Self-expandable absorbable biliary stents for liver transplant: progress and limitations

Biliary complications following liver transplant are a significant driver of postoperative morbidity and mortality, with the biliary anastomosis being relatively infamous among surgeons for its propensity for stricture and leak. Early complications at the biliary anastomosis represent ~10–30% of all complications following liver transplant and are responsible for a significant portion of mortality and graft failure (1-4). These complications are typically managed either endoscopically with stenting of the bile duct or via image-guided percutaneous drainage, though these procedures are certainly not without their own risks—post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, stent-associated cholangitis, and post-procedural hemorrhage are all well-known and appropriately feared by those managing patients who have recently undergone liver transplantation (5,6). In the interest of decreasing rates of biliary complications following liver transplant as well as avoiding postoperative procedures and their own associated complications, strategies to prevent these complications, particularly when a biliary anastomosis is identified to be high risk for early complications, are of extreme interest to those involved in the transplantation process.

A biliary anastomosis is typically considered “high-risk” if there is significant size mismatch between the donor and recipient, a very small duct diameter, extensive biliary reconstruction is required to achieve duct to duct anastomosis, tension at the anastomosis, or a very thin wall diameter of the bile duct (7). Several strategies have been previously trialed for prevention of complication at these high-risk anastomoses, though none are currently widely used in clinical practice. While placement of a T-tube initially appeared promising to manage the high-risk biliary anastomosis, this method has been associated with an increased incidence of biliary fistula and biliary peritonitis and is therefore suboptimal (1,8,9). A non-absorbable stent as a preventative measure at the time of surgery has been previously queried, though its use has been associated with largely equivalent clinical outcomes to no stenting along with increased rates of postoperative intervention and cost, and therefore has not been widely adopted (10,11). There is clearly no perfect strategy for the prevention of an early biliary complication in a high-risk anastomosis; similarly, there is not currently a consensus regarding their surgical management at the time of liver transplant. The authors of the study “Efficacy of Self-Expandable Absorbable Stents during Liver Transplant to Minimize Early Biliary Complications” aimed to tackle this issue, proposing a self-expanding absorbable biliary stent (SEABS) which may, if implanted at that time of whole graft liver transplant, provide a management strategy for the high-risk biliary anastomosis that does not require subsequent instrumentation of the anastomosis or retrieval (7).

The study provides evidence for SEABS as a viable method to decrease the rate of postoperative procedures as well as cost associated with liver transplant (7). As previously mentioned, endoscopic or image-guided management is the gold standard of treatment for many early postoperative biliary complications following transplant; although these procedures are highly effective, they are not without their own associated risks and costs, and should be minimized to both improve clinical outcomes and reduce cost associated with liver transplant (4-6,9). The data presented by the authors shows a decrease in number of ERCPs required (63 vs. 35) and a decrease in subsequent ERCP associated complications as well as radiologic drainages postoperatively in their SEABS patient population as compared to patients who either received a T-tube or no stent, though these were not always analyzed as statistically significant due to the low power of the study (7). These results are implicitly amplified by the resorbable nature of the biliary stent, its greatest strength, which negates the need for endoscopic retrieval. The cost analysis performed was limited to cost associated with biliary complications, and this data is likewise promising, showing a 50–67% decrease in costs associated with biliary complications in patients who received an SEABS vs. T-tube vs. no stent at the time of anastomosis (7). Additionally, the study notes an approximate 10% decrease in readmission, and significantly decreased length of hospital stay (15 vs. 19 days in SEABS vs. no SEABS groups), all of which indicate overall decrease in cost and burden on the hospital system (7). While this cost analysis and the above preliminary, low-power data is exciting, the relationship between the use of SEABS and the cost of liver transplant must be investigated using more comprehensive methods in order to derive meaningful conclusions.

These results also suggest decreased risk of early reoperation with only two patients who received an SEABS undergoing re-operation as compared to 13 within the no-SEABS group (7). This is remarkable as complications requiring reoperation have been shown to be associated with a higher risk for graft failure, increased morbidity, and increased mortality in the early postoperative period following liver transplantation and can occur secondary to biliary complication in up to ~5% of cases (12,13). Further, the authors have delivered preliminary, but promising results to describe an alternative, potentially lower-risk strategy for the management of a high-risk biliary anastomosis which may lead to prevention of biliary complications as their SEABS group had a rate of early biliary complication of only 2.6% with the no-SEABS group at 23.6% (7). Although this study does not show a significant difference in major complications (P=0.235) or mortality (unmeasured) between groups, it is not unreasonable to extrapolate from their findings that if SEABS do indeed decrease the rates of re-operation and overall biliary complications in the early postoperative period, both of which have been associated with increased morbidity and mortality surrounding liver transplantation, the use of SEABS may likewise decrease the overall morbidity and mortality of the procedure.

However, these promising results must be reviewed critically and within context. This is a single center non-randomized prospective study with relatively short-term (90-day) follow up and a relatively small sample size of only 158 patients. The authors themselves comment on some of the limitations of their study design which resulted in both a lack of statistical power and concerns regarding reproducibility given opportunity for patient selection bias. These concerns are further highlighted by a review of contemporary literature which shows minimal data with inconsistent results regarding the safe and effective use of SEABS as a preventative measure at the time of biliary anastomosis (14-16). While there is preliminary data suggesting that SEABS do not significantly increase the risk of biliary complications, particularly stricture, long term, there is certainly a paucity of data available to evaluate how the biliary anastomosis will be affected long term. Future studies may add to these results with the addition of randomization, long term follow-up, and the inclusion of multiple centers who serve variable patient populations.

Additionally, there are logistical issues with the use of this product in the clinical setting. There is currently only one SEABS available on the market clinically, the “ELLA-BD”, made up of polydioxanone. Per the authors of the study examined, these stents must be custom made to order from the manufacturer, and are not always readily available even upon ordering, presenting challenges for the time-sensitive world of liver transplant (7). With advances recently made and currently being made in normothermic machine perfusion (NMP) as well as manufacturing and availability improvements, some of these challenges regarding timing may be circumvented; however, challenges with regulation and legislation, particularly outside of Western Europe, present another significant obstacle to routine use globally as the stent is currently only available for clinical use in Europe, with no SEABS having currently achieved Food and Drug Administration (FDA) approval for use in the United States. As these stents become more widely available, the manufacturing process improves to allow for more practical clinical use, and clinicians across Europe become more accustomed to using this novel technology, we expect an increasing number of patients to receive these stents. Combined with careful collection of follow-up data and analysis, the currently limited use of these stents in Europe may further illustrate the risk/benefit profile and potentially allow for safe implementation globally.

Ultimately, although these results are promising and provide a potentially novel way to reduce biliary complications, re-operation, overall morbidity, length of hospital stay, and total cost associated with liver transplant, there is considerably more work to be done prior to consideration of implementation into routine clinical practice. Further evaluating the efficacy of SEABS, variations in technical considerations, and reproducibility of results as well as improving feasibility and manufacturing process improvement are all interesting areas of future consideration and investigation that the authors have illuminated with their findings.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, HepatoBiliary Surgery and Nutrition. The article has undergone external peer review.

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Funding: None.

Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://hbsn.amegroups.com/article/view/10.21037/hbsn-2025-579/coif). The authors have no conflicts of interest to declare.

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