Background and objectives:

Pancreatitis and cholecystitis are major complications following stenting with covered metallic stents to manage malignant distal biliary obstructions. We compare the use of a conventional covered biliary stent with a new prototype of a covered biliary stent with a flower-pedal structure that uses with low axial force and radial force in order to evaluate impacts on cholecystitis and pancreatitis after stenting.

Methods:

This is a non-randomized prospective comparison of a group of 18 patients stented with a flower-like biliary stent (FS group) with a group of 36 patients who received conventional biliary stents (CS group) ratio for management of malignant distal biliary obstructions. Demographic data and data about technical and clinical success including the appearance of cholecystitis and/or pancreatitis, migration rates and/or occlusion were evaluated.

Results:

The 18 FS group patients included 7 men (39%) and had a median age of 72 years. The 36 CS group patients included 16 men (44%) and had a median age of 71 years. There were three cases of cholecystitis and four cases of pancreatitis, all of which were in the CS group. Multivariate analysis showed statistically significant differences between the two groups in four clinical areas: hemoglobin, length of stenosis, etiology and occlusion of stents. No significant differences were found in survival time functions (Log Rank, p = 0.399). In Cox’s proportional hazards model, the only significant difference with respect to survival times was found on the issue of whether or not metastasis was present.

Conclusions:

The use of the new prototype flower-like biliary stent with lateral grooves and lower axial force and radial force is related to a lower rate of complications such as cholecystitis and pancreatitis than the use of conventional stents for palliation of distal malignant biliary stenoses. The new stent has no detriments in terms of permeability or migration and did not affect the survival of these patients.

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