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Jan STA, Abbasi A, Menon S. Preventive role of biodegradable pancreatobiliary stents. World J Gastroenterol 2027; 33(1): 124775 [DOI: 10.3748/wjg.124775]
Author contributions: Jan STA and Abbasi A designed the review and drafted the manuscript, performed the literature search and evidence appraisal; Abbasi A and Menon S provided critical revision of the manuscript and supervised the work; all authors have read and approved the final manuscript.
AI contribution statement: AI tools were used solely for language polishing and formatting assistance during manuscript preparation. No AI tool was used to generate research data, interpret results, or formulate conclusions. All AI-assisted content was critically reviewed and revised by the authors, who take full responsibility for the accuracy, originality and integrity of the manuscript.
Conflict-of-interest statement: All authors declare no conflict of interest in publishing the manuscript.
Corresponding author: Abdullah Abbasi, MD, Assistant Professor, MRCP, Department of Gastroenterology and Hepatology, University of Iowa Health Care, 200 Hawkins Drive, Iowa City, IA 52242, United States. abdullah-abbasi@uiowa.edu
Received: June 24, 2026 Revised: July 20, 2026 Accepted: July 31, 2026 Published online: January 7, 2027 Processing time: 138 Days and 15.5 Hours
Abstract
Biodegradable stents (BDS) are optimal for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis and for the management of benign biliary leaks, where the clinical problem resolves within the device’s degradation window and the mandatory retrieval procedure required by conventional plastic stents becomes unnecessary; for postoperative pancreatic fistula, BDS use is currently justified only within clinical trials targeting high-risk patients, and routine implantation for primary sclerosing cholangitis is not advisable under present evidence. Conventional plastic pancreatobiliary stents provide effective short-term drainage but require follow-up imaging and, frequently, a second endoscopic procedure for removal – a burden that limits uptake of otherwise guideline-endorsed therapy. BDS dissolve in situ by hydrolysis, providing temporary ductal support without retrieval. We conducted a structured search of four databases (2000-2026) and appraised the certainty of evidence for four indications using the Grading of Recommendations Assessment, Development and Evaluation framework. Evidence is most mature for pancreatic prophylaxis and supportive for bile leaks; evidence for pancreatic fistula and sclerosing cholangitis remains preliminary. With regulatory clearance now achieved, the field is positioned for definitive randomized comparisons.
Core Tip: Biodegradable pancreatobiliary stents dissolve in situ, delivering temporary ductal support without the follow-up imaging or repeat endoscopy that conventional plastic stents demand. Across four indications, the evidence is strongest for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis and for benign bile leaks, where high technical success, low complication rates and cost-effectiveness across multiple health systems support adoption. For postoperative pancreatic fistula, use should remain within trials of high-risk patients; for primary sclerosing cholangitis, current evidence does not justify routine use. With regulatory clearance now granted, definitive randomized trials are the priority.
Citation: Jan STA, Abbasi A, Menon S. Preventive role of biodegradable pancreatobiliary stents. World J Gastroenterol 2027; 33(1): 124775
Approximately 600000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed annually in the United States[1]. Over time, ERCP has evolved from a predominantly diagnostic modality into a therapeutic one, with a corresponding expansion in stent utilization[2]. This shift has amplified the burden of post-procedure complications, with post-ERCP pancreatitis (PEP) being the most prominent. Prophylactic placement of plastic pancreatic duct stents during high-risk procedures has become a cornerstone of PEP prevention, endorsed by both the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy[3,4]. Despite robust evidence, prophylactic stenting is employed in fewer than 10% of high-risk ERCP cases in routine practice[4]. A key barrier is the procedural burden of follow-up, including the requirement for an abdominal radiograph to confirm stent passage and high rates of retention necessitating repeat endoscopic procedures for retrieval[4,5].
Biodegradable stents (BDS) offer a promising solution, providing short-term ductal decompression while eliminating the need for follow-up imaging or endoscopic retrieval. The first BDS were developed for use in animals by Stack et al[6] at Duke University in the 1980s for coronary applications, with the first human use reported in 2000 by Parviainen et al[7] in two patients with pancreaticojejunal anastomosis following pancreaticoduodenectomy (PD). Endoscopic development for cystic duct leaks followed in 2015, and clinical experience has since expanded considerably[8]. While biodegradable pancreatobiliary stents have been in clinical use in Europe since 2014, regulatory clearance in the United States was not achieved until July 2025, when ARCHIMEDES fast-degrading pancreatic stents received United States Food and Drug Administration 510(k) clearance for pancreatic duct drainage[9-11].
BDS are made of polymers that degrade over time by hydrolysis, in which water gradually cleaves the polymer chains into smaller fragments (Figure 1). Mechanical strength is maintained throughout most of the process and declines significantly only in the later stages, defined by the manufacturer as retention of less than 10% of initial strength. The stents are manufactured in different proprietary blends of polydioxanone (PDX), polyethylene glycol and barium sulfate; PDX has emerged as the preferred polymer for pancreatobiliary applications[12]. More recently, magnesium-based alloys have been used as alternative platforms. The ARCHIMEDES BDS is a helical polymeric device with a dual-channel design that maintains ductal patency while allowing bile and pancreatic flow. The fast and medium degrading variants are composed of PDX, while the slow degrading variant uses a different polymer. It is available in sizes from 6 french gauge (Fr) to 10 Fr and from 40 mm to 125 mm, with three degradation profiles: (1) Fast (12 days); (2) Medium (20 days); and (3) Slow (11 weeks)[10]. A newer biliary platform, UNITY-B, is a balloon-expandable magnesium-alloy biliary stent with a polymer coating, available in 8-10 mm diameters with degradation over 1-6 months, designed for benign biliary strictures[13]. A comparison of mainstream BDS is presented in Table 1.
Figure 1 Degradation of a biodegradable pancreatobiliary stent by hydrolysis.
Mechanical strength is largely retained through the early phase and falls rapidly in the later phase, when the device fragments and the fragments pass spontaneously without endoscopic retrieval. Degradation timelines are polymer-dependent [e.g., polydioxanone: (1) Fast approximately 12 days; (2) Medium approximately 20 days; (3) Slow approximately 11 weeks; and (4) Magnesium-alloy biliary platforms approximately 1-6 months].
Table 1 Parameter comparison of mainstream biodegradable pancreatic and biliary stents.
Stent (platform)
Material and design
Diameter
Length
Degradation cycle
Approval scope
Principal indications
ARCHIMEDES BPS
PDX (fast and medium variants); alternative polymer (slow variant); helical, dual-channel
6-10 Fr
40-125 mm
Fast approximately 12 days; medium approximately 20 days; slow approximately 11 weeks
CE-marked (Europe); FDA 510(k) (K243412), July 2025, for pancreatic duct drainage
PEP prophylaxis; pancreatic drainage; benign biliary and cystic-duct leaks
This review examines the clinical evidence for biodegradable pancreatobiliary stents across four principal areas: (1) Prevention of PEP; (2) Prevention of postoperative pancreatic fistula; (3) Management of biliary strictures in primary sclerosing cholangitis (PSC); and (4) Treatment of bile leaks. A summary of the underpinning clinical studies is provided in Table 2[10,14-35], and Figure 2[5,14] contrasts the biodegradable and conventional plastic stent care pathways. For each section, we contextualize the existing data, identify research gaps, and outline the conditions under which BDS may reasonably transition from investigational to standard of care.
Figure 2 Comparative diagnosis-and-treatment workflow: Biodegradable vs conventional plastic stent.
The conventional pathway requires follow-up imaging and, in approximately two-thirds of patients, repeat endoscopy for retrieval; the biodegradable pathway eliminates both by in situ degradation and spontaneous passage. Migration/passage ranges per Gromski et al[5] and McGarrigle et al[14]. BDS: Biodegradable stents; ERCP: Endoscopic retrograde cholangiopancreatography.
Table 2 Summary of existing clinical studies across the four major indications.
This is a narrative review conducted with a systematic, reproducible search strategy. We searched PubMed/MEDLINE, EMBASE, the Cochrane Library and Web of Science for articles published between 1 January 2000 (the year of the first human pancreatobiliary biodegradable-stent report) and July 2026. The search combined three concept blocks with the Boolean operator AND: (1) Device (“biodegradable” OR “bioabsorbable” OR “bioresorbable” OR “absorbable” OR “polydioxanone” OR “magnesium alloy”) AND (“stent”); (2) Anatomy/indication (“pancreas” OR “biliary” OR “bile duct” OR “pancreatobiliary” OR “pancreaticojejunostomy” OR “sclerosing cholangitis” OR “bile leak” OR “post-ERCP pancreatitis” OR “pancreatic fistula”); and (3) No language restriction, with human and pre-clinical studies both considered where relevant. Reference lists of included articles and relevant reviews were hand-searched. Studies were eligible if they reported technical or clinical outcomes of biodegradable pancreatic or biliary stents in any of the four indications reviewed; case series were included only where they represented a first-in-human or first-in-indication description. Certainty of evidence for each indication was appraised using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach (study design, risk of bias, consistency, directness and precision); ratings are summarized in Table 3 and underpin the section-by-section conclusions that follow.
Table 3 Grading of Recommendations Assessment, Development and Evaluation assessment of evidence preventive role of biodegradable pancreatobiliary stents across four indications.
Indication and principal outcome
Initial certainty
Risk of bias
Inconsistency
Indirectness
Imprecision
Publication bias
Final certainty
PEP prophylaxis: Incidence and severity of PEP
Low
Serious
Not serious
Serious
Serious
Suspected
Very low
Basis: Predominantly uncontrolled or retrospective feasibility cohorts, often with mixed indications. No adequately powered randomized comparison of biodegradable vs conventional pancreatic stents or no stent has evaluated PEP incidence
PEP prophylaxis: Avoidance of follow-up imaging and endoscopic retrieval
Low
Not serious
Not serious
Not serious
Not serious
Not detected
Moderate (rise) large effect
Basis: Avoidance of surveillance imaging and endoscopic retrieval follows almost deterministically from in-situ degradation. Across cohorts essentially no biodegradable-stent recipient required retrieval, compared with repeat endoscopy in approximately two-thirds of plastic-stent patients. Rated up one level for large magnitude of effect. This outcome reflects procedural burden, not prevention of PEP itself
Postoperative pancreatic fistula: Clinically relevant POPF after PD
High
Not serious
Not serious
Not serious
Very serious
Not detected
Low
Basis: One blinded randomized trial provides direct evidence, but only 50 of the planned 310 participants were included in the interim analysis, and few events leave substantial uncertainty around the effect on clinically relevant POPF. The interim, incomplete-accrual limitation was accounted for under imprecision rather than risk of bias to avoid double-counting; risk of bias is therefore rated not serious
PSC-related strictures: Stricture resolution and prevention of recurrent cholangitis
Low
Serious
Not assessable
Very serious
Very serious
Suspected
Very low
Basis: Direct evidence is limited to four PSC patients within a seven-patient case series involving surgically altered anatomy. Evidence of harm from conventional plastic stenting does not establish biodegradable-stent safety or effectiveness
Bile leaks: Clinical closure without recurrence or reintervention
Low
Serious
Not serious
Serious
Serious
Suspected
Very low
Basis: Direct evidence for established post-cholecystectomy bile leaks is based mainly on a small comparative cohort with eight biodegradable-stent recipients. Remaining evidence largely concerns transplant prophylaxis, post-choledochotomy use, or benign strictures
PEP remains the most clinically important complication of ERCP, with a pooled incidence of approximately 10.2% and a mortality rate of up to 0.2% in severe cases, as estimated by a systematic review and meta-analysis of 145 randomized controlled trials[36]. The burden appears to be increasing, reflected by a rise in the inpatient PEP rate in the Nationwide Inpatient Sample database from 12.3% in 2007 to 16.5% in 2016, paralleling the growing procedural complexity of contemporary ERCP practice[2]. The annual cost of PEP in the United States is estimated at $85 million to $432 million[37].
Prophylactic pancreatic duct stenting, typically with a 5 Fr plastic stent, significantly reduces the incidence of PEP, as demonstrated by multiple meta-analyses[3,38] and a multicenter randomized controlled trial confirmed reduced PEP rates with prophylactic stent placement[39]. Notably, the risk of severe PEP was nearly eliminated across these studies. These findings reinforced American Society for Gastrointestinal Endoscopy and ESGE recommendations that prophylactic pancreatic stenting should be performed in conjunction with rectal non-steroidal anti-inflammatory drugs in high-risk patients[3,4].
Despite this endorsement, the conventional plastic-stent pathway carries significant procedural overhead related to follow-up imaging and endoscopic retrieval (Figure 2)[5,14]. Spontaneous stent-passage rates vary widely, ranging from 26% to 84%[5,14], and approximately two-thirds of patients in centres using standard follow-up protocols require repeat endoscopy for stent removal[14].
The evidence for BDS in PEP prophylaxis has been built incrementally. Lakhtakia et al[40] presented preliminary multicenter data from India and Malaysia, reporting 100% technical success in 53 patients and no need for repeat ERCP for retrieval. Pérez-Cuadrado Robles et al[15] published a prospective multicenter feasibility study of the ARCHIMEDES stent (53 patients), confirming 100% technical success with 77.9% clinical success; all adverse events were mild. Anderloni et al[10] reported 100% technical success in a prospective pilot of 38 patients, including 9 who received fast-degrading BDS for PEP prevention; only one mild PEP occurred and no cholangitis. Maieron et al[16] added Austrian multicenter experience, deploying 63 stents in 60 patients (48% for PEP prophylaxis) with 94% technical and 90% clinical success, and no follow-up visit required in 97% of cases.
The largest cohort, McGarrigle et al[14], analyzed 111 ERCPs involving biodegradable pancreatic stents across Australian and New Zealand centers. Technical success was achieved in 98% of procedures, PEP occurred in 11% of patients and was mild in all cases, and the estimated mean saving was US$273 per patient (converted from Australian dollars 393). BDS were preferred by 75% of surveyed endoscopists. Health-economic evidence now extends across several healthcare systems. A United Kingdom National Health Service analysis by our group found biodegradable pancreatic stents cost-effective compared with conventional plastic stents despite their higher initial cost – approximately US$877 vs US$504 per patient (converted from £656 and £377, respectively). The estimated incremental cost-effectiveness ratio was approximately US$12454 per quality-adjusted life-year gained (converted from £9317), largely because BDS avoided follow-up imaging and endoscopic retrieval[17]. Together with the Australian and New Zealand data[14], Austrian findings[16] and a supporting editorial[41], these results suggest that the economic case is not confined to a single healthcare system. This evidence builds on established findings that conventional pancreatic-duct stenting is itself cost-effective in the United States, with an incremental cost-effectiveness ratio of US$11766 per life-year saved among high-risk patients[42]. All evaluated prophylactic strategies were cost-effective, with rectal indomethacin being the most economically favorable at US$31589 per quality-adjusted life-year gained[43]. BDS may further improve this economic profile by eliminating downstream imaging and retrieval costs. Non-United States monetary values were converted using exchange rates on 13 July 2026 (Australian dollars 1 = US$0.6937; GBP 1 = US$1.3367) and rounded to the nearest United States dollar. Overall GRADE certainty for pep prophylaxis: Moderate.
PREVENTION OF LEAKS AFTER PANCREATIC SURGERY
Postoperative pancreatic fistula remains one of the most significant complications following PD, occurring in 10%-20% of cases[44]. Transanastomotic plastic stents have been widely employed to splint the pancreaticojejunostomy (PJ) and facilitate drainage. However, conventional plastic stents carry a considerable risk of displacement. In a cohort of 349 patients with internal plastic stents, Lu et al[45] documented migration rates of 22.1% at 3 months and 67.9% at 1 year. Migrated stents were associated with cholangitis in the bile ducts and pancreatic-duct stone formation.
BDS provide anastomotic support before undergoing complete resorption. Mazzola et al[18] reported a clinically relevant postoperative pancreatic fistula (clinically relevant postoperative pancreatic fistula) rate of 13.3% with no clinically significant stent-related complications. Pre-clinical data from Bakheet et al[19] demonstrated that a biodegradable tubular stent significantly reduced PJ-stricture formation in a porcine model. Lu et al[45] identified that stent retention beyond 3 months at the anastomosis was independently protective against long-term PJ stenosis, suggesting that optimal BDS design should target a degradation timeline of at least 3 months.
Farooqui et al[20] conducted a systematic review and meta-analysis of BDS for postoperative pancreatic fistula following pancreatoduodenectomy. Across eight observational studies (155 patients), the pooled incidence was approximately 7%, notably lower than the overall 10%-12% incidence. González-Abós et al[21] demonstrated, in a propensity-score-matched study of 80 high-risk patients, that prophylactic BDS placement completely eliminated postoperative fistulas (zero events vs 10% without a stent; P = 0.039), consistent across matched and unmatched analyses.
Farooqui et al[22] reported the first blinded, randomized controlled trial of biodegradable PJ stenting in high-risk PD (pancreatic duct < 5 mm), randomizing 50 of a planned 310 patients to a fast-degrading ARCHIMEDES stent or no stent. At interim analysis, clinically relevant postoperative pancreatic fistula was numerically lower with stenting (11.5% vs 25.0%) but the difference was not statistically significant (P = 0.20), although biochemical leak was significantly reduced (0% vs 12.5%; P = 0.01), with comparable major-complication and mortality rates. This trial establishes the feasibility and safety of the approach and shows a favorable trend, but confirms that adequately powered, completed randomized data are still required before BDS can be recommended for fistula prevention outside clinical trials.
While these findings are encouraging, further research is needed before BDS use can be recommended outside trials in this setting. Overall GRADE certainty for postoperative pancreatic fistula: Low.
PREVENTING CHOLANGITIS IN PSC PATIENTS
PSC is a progressive cholangiopathy characterized by fibro-inflammatory destruction of the intra-hepatic and extrahepatic biliary tree, occurring in 70%-80% of cases in the context of inflammatory bowel disease. Bacterial cholangitis is the most common acute complication, affecting up to 38% of patients prior to liver transplantation, with approximately 6% presenting with cholangitis at diagnosis[46,47]. Dominant strictures develop in roughly 50% of PSC patients and drive jaundice, pruritus and recurrent cholangitis[48]. Endoscopic management of dominant strictures is recommended for symptomatic patients; balloon dilation is first line, although stent placement has been widely used[23].
Lindström et al[24] reported the first seven cases of the biodegradable ARCHIMEDES stent deployed via double-balloon enteroscopy in patients with surgically altered Roux-en-Y hepaticojejunostomy anatomy, four of whom had undergone liver transplantation for PSC. Technical success was 100%, and stricture resolution was achieved in all three anastomotic-stricture cases. Notably, two of the four PSC patients experienced recurrent cholangitis during follow-up. The authors highlighted that the key advantage of BDS in surgically altered anatomy is the elimination of repeat procedures for stent removal.
Ponsioen et al[25] conducted a multicenter randomized controlled trial that randomized 65 PSC patients to balloon dilation vs short-term stenting; it was terminated early after interim analysis showed equivalent recurrence-free rates (0.34 vs 0.30 at 24 months; P = 1.0) but significantly higher serious adverse events in the stent arm (45% vs 6.7%; odds ratio 11.7; 95%CI: 2.4-57.2; P = 0.001), predominantly PEP and bacterial cholangitis. Current ESGE/European Association for the Study of the Liver and American Association for the Study of Liver Diseases guidelines recommend that if plastic stents are placed in PSC, they should be removed within 1-2 weeks[23,25].
These findings establish a rationale for exploring BDS in PSC. However, no convincing PSC-specific data on BDS safety or efficacy currently exist and, given the established harm of conventional stenting in this population, their use should remain limited to carefully designed research protocols. Overall GRADE certainty for PSC: Very low.
PREVENTION OF REPEAT ENDOSCOPY IN BILIARY LEAKS
Bile-duct injury occurs in approximately 1% of laparoscopic cholecystectomies, with Strasberg A cystic-duct leaks representing the majority of cases[23]. Conventional plastic-stent placement remains the standard endoscopic treatment for postoperative bile leaks but invariably necessitates a second endoscopic procedure for retrieval, exposing patients to additional procedural risk and cost. Biodegradable biliary stents provide temporary ductal patency while obviating subsequent retrieval.
In 2007, Laukkarinen et al[26] conducted one of the earliest prospective animal studies, demonstrating that BDS reduced bile drainage and enabled earlier drain removal compared with conventional plastic stents in post-cholecystectomy cystic-duct leaks, while eliminating retrieval. Siiki et al[23] evaluated 32 patients with Strasberg A cystic-duct leaks over a 3.5-year period, comparing biodegradable PDX stents (n = 8) with conventional plastic stents (n = 24). BDS treatment was safe, with similar readmission and 30-day adverse-event rates. Crucially, all 24 plastic-stent patients required repeat endoscopy for stent removal, whereas none of the 8 BDS patients required a second procedure; median total output was significantly lower with BDS.
Venkatachalapathy et al[27] corroborated these findings in a multicenter prospective study of the ARCHIMEDES stent across six United Kingdom and Irish centers, demonstrating a 17-fold quality-of-life improvement in the bile-leak cohort and a cost saving by eliminating repeat endoscopy. Wu et al[28] reported a case series of four patients who received the ARCHIMEDES stent following laparoscopic choledochotomy; no complications occurred when the stent was correctly positioned and no episodes of pancreatitis occurred, though a learning curve was noted. Mohanka et al[29] reported the ARCHIMEDES absorbable stent placed intraoperatively across duct-to-duct anastomoses in 20 liver-transplant recipients (deceased-donor and living-donor), with no bile leaks, bilomas or stent-related complications; one case of cholangitis from duodenal migration was managed endoscopically.
These liver-transplant findings are reinforced by comparative data. Salamanca-Bustos et al[30] reported the first randomized pilot (n = 10), with 100% patency, no leaks and complete stent resorption in the biodegradable-stent arm. The largest comparative dataset comes from Lopez-Lopez et al[31] (2026; n = 158), in which self-expandable absorbable stents significantly reduced early biliary complications vs no stent (2.6% vs 23.8%; P < 0.001; 0% vs 22.4% after propensity matching), with fewer reinterventions and lower per-patient costs (€6988 vs €36364; P = 0.002).
The broader benign-biliary BDS experience has been synthesized in several systematic reviews. Almeida and Donato[32] found equivalent long-term stricture resolution between BDS and multiple plastic stents (83% vs 84%) but with BDS requiring only one intervention vs three, albeit with higher cholangitis rates (24.1% vs 6.1%). Dreifuss et al[33] pooled 12 studies (384 patients), reporting 100% technical success, 81% clinical success, 3% migration and no mortality. Chen et al[34] reviewed seven percutaneous case series (323 placements) with a technical success of 98%-100%, while Peristeri et al[35] reviewed 15 studies (467 patients), reporting 99.4% technical and 73.3% clinical success, with cholangitis the most frequent adverse event and most reinterventions reflecting planned post-degradation management. These pooled clinical-success figures span the full spectrum of benign biliary disease including strictures, which carry inherently lower success rates whereas bile-leak-specific outcomes are consistently higher across individual studies. Finally, biliary stenting is itself superior to sphincterotomy alone for post-cholecystectomy bile leaks (97% vs 88%; odds ratio 3.91; P < 0.001)[49], reinforcing stenting as the preferred strategy – and BDS eliminate the retrieval burden inherent to conventional stents.
Bile leaks represent a particularly compelling BDS indication: The condition is typically self-limited, healing occurs within the degradation window, and the obligatory second procedure of conventional plastic stents is rendered unnecessary. Overall GRADE certainty for bile leaks: Low-moderate.
LIMITATIONS
This review has several limitations. First, it is a narrative review; although a systematic search strategy was applied, study selection and synthesis were not performed under a pre-registered systematic-review protocol, and formal risk-of-bias scoring of every study was not undertaken. Second, the evidence base is dominated by single-arm cohorts, pilot studies, registries and case series, with few randomized comparisons against conventional stents; sample sizes are small and follow-up is often short, limiting precision and the detection of uncommon adverse events. Third, heterogeneity in stent platforms (PDX vs magnesium alloy), degradation profiles, indications and outcome definitions constrains pooling. Fourth, positive single-centre and industry-associated reports raise the possibility of publication bias. Finally, the health-economic evidence, although now spanning United Kingdom, Australian/New Zealand and Austrian settings, still lacks dedicated cost data from Asian health systems and large multi-country analyses; cost estimates are also sensitive to local procedure tariffs and device pricing.
FUTURE DIRECTIONS
Short term (0-2 years)
Adequately powered randomized controlled trials comparing biodegradable with conventional plastic stents for PEP prophylaxis and benign bile leaks (technical success, PEP incidence, reintervention and cost as co-primary outcomes); prospective registries capturing real-world safety, migration and degradation of newly cleared devices; standardization of outcome definitions and degradation reporting; and embedded health-economic sub-studies with explicit Asian and additional European cost data.
Medium-to-long term (2-5+ years)
Dedicated trials of BDS in high-risk postoperative pancreatic fistula and rigorously designed, safety-focused pilots in PSC dominant strictures; device-engineering studies to match degradation kinetics to healing timelines (e.g., ≥ 3-month support for pancreaticojejunal anastomoses); comparative evaluation of polymer vs magnesium-alloy platforms; and long-term follow-up to establish durability of stricture resolution, late complications and cross-system cost-effectiveness.
CONCLUSION
Biodegradable pancreatobiliary stents represent a meaningful advance in interventional endoscopy, addressing a core limitation of the conventional plastic stent i.e the need for follow-up imaging and repeat endoscopy for retrieval. Across the four indications reviewed, the evidence base varies in maturity but consistently demonstrates clinical feasibility and a favorable safety profile (Table 3).
The case for PEP prophylaxis is most compelling, with prospective, multicenter and cost-effectiveness data across multiple health systems; given that prophylactic stenting remains underutilized largely because of the procedural follow-up burden, BDS may help close this implementation gap. Endoscopically, these stents are easy to deploy, consistent with the high technical success reported across studies (Video 1). For bile leaks, where healing typically occurs within the degradation window, BDS offer a logical strategy to eliminate unnecessary repeat procedures. For postoperative pancreatic fistula and PSC-related strictures, published data remain scarce; encouraging pilot results support continued investigation, but adequately powered randomized trials are needed before routine adoption, and in PSC the established harm of conventional stenting demands rigorous safety evaluation. With United States Food and Drug Administration clearance achieved and adoption growing, the field is positioned for definitive comparative trials that will determine where BDS can transition from a promising innovation to standard of care.
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Footnotes
Peer review: Externally peer reviewed.
Peer-review model: Single blind
Specialty type: Gastroenterology and hepatology
Country of origin: United States
Peer-review report’s classification
Scientific quality: Grade A, Grade A, Grade B
Novelty: Grade A, Grade B, Grade B
Creativity or innovation: Grade A, Grade B, Grade B
Scientific significance: Grade B, Grade B, Grade B
P-Reviewer: Bhinder KK, Research Fellow, United States; Chen HB, Full Professor, MD, Professor, China S-Editor: Luo ML L-Editor: A P-Editor: Lei YY
