Contribution of the new Eyemax (Microtech) cholangioscope: A multicenter pilot study on the first French experiences

Aims Cholangioscopy has advanced biliary stricture diagnosis, but challenges persist in collecting quality samples due to the limited working channel. A new cholangioscope with a 2.0 mm working channel (Eyemax, Microtech France), which accommodates pediatric forceps (1.6mm), is now available in France. This study gathered initial French experiences from five centers where the device was deployed.

Methods A retrospective multicenter observational study on cholangioscopies conducted between February and October 2024 across five endoscopy units within the CREGG (French Private Gastroenterology Corporation). Collected data included patient demographics, investigator satisfaction surveys, follow-up details, and histopathology results. Overall satisfaction and cholangioscopy step evaluations were recorded using a visual analog scale (VAS) and compared to the commonly used Spyglass cholangioscope (Boston Scientific). Inter-observer agreement was determined with the use of absolute percentages of agreement and unweighted Fleiss's kappa values. Interpretation of Fleiss's kappa values was made according to Landis and Koch.

Results The study included 27 patients (15 men, 12 women, mean age 71.85±10.69), with prior endoscopic sphincterotomy in 70%. The procedure was performed during a scheduled anticoagulation therapy interruption for 2 patients (7.4%) and under antiplatelet therapy for 5 patients (18.5%). Indications were biliary strictures in 96.3% and lithotripsy in 3.7%. Strictures involved the bile duct in 41% and the hilum in 59% (Bismuth classifications: 18.2% Bismuth 1, 13.6% Bismuth 2, 18.1% Bismuth 3, and 9.1% Bismuth 4).

The mean satisfaction score was 8.66 (SD 1.06), with 85% rating Eyemax as better, 11.1% as equivalent, and 3.7% as worse than Spyglass. Inter-observer agreement was slight (Κ=0.1; CI[0.053; 0.15]). The mean number of biopsies was 8.46 (SD 2.92), averaging 12.85 minutes (SD 5.62) with a 100% success rate. Pathology material was rated as rich in 30%, adequate in 55%, and low in 15%.

Cholangiocarcinoma was diagnosed in 13 of 15 cases (86.7% sensitivity), and benign strictures in 8 cases, all of which regressed. Three patients with negative biopsies remain under follow-up to confirm stricture nature. Procedure-related pain was noted in 7.4% of cases, fever in 3.7%, an infectious complication in 3.7%, and acute pancreatitis in 7.4% (including one severe case requiring a 15-day hospital stay).

Conclusions This pilot study on the first French uses of the Eyemax cholangioscope underscores its ease of use and high satisfaction, particularly in facilitating biopsies, which are very easy to perform and with an 86.7% sensitivity in cholangiocarcinoma diagnosis (pending final confirmation in ongoing cases).

 

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Conflicts of Interest

Adrien Sportes, MD: Consultant for OLYMPUSDavid Karsenti, MD: Consultant for OLYMPUS, NORGINE and COVIDIEN, Support for attending meetings from ALFASIGMA, COOK and FUJIFILMSarah Leblanc, MD: Consultant for OLYMPUS, BOSTON, NORGINE, Support for attending meetings from FUJIFILMBertrand Brieau, MD: Consultant for Boston scientific, Support for attending meetings from ALFASIGMA, and FUJIFILMIsaac Fassler, MD: Support for attending meetings from ALFASIGMA

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Artikel online veröffentlicht:
27. März 2025