Clinical Outcomes of Multi-Hole Covered Self-Expandable Metal Stents for Malignant Distal Biliary Obstruction: A Retrospective Comparative Study With an Exploratory Evaluation of 6-mm Devices.
MHSEMS may be associated with fewer cholecystitis events and stent migration compared to conventional CSEMS, but further studies are needed to confirm these findings.
Where it sits
this study against the rest of the semax corpusSummary and findings
This study evaluated the clinical outcomes of multi-hole self-expandable metal stents (MHSEMS) versus conventional covered self-expandable metal stents (CSEMS) in patients with malignant distal biliary obstruction (MDBO). A total of 148 patients were included, with a median follow-up of 80.5 days for MHSEMS and 81.5 days for CSEMS. The study found that MHSEMS was associated with fewer cholecystitis events and migration compared to conventional CSEMS.
Abstract
<h4>Objectives</h4>Covered self-expandable metal stents (CSEMS) are widely used for malignant distal biliary obstruction (MDBO), but cholecystitis, post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), stent migration, and recurrent biliary obstruction (RBO) remain clinically important limitations. Multi-hole SEMS (MHSEMS) is a novel CSEMS designed to preserve side-branch drainage and reduce migration. We evaluated MHSEMS compared with conventional CSEMS and explored the potential impact of a newly available 6-mm MHSEMS.<h4>Methods</h4>This retrospective single-center study included consecutive patients who underwent initial transpapillary SEMS placement for MDBO between September 2015 and December 2025. Study-I compared MHSEMS versus conventional CSEMS limited to 8-10 mm diameter stents. Study-II included MHSEMS cases only and compared 6-mm versus 8-10 mm MHSEMS. Outcomes included cholecystitis, PEP, RBO, time to RBO (TRBO), and RBO causes.<h4>Results</h4>Study-I included 148 patients; median follow-up was 80.5 versus 81.5 days (<i>p</i> = 0.761). Overall cholecystitis was 1/34 versus 23/98 (<i>p</i> = 0.008). MHSEMS was independently protective for cholecystitis (odds ratio [OR] 0.0879; 95% confidence interval [95%CI] 0.0111-0.696), whereas cystic duct involvement increased risk (OR 3.190; 95%CI 1.160-8.720). PEP was 4/36 versus 18/112 (<i>p</i> = 0.595). RBO was 1/36 versus 28/112, including migration in 0 versus 9. TRBO was longer with MHSEMS (log-rank <i>p</i> = 0.023). Study-II included 64 MHSEMS cases; PEP was 1/28 versus 4/36 (<i>p</i> = 0.375), RBO was 1/28 versus 1/36, and no migration occurred.<h4>Conclusions</h4>MHSEMS was associated with fewer cholecystitis events and migration and longer TRBO versus conventional CSEMS. The potential benefit of 6-mm MHSEMS for reducing PEP remains exploratory and requires confirmation in longer prospective studies.
Background
This paper addresses the clinical limitations associated with conventional covered self-expandable metal stents (CSEMS) in the treatment of malignant distal biliary obstruction (MDBO). Previous studies have highlighted issues such as cholecystitis, pancreatitis, stent migration, and recurrent biliary obstruction (RBO) as significant concerns. The introduction of multi-hole self-expandable metal stents (MHSEMS) aims to mitigate these complications by preserving side-branch drainage.
Methods
This retrospective single-center study included consecutive patients who underwent initial transpapillary SEMS placement for MDBO from September 2015 to December 2025. Study-I compared MHSEMS to conventional CSEMS limited to 8-10 mm diameter stents, while Study-II focused solely on MHSEMS, comparing 6-mm to 8-10 mm devices. Outcomes measured included cholecystitis, post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), RBO, time to RBO (TRBO), and causes of RBO.
Results
In Study-I, the primary finding was that overall cholecystitis occurred in 1 out of 34 patients with MHSEMS versus 23 out of 98 patients with conventional CSEMS (p=0.008). MHSEMS demonstrated an odds ratio of 0.0879 for cholecystitis, indicating a protective effect. For PEP, the occurrence was 4 out of 36 for MHSEMS versus 18 out of 112 for CSEMS (p=0.595). RBO was recorded as 1 out of 36 for MHSEMS versus 28 out of 112 for CSEMS, with no migration in the MHSEMS group. TRBO was significantly longer with MHSEMS (log-rank p=0.023).
Interpretation
The findings suggest that MHSEMS may reduce the incidence of cholecystitis and stent migration compared to conventional CSEMS, which aligns with the goals of improving patient outcomes in MDBO management. However, while the statistical significance is noted, the clinical significance of these findings should be interpreted cautiously, particularly given the small sample size and the retrospective nature of the study. The lack of long-term follow-up and potential confounding factors limit the ability to draw definitive conclusions about the effectiveness and safety of MHSEMS in broader clinical practice.
Key findings
- Overall cholecystitis was 1/34 versus 23/98 (p=0.008).
- MHSEMS was independently protective for cholecystitis (odds ratio [OR] 0.0879; 95% confidence interval [95%CI] 0.0111-0.696).
- PEP was 4/36 versus 18/112 (p=0.595).
- RBO was 1/36 versus 28/112, including migration in 0 versus 9.
- TRBO was longer with MHSEMS (log-rank p=0.023).
Limitations
- retrospective study design
- single-center analysis
- limited follow-up duration of 80.5 days
- small sample size in some comparisons
- exploratory nature of 6-mm MHSEMS outcomes