Feasibility of a novel system for intraductal balloon-anchored direct peroral cholangioscopy and endotherapy with an ultraslim endoscope (with videos).

Background: Advantages of direct peroral cholangioscopy (DPOCS) by using an ultraslim endoscope include a single-operator platform, image quality equal to that of standard endoscopy, and separate water and air channels. However, DPOCS has significant limitations, including cumbersome biliary access, en-face position with the ampulla, and gastric looping of the endoscope. A newly designed anchoring balloon may overcome these challenges.

Objective: To report the feasibility of DPOCS with the anchoring balloon.

Design: Pilot study, porcine model.

Setting: Animal resources center.

Intervention: The anchoring balloon system developed by Cook Medical (Winston-Salem, NC) was used for DPOCS.

Main Outcome Measurements: Primary: Feasibility of biliary access maintenance and intraductal mobility. Secondary: Feasibility of intraductal therapeutic procedures.

Results: Four animal subjects underwent DPOCS with the anchoring balloon. Ductal access was achieved with sphincterotomy in 2 subjects and with a balloon sphincteroplasty in 2 subjects. Intraductal placement of the ultraslim endoscope was achieved in all biliary access attempts without balloon migration or deflation. Common bile duct, cystic duct, bifurcation, and main right and left duct direct visualization was achieved in all cases. Therapeutic interventions by DPOCS, including intraductal biopsy, balloon dilatation, and intraductal bilateral metal stent placement, were all completed successfully. Biliary perforation occurred in one case because of balloon overinflation and in a second case because of sphincterotomy.

Limitations: Prototype study in an animal model and small study size.

Conclusion: Our results show that the novel anchoring balloon system successfully and safely enables DPOCS for both diagnostic and therapeutic interventions. If corroborated in human trials, it could offer a new platform for biliary interventions.