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CC BY-NC-ND 4.0 · Endosc Int Open
DOI: 10.1055/a-2366-2265
Original article

Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy

Ivo Boskoski 
1   Digestive Endoscopy Unit, Fondazione Policlinico Gemelli, Rome, Italy
2   Service de Chirurgie Digestive et Endocrinienne, IHU Strasbourg - Institut hospitalo-universitaire de Strasbourg, Strasbourg, France
,
Torsten Beyna
3   Department of Internal Medicine, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany
,
James YW Lau
4   Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong
,
Arnaud Lemmers 
5   Gastroenterology and Hepatology, Hôpital Erasme, Bruxelles, Belgium (Ringgold ID: RIN70496)
,
Mehran Fotoohi
6   Radiology, Virginia Mason Medical Center, Seattle, United States (Ringgold ID: RIN7289)
,
Mohan Ramchandani
7   Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
,
Valerio Pontecorvi
8   Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy (Ringgold ID: RIN18654)
,
Joyce Peetermans
9   Endoscopy, Boston Scientific Corporation, Marlborough, United States
,
Eran Shlomovitz
10   Department of Surgery, Toronto General Hospital, Toronto, Canada (Ringgold ID: RIN33540)
› Author AffiliationsSupported by: Boston Scientific Corporation N/A

Clinical Trial: Registration number (trial ID): NCT04580940, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective, multicenter, multinational case series
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BACKGROUND & AIMS Percutaneous transhepatic cholangioscopy (PTCS) is a management option for patients who fail per-oral cholangioscopy or ERCP. We conducted a case series on the efficacy and safety of PTCS using a cholangiopancreatoscope cleared by the FDA in 2020. METHODS Fifty adult patients scheduled for PTCS or other cholangioscopic procedure were enrolled at seven academic medical centers and followed for 30 days after the index procedure. The primary efficacy endpoint was achievement of clinical intent by 30 days after the index PTCS procedure. Secondary endpoints included technical success, procedural time, endoscopist ratings of device attributes on a scale of 1 to 10 (best), and serious adverse events (SAEs) related to the device or procedure. RESULTS Patients had a mean age of 64.7±15.9 years, and 60.0% (30/50) were male. Forty-four (88.0%) patients achieved clinical intent by 30 days post-procedure. The most common reasons for the percutaneous approach were past (38.0%) or anticipated (30.0%) failed ERCP. The technical success rate was 96.0% (48/50), with a mean procedural time of 37.6 (SD, 25.1; range 5.0–125.0) minutes. The endoscopist rated the overall ability of the cholangioscope to complete the procedure as a mean 9.2 (SD, 1.6; range 1.0–10.0). Two patients (4.0%) experienced related SAEs, one of whom had a fatal periprocedural aspiration. CONCLUSIONS PTCS is an important endoscopic option for selected patients with impossible retrograde access or who fail ERCP. Because of the associated risk, this technique should be practiced by highly trained endoscopists at high-volume centers. (ClinicalTrials.gov number, NCT04580940)



Publication History

Received: 30 January 2024

Accepted after revision: 10 July 2024

Accepted Manuscript online:
15 July 2024

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