The use of a 532-nm laser fitted with a balloon and a cylindrical light diffuser to treat benign biliary stricture: a pilot study

Abstract

Endoscopic management of benign biliary stricture (BBS) remains challenging. Stenting is currently used for BBS management, but refractory BBS remains problematic. The aim of this study was to assess the safety and feasibility of a dilation balloon-equipped cylindrical light diffuser for BBS in a large animal model. A total of seven mini-pigs were used in the current study. Laser settings were chosen based on the findings of a previous animal study. Five animals were used in a preliminary study to establish process conditions. BBSs were created in the common bile ducts of the other two animals by intraductal radiofrequency ablation (RFA) via endoscopic retrograde cholangiography (ERC). At 4weeks post-RFA, laser ablation was performed using a customized balloon-equipped cylindrical diffuser at 10W for 10s while maintaining balloon inflation for 10s at 5atm. A follow-up ERC was performed at 4weeks post-laser ablation and the animals were sacrificed for histologic evaluation. BBS was observed in all animals by ERC at 4weeks post-RFA. The mean bile duct stricture diameter in the two animals as determined by ERC was 0.8mm. Laser ablations were performed without technical difficulty and no adverse event was encountered. At 4weeks post-laser ablation, mean biliary stricture diameter had dilated to 1.6mm on cholangiographic finding. On histologic examination, inflammatory cell infiltration in lamina propria and dense collagen deposition were observed, but there was no evidence of bile duct perforation. The devised balloon-equipped cylindrical laser light diffuser appears to be safe and feasible for the treatment of BBS. However, further studies and modifications are required before it can be applied clinically as a monotherapy.