Evidence map›Paper›PMID 40808865›Full record

ArticleTherapeutic advances in gastroenterology2025

Contribution of the EyeMAX™ 11Fr (Micro-Tech) digital single-operator cholangioscope with a wide working channel: a multicenter pilot study on the first French experiences.

David Karsenti, Adrien Sportes, Sarah Leblanc, Stéphane Béchet, Jonathan Derman, Isaac Fassler, Bertrand Brieau

Registry-linked trialAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06933576 (Contribution of the EyeMAX™ 11Fr), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06933576 completednot on this map

Contribution of the EyeMAX™ 11Fr (Micro-Tech) Digital Single-Operator Cholangioscope With a Wide Working Channel: A Multicenter Pilot Study on the First French Experiences.

TypeobservationalSponsorClinique Paris-BercyRan2024 to 2025Enrolled28ConditionsCholangiocarcinoma, Biliary Stenosis, Bile Duct Stones, Bile Duct StenosisArmsDSOC EyeMAX 11Fr
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

David KarsentiDigestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, 9 Quai de Bercy, Charenton-le-Pont 94220, France.ORCID https://orcid.org/0000-0003-1487-2814
Adrien SportesDigestive Endoscopy Unit, Arnault Tzanck Institute, Saint Laurent du Var, France.
Sarah LeblancDigestive Endoscopy Unit, Jean Mermoz Private Hospital, Ramsay-Santé, Lyon, France.
Stéphane BéchetBiostatistics Unit, SFHGL-CREGG, French Society of Private Hepato-Gastroenterology, Montpellier, France.
Jonathan DermanPathology Unit, Pôle Digestif Paris Bercy, Paris-Bercy Clinic, Charenton-le-Pont, France.
Isaac FasslerDigestive Endoscopy Unit, Louis Pasteur Clinic, Essey-les-Nancy, France.
Bertrand BrieauDigestive Endoscopy Unit, Jules Verne Clinic, Nantes, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Digital single-operator cholangioscopy (DSOC) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel. Objectives: A new DSOC system (EyeMAX™ 11Fr; Micro-Tech Endoscopy, Nanjing, China) with a 2.0-mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in France. This study reports on the first French experience. Design: A retrospective, multicenter observational study. Methods: The study on DSOC was conducted across five endoscopy units within the French Society of Private Hepato-Gastroenterology (SFHGL-CREGG). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the Spyglass™ DS II (Boston Scientific, Marlborough, MA, USA). Results: Among 28 patients, 71.5% had undergone prior endoscopic sphincterotomy. Indications were biliary strictures in 26 patients and lithiasis in 2. Strictures were located in the bile duct (41%) or hilum (59%). The mean satisfaction score was 8.69 out of 10, with the EyeMAX 11Fr rated as superior to the SpyGlass DS II in 86% of cases. The mean biopsy count was 8.52 in 13.19 min, with 100% procedural success. Pathology specimens were rich (24%), adequate (52%), low (12%), or absent (12%). Sensitivity for cholangiocarcinoma was 73.7% (14/19). Benign strictures regressed in all cases. Procedure-related complications included pain twice (7.1%), fever once (3.6%), infection once (3.6%), and pancreatitis twice (7.1%), all of which were resolved rapidly. Conclusion: This first study on the EyeMAX 11Fr DSOC highlights its ease of use, superior biopsy facilitation, and high user satisfaction, achieving 73.7% sensitivity for cholangiocarcinoma diagnosis. Trial registration: ClinicalTrials.gov ID: NCT06933576.

Indexed as

biopsycholangiocarcinomacholangioscopycytopathologyendoscopyneoplasms

Identifiers

PMID40808865
PMCPMC12344333

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.