Endoscopy 2019; 51(04): S155
DOI: 10.1055/s-0039-1681627
ESGE Days 2019 ePoster podium presentations
Friday, April 5, 2019 14:00 – 14:30: ERCP stenosis ePoster Podium 4
Georg Thieme Verlag KG Stuttgart · New York

FEASIBILITY OF NEW BILIARY AND PANCREATIC BIODEGRADABLE STENT PLACEMENT: INTERIM ANALYSIS OF AN ONGOING SINGLE-CENTER, PROSPECTIVE, PILOT STUDY

A Anderloni
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
A Fugazza
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
L Maroni
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
R Maselli
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
V Ormando
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
F D'Amico
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
S Carrara
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
B Mangiavillano
2   Digestive Endoscopy Unit, Humanitas – Mater Domini Hospital, Castellanza, Varese, Italy
,
PD Omodei
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
P Preatoni
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
L Lamonaca
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
A Cappello
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
G Pellegatta
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
A Repici
1   Humanitas Clinical and Research Center, Rozzano (MI), Italy
› Author Affiliations
Further Information

Publication History

Publication Date:
18 March 2019 (online)

Also available at
 

Aims:

New biliary and pancreatic biodegradable stents (BS) have been developed for endoscopic use. Stents are provided in different sizes and polymeric mixtures allowing 3 expected rates of biodegradation: slow (11 weeks), medium (20 days) and fast (12 days). Aim of the study was to evaluate biodegradation time, safety, technical success of implantation of newly available BS.

Methods:

Interim analysis of ongoing single-center, prospective, pilot study. Patients with indication to biliary or pancreatic plastic stent positioning during ERCP were prospectively enrolled. The primary outcome was the evaluation of biodegradation time, which was controlled by abdominal x-ray (2/4 weeks for fast BS; 3/6 weeks for medium BS; 3/6 months for slow BS). Secondary outcomes were adverse events (AEs) rate according to ASGE lexicon and evaluation of specific stent-related technical features which were arbitrary scored as compared to commonly used plastic stents.

Results:

22 patients (5, 28% female; median age 71,7 years) were enrolled in study (32 BS). Stents were successfully placed in all patients. Stent loadability and pushability were considered good in all cases. Fluoroscopic visualization was good in 85% and medium in 15% of the patients. Evaluation of biodegradation time was available for all fast pancreatic BS and showed partial degradation after 2 weeks and complete degradation after 4 weeks in 4/5 patients, with early migration in one patient. In the remaining treated patients only 6 (2 with medium and 4 with slow BS) showed complete disappearance of the stent at the expected time. No AEs or additional treatments occurred during follow-up period. Only 1 post-ERCP pancreatitis (PEP) was observed in a patient subjected to pancreatic stent placement for PEP prevention after difficult biliary cannulation.

Conclusions:

The results of the interim analysis suggest that BS were feasible, with good fluoroscopic visualization and a favorable profile of safety. Available data of evaluation of biodegradation time suggest that stents survival is in line with expected times.