Preventive role of biodegradable pancreatobiliary stents

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
UNITY-B	Balloon-expandable magnesium alloy, polymer-coated	8-10 mm	Manufacturer range	Approximately 1-6 months	CE-marked (Europe); investigational in United States	Benign biliary strictures
PDX biliary stent (e.g., SX-ELLA-BD)1	PDX monofilament, self-expanding	Approximately 8-10 mm	30-80 mm	approximately 6 months to full resorption	CE-marked (Europe)	Benign biliary strictures; percutaneous and endoscopic use

¹Row-three parameters are indicative; confirm against the current manufacturer instructions-for-use before publication.

Degradation times are approximate and not directly comparable across platforms; reported values may reflect loss of mechanical strength, loss of structural integrity, or complete bioresorption. In-vivo degradation varies with polymer composition, device dimensions, ductal-fluid pH, infection and implantation site. Regulatory authorization and commercial availability vary by jurisdiction. BPS: Biodegradable pancreatobiliary stent; PDX: Polydioxanone; CE: Conformité Européenne; FDA: United States Food and Drug Administration; Fr: French gauge; PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis.

Table 2 Summary of existing clinical studies across the four major indications

Ref.	Design	n	Stent type	Key results	Notes
PEP prophylaxis
Anderloni et al[10], 2020	Prospective pilot	38 (9 for PEP)	ARCHIMEDES	100% technical success	1 mild PEP; no cholangitis
Pérez-Cuadrado Robles et al[15], 2022	Prospective multicenter feasibility	53	ARCHIMEDES	100% technical; 77.9% clinical success	All AEs mild
Maieron et al[16], 2023	Observational multicenter (Austria)	60 patients/63 stents	Biodegradable	94% technical; 90% clinical; no follow-up in 97%	2 reinterventions
McGarrigle et al[14], 2026	Retrospective multicenter (Australia and New Zealand)	111 ERCPs	Biodegradable pancreatic	98% technical; PEP 11% (all mild); AUD $393/patient saving	Preferred by 75% of endoscopists
Abbasi et al[17], 2026	Health-economic model (United Kingdom NHS)	Model-based	Biodegradable pancreatic	Cost-effective; ICER approximately £9317/QALY	Model-based
POPF
Bakheet et al[19], 2020	Preclinical (porcine)	Animal	Tubular BDS	Reduced PJ anastomotic stricture	Preclinical
Mazzola et al[18], 2022	Prospective technical series	High-risk PJ	Internal BDS	CR-POPF 13.3%	No significant stent-related complications
González-Abós et al[21], 2025	Propensity-matched cohort	80 high-risk	Biodegradable	0% POPF vs 10%; P = 0.039	Consistent matched/unmatched
Farooqui et al[20], 2025	Systematic review and meta-analysis	8 studies/155	Biodegradable	Pooled POPF approximately 7%	Observational only
Farooqui et al[22], 2026	Blinded RCT (interim)	50 of 310 planned	ARCHIMEDES (fast)	CR-POPF 11.5% vs 25.0% (P = 0.20); biochemical leak 0% vs 12.5% (P = 0.01)	Comparable major complications/mortality
PSC/altered anatomy
Ponsioen et al[25], 2018	Multicenter RCT (balloon vs plastic)	65	Plastic (comparator)	Equivalent recurrence; higher AEs with stenting (45% vs 6.7%)	Harm of conventional stenting in PSC
Lindström et al[24], 2020	Case series (DBE)	7 (4 PSC)	ARCHIMEDES	100% technical; resolution 3/3 anastomotic	2/4 PSC recurrent cholangitis
Bile leaks
Laukkarinen et al[26], 2007	Prospective animal study	Animal	Biodegradable biliary	Reduced drainage; earlier drain removal; no retrieval	Preclinical
Siiki et al[23], 2018	Comparative cohort (3.5 years)	32 (8 vs 24)	PDX	No repeat endoscopy in BDS; lower total output	Similar 30-day AEs
Mohanka et al[29], 2021	Prospective series (liver transplant)	20	ARCHIMEDES	No bile leaks/bilomas/stent-related complications	1 cholangitis (migration)
Salamanca-Bustos et al[30], 2016	Randomized pilot (LT)	10	Biodegradable	100% patency; no leaks; complete resorption	First RCT pilot
Lopez-Lopez et al[31], 2026	Comparative cohort (LT)	158	Self-expandable absorbable	Early biliary complications 2.6% vs 23.8% (P < 0.001); cost €6988 vs €36364	Propensity-matched
Wu et al[28], 2025	Case series (post-choledochotomy)	4	ARCHIMEDES	No complications when positioned; no pancreatitis	Learning curve
Venkatachalapathy et al[27], 2025	Prospective multicenter (United Kingdom/Ireland)	Cohort	ARCHIMEDES	17-fold QoL improvement; cost saving	Observational
Cross-cutting
Chen et al[34], 2025	Systematic review (percutaneous)	7 studies/323	Biodegradable biliary	Technical success 98%-100%	Hemobilia most frequent
Peristeri et al[35], 2026	Systematic review (PRISMA)	15 studies/467	Biodegradable (mostly PDX)	Technical 99.4%; clinical 73.3%	Cholangitis most frequent; reintervention mostly planned
Almeida and Donato[32], 2020	Systematic review and meta-analysis	Benign strictures	BDS vs multiple plastic	Resolution 83% vs 84%; 1 vs 3 interventions	Cholangitis 24.1% vs 6.1%
Dreifuss et al[33], 2025	Systematic review and meta-analysis	12 studies/384	Absorbable biliary	100% technical; 81% clinical; 3% migration	No mortality

Study design, sample size, primary outcome(s) and adverse events for the studies underpinning each indication. Nagra et al[49] is comparator context (biliary stenting vs sphincterotomy) – none are biodegradable-stent studies. Ponsioen et al[25] is listed as comparator context (a conventional plastic-stent randomized controlled trial demonstrating the harm of stenting in primary sclerosing cholangitis). Almeida and Donato[32], Dreifuss et al[33], Chen et al[34], and Peristeri et al[35] are cross-cutting systematic reviews. AUD: Australian dollars; BDS: Biodegradable stents; CR-POPF: Clinically relevant postoperative pancreatic fistula; DBE: Double-balloon enteroscopy; ERCP: Endoscopic retrograde cholangiopancreatography; ICER: Incremental cost-effectiveness ratio; LT: Liver transplantation; PDX: Polydioxanone; PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis; PJ: Pancreaticojejunostomy; POPF: Postoperative pancreatic fistula; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PSC: Primary sclerosing cholangitis; QALY: Quality-adjusted life-year; QoL: Quality of life; RCT: Randomized controlled trial; AEs: Adverse events.

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

Grading of Recommendations Assessment, Development and Evaluation certainty is assigned to a specific outcome, not to a study or indication as a whole. For post-endoscopic retrograde cholangiopancreatography pancreatitis prophylaxis, two outcomes are shown: (1) Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis; and (2) Itself (very low) and avoidance of follow-up imaging and endoscopic retrieval (moderate). Animal evidence was treated as supportive and indirect and was not used to determine clinical certainty. Where certainty is already very low on the basis of risk of bias, indirectness and imprecision, suspected publication bias is documented as a concern but is not the determining factor; with fewer than approximately ten studies per outcome it could not be formally tested. Grading of Recommendations Assessment, Development and Evaluation uses four discrete categories: (1) High; (2) Moderate; (3) Low; and (4) Very low. PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis; POPF: Postoperative pancreatic fistula; PSC: Primary sclerosing cholangitis; PD: Pancreaticoduodenectomy.