Preventive role of biodegradable pancreatobiliary stents

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.