Clinical evaluation of a prototype multi-bending peroral direct cholangioscope

Abstract

Background: Although peroral direct cholangioscopy (PDCS) is emerging as an alternative to traditional mother-daughter cholangioscopy, it is associated with high failure rates. The aim of the present study was to evaluate the ability to insert and carry out interventions using a prototype multi-bending PDCS.

Patients and methods: Prospective, observational clinical feasibility study was done in 41 patients with a variety of biliary diseases. A multi-bending PDCS prototype was inserted using a free-hand technique, a guidewire alone, or with a 5-Fr diameter anchoring balloon. Diagnostic and therapeutic procedures were carried out.

Results: The free-hand direct insertion technique failed in all attempted cases (n = 7). Of the remaining 34 cases, successful rate of PDCS insertion into the distal bile duct was achieved by passing the PDCS over a guidewire alone (n = 6) and/or with a guidewire plus anchoring balloon (n = 28) for an overall successrate of 88.2% (30/34). In 13 (92.9%) patients without an underlying biliary stricture, PDCS insertion proximal to the bifurcation was possible. In 25 cases, biliary interventions were attempted including biopsy (n = 13), stone removal (n = 6), stent removal (n = 1), and intraductal electrohydraulic lithotripsy (n = 2) and were successful in 22 (88%). Other than two patients with procedure-related cholangitis with a mild grade of severity, no complications were observed.

Conclusions: Using a novel multi-bending prototype peroral direct cholangioscope, cholangioscopy had a high diagnostic and therapeutic success rate only when passed over a guidewire and anchoring balloon but not with the free-hand insertion technique. Comparative studies of direct cholangioscopy are warranted.

Keywords: endoscopic retrograde cholangiopancreatography (ERCP); peroral direct cholangioscopy.

Figure 1

Second-generation prototype direct peroral cholangioscope. (a) The outer diameters of the distal end and the insertion tube are 5.2 mm (15-cm tip length) and 7.0 mm, respectively. It has two accessory channels. (b) This prototype has two bending sections: the proximal section can be deflected in a single plane (90° up and 90° down), and the distal section can also be deflected in a single plane (160° up and 100° down).

Figure 2

Prototype endoscope inserted into the distal bile duct.

Figure 3

(a) Prototype endoscope was inserted into the left intrahepatic bile duct. (b) Subtle papillary lesions (arrows) were detected in a patient with biliary intraductal papillary neoplasm.

Figure 4

Endoscopic direct lithotripsy. (a) X-ray shows grasping a stone using a basket catheter with the prototype cholangioscope. (b) Endoscopic image shows grasping of the stone with a basket.

Figure 5

Retrieval of a migrated plastic stent using a basket catheter with the prototype cholangioscope. (a) X-ray image. (b) Endoscopic image.