 2019 and 2024 in whom complete stone clearance could not be achieved at the initial procedure and a stent was placed. Only patients with confirmed choledocholithiasis and naïve papillae at first ERCP were included. All patients had large CBD stones, defined as stones greater than 10 mm in diameter. Patients were categorised according to whether a plastic stent alone or a fully covered metal stent with coaxial plastic stent was used at the index procedure. A 7Fr pigtail plastic stent was used in all cases; for the FCSEMS group, a fully covered metal stent was inserted with a plastic stent placed through it. Data were collected from endoscopy records and electronic patient notes. Outcomes assessed included complete stone clearance at second ERCP, need for mechanical lithotripsy, number of ERCP procedures, and referral to tertiary care for cholangioscopy. Fisher’s exact test and unpaired t-tests were used for statistical analysis.

Results

A total of 63 patients were included, with 46 in the plastic stent group and 17 in the FCSEMS group. Complete stone clearance for large stones (>10 mm) at second ERCP was achieved in 63.0% of patients in the plastic group compared with 76.5% in the FCSEMS group (p=0.380). Mechanical lithotripsy was required in 8.7% of plastic stent cases and 5.9% of FCSEMS cases (p=1.000). Referral to tertiary care for cholangioscopy occurred in 30.4% of the plastic group and 11.8% of the FCSEMS group (p=0.195). The mean number of ERCPs per patient was similar between groups, with an average of 2.50 procedures in the plastic group and 2.41 in the FCSEMS group (p=0.601).

Conclusion

The use of fully covered metal stents with coaxial plastic stents was associated with promising trends, including higher rates of complete stone clearance for large CBD stones and fewer referrals to tertiary centres. Although these findings did not reach statistical significance, they suggest a clinically relevant benefit that merits further investigation. The higher observed clearance rate and reduced need for cholangioscopy may support FCSEMS as a valuable adjunct in managing difficult bile duct stones. These results should be interpreted cautiously given the small size of our dataset, but they provide an encouraging basis for future prospective studies aimed at optimising CBD stone management and potentially reducing the need for tertiary care referral.

Disclosure

Nothing to disclose

Introduction

Cholangioscopy-assisted intraductal lithotripsy is a first-line option in the treatment of complex gallstones. Its effectiveness and safety are demonstrated in the literature by multiple studies published after 2017.
However, there are no published studies about the long-term recurrence of choledocholithiasis in patients treated by these techniques.
With this study we intend to answer this question, evaluating the long-term recurrence of choledocholithiasis in patients with complex choledocholithiasis treated with intraductal lithotripsy techniques.

Aims & Methods

Retrospective cohort study of 62 consecutive patients who underwent cholangioscopy-guided intraductal lithotripsy between 2017 and 2022 at our center. Data were collected from a dedicated prospectively maintained database.
Primary outcome: recurrence of choledocholithiasis. Follow-up time: 5 years.
Survival analysis was performed using Kaplan-Meyer curves and Cox regression (Statistical software STATA 17 (StataCorp, TEXAS).

Results

Of the 62 patients, 35 (56.5%) were women, mean age 72 years (min. 28, max. 96), 20 of whom had previously undergone cholecystectomy and with a mean follow-up time after lithotripsy of 28.21 months . 88.7% of patients achieved complete stone removal in the 1st session, with a rate of 100% at the second procedure. The mean number of stones was 2.02 with a size of 18.74mm. There was recurrence of choledocholithiasis in 9 patients, of which 77.8% had cholangitis, with a mean time of 13.33 months after lithotripsy. In patients with recurrence of choledocholithiasis, 22.2% had gallbladder. None of the patients required surgery to explore the biliary tract.

Conclusion

Cholangioscopy-guided lithotripsy is associated with a high success rate in difficult gallstones, with a safety profile similar to conventional techniques and lower rates of choledocholithiasis during follow-up.