USEFULNESS AND SAFETY OF A NEW DIGITAL SINGLE-OPERATOR CHOLANGIOSCOPY: A SINGLE-CENTER EXPERIENCE

Aims A new DSOC system called Eye-Max^TM (Micro-Tech, Nanjing, China) has been developed with a 9Fr and 11Fr scopes and full HD+image (150000 pixels). We aimed to report diagnostic accuracy, biliary stone clearance, and procedure-related adverse events with this new device.

Methods Prospective data was collected in consecutive patients aged≥18 years referred for DSOC between July-November 2021. Suspected malignancy/indeterminate stricture diagnosis were allocated into the diagnostic group; failed lithotripsy or>20mm biliary stones were allocated into the therapeutic group. Patients with<6-month follow-up, uncontrolled coagulopathy, pregnant/lactating, with contrast allergy or with no scope passage, were excluded. The institutional review board approved the study protocol, and the study was conducted according to the Declaration of Helsinki. All patients provided written informed consent. Data was analyzed in Rv.4.0.

Results 31 cases were attended. In the diagnostic cohort (n=21/31; 68%), neoplastic signs at visual impression were identified in 10/21 (47.6%) cases using in 8/10 a 9Fr scope. Biopsy was performed in 14/21 (66.7%) cases and confirmed neoplasia in 10/21 (47.6%). DSOC achieved an accuracy for neoplastic diagnosis with a 90% sensitivity, 75% specificity ([Table 1]). In the therapeutic cohort (12/31; 39%): 11/12 cases required lithotripsy, being 1/12 a pancreatoscopy, and 1/12 underwent DSOC due to proximal biliary stent migration. Complete stone clearance was achieved in 10/11 (91%) patients (Fig. 1). No periprocedural or late adverse events were documented.

Table 1 Diagnostic cohort (21/31; 68 %).

	Total (N=21)
Age (years), median (IQR)	59.0 (46.0 – 66.0)
Indication, n (%)
Biliary tract lesion	20 (95.2)
Pancreatic duct stricture	1 (4.8)
Adecuate biopsy, n(%)	14 (100.0)
Histopathological diagnosis (n=14), n (%)
Inflammatory	3 (21.4)
Cholangiocarcinoma	9 (64.3)
Secondary to malignant infiltration	1 (7.1)
IgG4	1 (7.1)

Fig. 1

Conclusions Eye-Max^TM DSOC has excellent diagnostic efficacy for distinguishing neoplastic biliary lesions, as well as therapeutic profitability.

Publikationsverlauf

Artikel online veröffentlicht:
14. April 2022