A NEW BIODEGRADABLE STENT IN BILIO-PANCREATIC DISEASES: A PROSPECTIVE MULTI-CENTER FEASIBILITY STUDY

Aims Biodegradable stents of various designs are reportedly used in pancreato-biliary conditions with promising results. Their major advantage is the avoidance of a repeat endoscopic procedure for stent removal thereby reducing overall cost along with ERCP associated adverse events. To evaluate the feasibility and safety of a new biodegradable stent in patients with pancreato-biliary diseases.

Methods Prospective multicenter pilot study. All consecutive patients ³18 years-old who underwent biliary or pancreatic stenting using the new biodegradable Archimedes stent were included. There were three biodegradation profiles. Technical and clinical success, feasibility and safety were assessed during a pre-established follow-up schedule.

Results Fifty-three patients (mean age: 48.54±19.29, 66% male) having biliary (n=29, 54.7%%) or pancreatic (n=24, 45.3%) indications were included. The distribution of stents used according to degradation properties were as follows: fast (n=11, 20.8%), medium (n=16, 30.2%) and slow (n=26, 49.1%). The technical and clinical success were 100% and 77.8%. Thirty-five patients were followed for a median of 26 weeks (range: 4-56, 66%). There were 9 procedure-related adverse events (17%), all mild, including one uneventful stent-related event (external migration).

Table 1 Procedural performances of the new biodegradable Archimedes stent for biliary and pancreatic indications using a predesigned 4-points score (1-excellent, 2-good, 3-fair, 4-poor) grouped in high (1-2) or low (3-4).

	Loadability	Pushability	Flexibility	Fluoroscopic visualization	Deployment accuracy
Overall (score)	Excellent (n=43, 81.1%) Good (n=9, 17%) Fair (0) Poor (n=1, 1.9%)	Excellent (n=45, 84.9%) Good (n=4, 7.5%) Fair (n=2, 3.8%) Poor (n=2, 3.8%)	Excellent (n=32, 60.4%) Good (n=16, 30.2%) Fair (n=3, 5.7%) Poor (n=2, 3.8%)	Excellent (n=30, 56.6%) Good (n=18, 34%) Fair (n=5, 9.4%) Poor (0)	Excellent (n=41, 77.4%) Good (n=10, 18.9%) Fair (n=2, 3.8%) Poor (0)
Biliary indications	High (n=28, 96.6%) Low (n=1, 3.4%)	High (n=25, 86.2%) Low (n=4, 13.8%)	High (n=24, 82.8%) Low (n=5, 17.2%)	High (n=27, 93.1%) Low (n=2, 6.9%)	High (n 27, 93.1%) Low (n=2, 6.9%)
Pancreatic indications*	High (n=24, 100%) Low (0)	High (n=24, 100%) Low (0)	High (n=24, 100%) Low (0)	High (n=21, 87.5%) Low (n=3, 12.5%)	High (n=24, 100%) Low (0)

Fig. 1

Conclusions The biodegradable Archimedes stent placement is feasible and safe in pancreato-biliary diseases.

Publication History

Article published online:
14 April 2022