Evidence map›Paper›PMID 37463599›Full record

Trial reportEndoscopy2023

Global prospective case series of ERCPs using a single-use duodenoscope.

Marco J Bruno, Torsten Beyna, David Carr-Locke, Prabhleen Chahal, Guido Costamagna, Benedict Devereaux, Marc Giovannini, Mahesh K Goenka, Christopher Khor, James Lau and 17 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Endoscopy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% of its field
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.

NCT06581016 narecruitingnot on this mapstarted 2024, after this paper: background citation

Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients

TypeinterventionalSponsorZealand University HospitalRan2024 to 2026Enrolled700ConditionsUpper Gastrointestinal DisorderArmsAmbu aScope Gastro, Ambu aScope Gastro Large, Diagnostic gastroscopes, Olympus, Therapeutic gastroscopes, Olympus
NCT06771102 narecruitingnot on this mapstarted 2025, after this paper: background citation

Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients

TypeinterventionalSponsorZealand University HospitalRan2025 to 2027Enrolled180ConditionsUpper Gastrointestinal DisorderArmsAmbu aScope Gastro, Diagnostic gastroscopes, Olympus
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 12 countries.

Marco J BrunoDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, University Medical Center, Rotterdam, The Netherlands.
Torsten BeynaDepartment of Internal Medicine, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.ORCID 0000-0003-3071-0428
David Carr-LockeDivision of Gastroenterology & Hepatology, New York Presbyterian Hospital, Weill Cornell Medicine, New York, New York, USA.
Prabhleen ChahalGastroenterology and Hepatology, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Guido CostamagnaFondazione Policlinico Universitario Agostino Gemelli IRCCS (Università Cattolica del Sacro Cuore), Rome, Italy.ORCID 0000-0002-8100-2731
Benedict DevereauxDepartment of Gastroenterology, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia.
Marc GiovanniniEndoscopy Unit, Institut Paoli-Calmettes, Marseille, France.
Mahesh K GoenkaDepartment of Gastroenterology, Apollo Multispecialty Hospitals, Kolkata, India.
Christopher KhorDepartment of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.
James LauPrince of Wales Hospital, Hong Kong, China.
Gary MayThe Centre for Therapeutic Endoscopy and Endoscopic Oncology, Division of Gastroenterology, St. Michael's Hospital, Alberta, Canada.
V Raman MuthusamyVatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine at UCLA, University of California, Los Angeles, California, USA.
Sandeep PatelDivision of Gastroenterology, UT Health San Antonio, San Antonio, Texas, USA.
Bret T PetersenDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Douglas K PleskowCenter for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0003-0092-9496
Isaac RaijmanTexas International Endoscopy Center, Houston, Texas, USA.
D Nageshwar ReddyAsian Institute of Gastroenterology, Hyderabad, India.
Alessandro RepiciEndoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy.
Andrew S RossDepartment of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington.
Divyesh V SejpalDigestive Disease Institute, Dignity/CommonSpirit Health, Creighton School of Medicine, Phoenix, Arizona, USA.
Stuart ShermanDivision of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, Indiana, USA.
Uzma D SiddiquiCenter for Endoscopic Research and Therapeutics (CERT), University of Chicago, Chicago, Illinois, USA.
Christopher ZiadyDr. George Mukhari Academic Medical Center, Pretoria, South Africa.
Joyce A PeetermansEndoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts, USA.
Matthew J RousseauEndoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts, USA.
Adam SlivkaDepartment of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
EXALT Single-use Duodenoscope Study Group
Boston Scientific (United States) · USAsian Institute of Gastroenterology · INBeth Israel Deaconess Medical Center · USChinese University of Hong Kong · HKCleveland Clinic · USCreighton University · USDr George Mukhari Hospital · ZAErasmus MC · NLEvangelisches Krankenhaus Düsseldorf · DEHumanitas University · ITIndiana University – Purdue University Indianapolis · USInstitut Paoli-Calmettes · FRMayo Clinic · USNewYork–Presbyterian Hospital · USSingapore General Hospital · SGSt. Michael's Hospital · CATexas A&M International University · USThe University of Queensland · AUThe University of Texas Health Science Center at San Antonio · USUniversità Cattolica del Sacro Cuore · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas.

methods61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs).

resultsAmong 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis.

conclusionsIn academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

Indexed as

Cholangiopancreatography, Endoscopic RetrogradePancreatitisAdultDuodenoscopesEndoscopy, GastrointestinalFemaleHumansMale

Identifiers

PMID37463599
PMCPMC10684334
OpenAlexW4384661392

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.