Long-term lumen-apposing metal stents in endoscopic ultrasound-guided gallbladder drainage: Late adverse events and stent removal

Table 1 Competing strategies for managing the indwelling stent

Dimension	Strategy A: Elective removal after tract maturation	Strategy B: Scheduled exchange for long-term plastic stent	Strategy C: Permanent indwelling LAMS
Target patient profile	Temporarily unfit for surgery; possible future cholecystectomy	Intermediate; needs ongoing drainage but a metal stent is undesirable long term	Definitively inoperable (never a surgical candidate)
Principal rationale	Preempts late stent-specific events; often combined with cholecystoscopic stone clearance	Maintains a low-profile conduit through an established tract	Avoids repeat instrumentation in frail patients
Supporting evidence	Kamata et al[58] (self-expandable metal stent, not LAMS): Removal at about 4 weeks with no migration or impaction; Choi et al[59] and Walter et al[60]: Long-term outcomes after removal or exchange	Commentary recommendation for patients with extended life expectancy[44]; DRAC-1 protocol[27]; no dedicated trial	Yuste et al[43]; recurrence not increased by retention[36]; most patients die with the stent in situ[44]
Principal risk traded	Recurrent cholecystitis if the cystic duct is obstructed and no conduit is left	Requires repeat endoscopy; uncertain durability	An indefinite, albeit low, risk of burial, erosion, and impaction; it may also complicate subsequent surgery[62,63]
Evidence quality1	Low	Very low	Low to moderate
Basis for the grading	Small single-center series, one using a self-expandable metal stent rather than a LAMS; indirectness of the population; no comparator[58,59]	No study reports the strategy as an intervention; entirely inferential from protocol descriptions and expert opinion[27,44]	Two or more retrospective single-center and multicenter cohorts with follow-up beyond 1 year but serious risk-of-bias from competing mortality and short median follow-up[36,43,44]
Outstanding question	Optimal timing of removal is undefined	Whether exchange outperforms retention	Whether the apparent safety of permanence is real or an artifact of short survival

¹Grading was assigned by the authors using an approach adapted from the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) and applied to the body of evidence supporting each strategy, as described in the section “How the evidence was identified”. Low to moderate = two or more cohorts with follow-up beyond 1 year but serious risk-of-bias; Low = single small series or indirect population; Very low = no study reports the strategy as an intervention. No formal GRADE assessment was performed, and no strategy is supported by randomized data. A higher grade reflects the quantity and design of the available evidence and not a stronger recommendation. DRAC-1: Randomized trial of endoscopic ultrasound-guided vs percutaneous gallbladder drainage; LAMS: Lumen-apposing metal stent.

Table 2 Representative studies and pooled analyses of endoscopic ultrasound-guided gallbladder drainage with lumen-apposing metal stents

Ref.	Design and patients	Technical success	Clinical success	Follow-up	Key long-term findings
Teoh et al[27], 2020	Randomized trial vs PTGBD; 80 patients recruited (39 EUS-GBD, 41 PTGBD); 39 vs 40 analyzed	97.4%	92.3%	1 year	1-year adverse event rates were 10/39 (25.6%) vs 31/40 (77.5%)b for PTGBD; recurrent cholecystitis 1/39 (2.6%) vs 8/40 (20%); reintervention beyond 30 days 1/39 (2.6%) vs 12/40 (30%)
Binda et al[21], 2024	Multicenter cohort; 116 patients; mean age 82.7 years	94%	87.1%	Mean 309 days	Adverse events in 12/116 (10.3%); 8 intraprocedural, 1 early, 3 late; no fatal adverse events; no recurrence among 40 patients followed beyond 1 year
Dollhopf et al[35], 2017	Multicenter cohort; 75 patients; electrocautery-enhanced LAMS	98.7%	95.9%	Not reported as a single value	Overall adverse events 8/75 (10.7%); late events in 6 patients: Recurrent cholecystitis (3), migration (2), Bouveret syndrome (1); all managed without surgery
David et al[36], 2025	Multicenter cohort; 109 patients; 18 United States centers	99.1% (108/109)	Initial 97.2% (106/109); long-term 89.9% (98/109)	Median 140 days (IQR 76-330; range 30-1188)	Events beyond 30 days in 10/109 (9.2%), of which 7/109 (6.4%) were LAMS-specific; LAMSs removed in 24/109 (22%); recurrent cholecystitis 1/24 (4.2%) after removal vs 7/85 (8.2%) after retention, with no statistically significant difference; the decline from initial to long-term clinical success and the short median follow-up limit long-term inferences
Yuste et al[43], 2019	Single-center series; 22 of 47 patients with dwell time > 1 year	NR1	NR1	Median 24.4 months (IQR 18.2-42.4)	No stent-related events beyond 12 months; 1 patient (4.5%) readmitted for gallstone-related disease; one completely buried stent at 61.5 months with patent fistula
Martinez-Moreno et al[44], 2023	Single-center registry; 50 patients analyzed; 3-year design	91.2% (62/68)2	98% (49/50)	Median 25.0 months	Adverse events in 18%, 20%, and 26% of patients during years 1-3; 14 LAMS-related events in 11 patients (22%) at a median of 674 days; only 5/14 (35.7%) symptomatic, and late events increasingly asymptomatic; all 7 migrations (14%) asymptomatic; symptomatic events accounted for 66.7% of events associated with a transgastric stent vs 12.5% of those from a transduodenal stenta; recurrent cholecystitis 2/50 (4%); no stent-related bleeding or stent-related death
Fabbri et al[34], 2022	Proportion meta-analysis; 27 studies; 1004 patients	98.0% (95%CI: 96.3-99.3)	95.4% (95%CI: 92.8-97.5)	Varied across studies	Pooled procedure-related adverse event rate was 14.8%; meta-regression identified institutional volume and stent type as outcome modifiers
Canakis et al[45], 2026	Meta-analysis restricted to follow-up ≥ 1 year; 18 studies; 701 patients	95.8% (95%CI: 93.9-97.2)	94.3% (95%CI: 92-96)	≥ 1 year by design	Recurrent cholecystitis rate at or beyond 1 year was 4.2%; 1-year readmission rate was 19%; reintervention rate 6%; repeat endoscopy due to occlusion 2.9%; mean patency 418.8 days (I2 = 98%); approximately half the patients did not receive a LAMS

^aP < 0.05, transgastric vs transduodenal stent position.

^bP < 0.01, endoscopic ultrasound-guided gallbladder drainage vs percutaneous transhepatic gallbladder drainage.

¹The series was restricted to the 22 of 47 patients whose stent remained in situ for more than 12 months; procedural success was therefore not an endpoint and is not reported.

²Denominator is the 68 patients assessed for gallbladder drainage; of the 62 technically successful procedures, 12 were performed for indications other than acute cholecystitis and were excluded, leaving 50 patients for analysis.

EUS-GBD: Endoscopic ultrasound-guided gallbladder drainage; IQR: Interquartile range; LAMS: Lumen-apposing metal stent; NR: Not reported; PTGBD: Percutaneous transhepatic gallbladder drainage.

Table 3 Late adverse events of indwelling lumen-apposing metal stents organized by mechanism

Mechanism	Affected domain	Specific events	Typical timing	Evidence and source
Luminal	Channel patency and drainage	Food impaction; sludge- or stone-related occlusion; recurrent cholecystitis	Accumulates with longer dwell time	Drives recurrent cholecystitis and provides the rationale for coaxial pigtail placement and proactive cholecystoscopy[9,55]; recurrent cholecystitis in 3 of 75 patients[35], in 2 of 55 patients[50] and in 2 of 50 patients[44]; no significant difference by removal status[36]; pooled recurrence beyond 1 year 4.2%[45]
Mural	Stent-wall interaction	Tissue overgrowth; buried LAMS syndrome; delayed bleeding from flange erosion	More apparent with longer dwell time	Mechanistically expected and informed by a dedicated adverse-event meta-analysis[46]; no cohort reports incidence as a primary endpoint; a completely buried stent was documented at 61.5 months[43]; a device with a lower apposing force showed a low rate of buried stent syndrome[23]
Mechanical	Loss of apposition	Migration into the gallbladder lumen or distal migration	Early or late	Migration in 2 of 75 patients[35] and in 7 of 50 patients (14%) in a 3-year registry, in which every migration was asymptomatic[44]; frequently asymptomatic when the stent migrates internally

Rates given are single-study figures unless labeled as pooled. Symptomatic late events cluster in the first year, whereas asymptomatic tissue overgrowth and migration continue to accumulate thereafter[43,44]. Every value in this table is a crude proportion derived from a cohort with high competing mortality and limited observation, and therefore describes that cohort rather than a risk transferable to an individual patient. LAMS: Lumen-apposing metal stent.