Cholecystectomy results in bile duct damage in 3000 patients annually. To avoid these devastating injuries, the investigators propose an endoluminal operation using three technical innovations: 1) a cannula that attaches to the gallbladder surface, 2) a rapid rotary lithotriptor, and 3) a self-expanding cystic duct plug. After applying the above, the investigators propose to destroy the mucosa using photodynamic therapy (PDT). Devoid of mucosa, the gallbladder walls will scar together and obliterate the lumen. Sclerosing agents failed to reach the Rokitansky-Ascholl (RA) sinuses in prior human ablation trials. In our studies with ex vivo human gallbladders, a photosensitizer did penetrate the RA sinuses. Now the investigators propose ablating abnormal mucosa. First they will establish a model for inflammation and RA sinuses by studying gallbladder morphology at 4, 8, and 12 weeks in rabbits fed a lithogenic diet of chow with added dihydrocholesterol (N15). Second, they will determine the doses of drug and light required to ablate this mucosa (N40). In phase II, the investigators will treat pigs and conduct safety studies requisite for a Phase I clinical trial. The devices have considerable commercial potential. This study could set in motion a single-puncture, regional-anesthesia, outpatient procedure that completely eliminates bile duct injuries.
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