PURPOSE: The,safety and efficacy of ablating gallbladder mucosa was in
vestigated with a percutaneously placed heater catheter in animal stud
y. MATERIALS AND METHODS: The study was performed in three stages with
39 pigs. In stage 1 (15 heat-treated animals, one control), the confi
guration of the heater catheter was progressively improve and the temp
erature settings for stage 2 were defined. In stage 2 (11 heat-treated
animals, four controls), the predetermined settings we used with mech
anical mixing and cystic duct ligation to test for safety and efficacy
. In stage 3 (eight animals), prior heat ablation of the cystic duct w
as added to reduce epithelial regeneration. RESULTS: Gallbladder ablat
ion was achieved at temperatures below 60-degrees-C. Mechanical mixing
of the intraluminal contents was essential for even heat distribution
for ablation and to reduce the incidence of adjacent organ damage. Th
ermal injury to adjacent organs occurred when gallbladder ablation tem
perature exceeded 54-degrees-C and serosal temperatures of adjacent or
gans exceeded 43-degrees-C. Thermal ablation at 54-degrees-C for 35 mi
nutes was completely successful in 25%, partially successful in 50%, a
nd failed in 25% of animals. Cystic duct ablation improved overall res
ults and appears vital in removing duct epithelium as a source for reg
eneration of the mucosal lining. CONCLUSION: Defunctionalization of th
e retained gallbladder is potentially achievable with use of thermal t
echniques, but the thermal range between complete gallbladder ablation
and adjacent organ injury is narrow.