Reusable Versus Disposable Duodenoscopes for ERCP

NCT04143698 | Completed FDA Device

• 1 other identifier: 1388902
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized trial is to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the disposable (single-use) and reusable duodenoscopes.

Conditions

Endoscopic Retrograde Cholangiopancreatography

Keywords

duodenoscopes; ERCP

Outcome Measures

Primary Outcomes (1)

• Cannulation

  The ease of cannulation of the desired duct (biliary or pancreatic), as measured by the total number of cannulation attempts to achieve successful cannulation of the desired duct.

  1 day

Secondary Outcomes (7)

• Ease of passage of duodenoscope and imaging and mechanical function of the duodenoscope

  1 day

• Ease of completion of interventions

  1 day

• Rate of use of advanced cannulation techniques

  1 day

• Rate of cross-over

  1 day

• Time taken for cannulation

  1 day

Study Arms (2)

Disposable (single-use) duodenoscope

ACTIVE COMPARATOR

This group will be using the disposable (single-use) duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).

Device: endoscopic retrograde cholangiopancreatography

Reusable duodenoscope

ACTIVE COMPARATOR

This group will be using the reusable duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).

Device: endoscopic retrograde cholangiopancreatography

Interventions

endoscopic retrograde cholangiopancreatography DEVICE

The duodenoscope will be passed to the duodenum in the standard fashion. Once the papilla has been identified in the duodenum, cannulation of the desired duct will be performed in the standard fashion, with the type of accessories used left to the discretion of the individual endoscopist performing the procedure. If cannulation is considered difficult, advanced cannulation techniques can be used per standard of care at the discretion of the individual endoscopist. The types of accessories used will be left to the discretion of the individual endoscopist and will be dependent on procedure indication and personal preference. Cross-over to the alternate duodenoscope type can be performed at any time if the desired technical maneuver cannot be performed with the designated duodenoscope.

Also known as: ERCP

Disposable (single-use) duodenoscope; Reusable duodenoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Patients with native papilla
• Requiring an ERCP procedure for biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at computed tomography or magnetic resonance cholangiopancreatography

You may not qualify if:

• Age \<18 years old
• Unable to obtain informed consent
• Pregnancy
• Altered upper gastrointestinal surgical anatomy
• Patients with percutaneous transhepatic biliary drainage catheters
• Prior history of ERCP

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Related Publications (13)

• Rauwers AW, Voor In 't Holt AF, Buijs JG, de Groot W, Hansen BE, Bruno MJ, Vos MC. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut. 2018 Sep;67(9):1637-1645. doi: 10.1136/gutjnl-2017-315082. Epub 2018 Apr 10.

  PMID: 29636382 BACKGROUND

• Kim S, Russell D, Mohamadnejad M, Makker J, Sedarat A, Watson RR, Yang S, Hemarajata P, Humphries R, Rubin Z, Muthusamy VR. Risk factors associated with the transmission of carbapenem-resistant Enterobacteriaceae via contaminated duodenoscopes. Gastrointest Endosc. 2016 Jun;83(6):1121-9. doi: 10.1016/j.gie.2016.03.790. Epub 2016 Mar 16.

  PMID: 26993149 BACKGROUND

• Alrabaa SF, Nguyen P, Sanderson R, Baluch A, Sandin RL, Kelker D, Karlapalem C, Thompson P, Sams K, Martin S, Montero J, Greene JN. Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. Am J Infect Control. 2013 Jun;41(6):562-4. doi: 10.1016/j.ajic.2012.07.008. Epub 2012 Nov 18.

  PMID: 23171594 BACKGROUND

• Epstein L, Hunter JC, Arwady MA, Tsai V, Stein L, Gribogiannis M, Frias M, Guh AY, Laufer AS, Black S, Pacilli M, Moulton-Meissner H, Rasheed JK, Avillan JJ, Kitchel B, Limbago BM, MacCannell D, Lonsway D, Noble-Wang J, Conway J, Conover C, Vernon M, Kallen AJ. New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA. 2014 Oct 8;312(14):1447-55. doi: 10.1001/jama.2014.12720.

  PMID: 25291580 BACKGROUND

• Cotton PB, Eisen G, Romagnuolo J, Vargo J, Baron T, Tarnasky P, Schutz S, Jacobson B, Bott C, Petersen B. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc. 2011 May;73(5):868-74. doi: 10.1016/j.gie.2010.12.036. Epub 2011 Mar 5.

  PMID: 21377673 BACKGROUND

• Sahar N, La Selva D, Gluck M, Gan SI, Irani S, Larsen M, Ross AS, Kozarek RA. The ASGE grading system for ERCP can predict success and complication rates in a tertiary referral hospital. Surg Endosc. 2019 Feb;33(2):448-453. doi: 10.1007/s00464-018-6317-7. Epub 2018 Jul 9.

  PMID: 29987568 BACKGROUND

• Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.

  PMID: 27299638 BACKGROUND

• Liao WC, Angsuwatcharakon P, Isayama H, Dhir V, Devereaux B, Khor CJ, Ponnudurai R, Lakhtakia S, Lee DK, Ratanachu-Ek T, Yasuda I, Dy FT, Ho SH, Makmun D, Liang HL, Draganov PV, Rerknimitr R, Wang HP. International consensus recommendations for difficult biliary access. Gastrointest Endosc. 2017 Feb;85(2):295-304. doi: 10.1016/j.gie.2016.09.037. Epub 2016 Oct 5. No abstract available.

  PMID: 27720741 BACKGROUND

• Bassi M, Luigiano C, Ghersi S, Fabbri C, Gibiino G, Balzani L, Iabichino G, Tringali A, Manta R, Mutignani M, Cennamo V. A multicenter randomized trial comparing the use of touch versus no-touch guidewire technique for deep biliary cannulation: the TNT study. Gastrointest Endosc. 2018 Jan;87(1):196-201. doi: 10.1016/j.gie.2017.05.008. Epub 2017 May 18.

  PMID: 28527615 BACKGROUND

• Hwang JC, Yoo BM, Yang MJ, Lee YK, Lee JY, Lim K, Noh CK, Cho HJ, Kim SS, Kim JH. A prospective randomized study of loop-tip versus straight-tip guidewire in wire-guided biliary cannulation. Surg Endosc. 2018 Apr;32(4):1708-1713. doi: 10.1007/s00464-017-5851-z. Epub 2017 Sep 15.

  PMID: 28916891 BACKGROUND

• Bassan MS, Sundaralingam P, Fanning SB, Lau J, Menon J, Ong E, Rerknimitr R, Seo DW, Teo EK, Wang HP, Reddy DN, Goh KL, Bourke MJ. The impact of wire caliber on ERCP outcomes: a multicenter randomized controlled trial of 0.025-inch and 0.035-inch guidewires. Gastrointest Endosc. 2018 Jun;87(6):1454-1460. doi: 10.1016/j.gie.2017.11.037. Epub 2018 Jan 6.

  PMID: 29317269 BACKGROUND

• Buxbaum J, Leonor P, Tung J, Lane C, Sahakian A, Laine L. Randomized Trial of Endoscopist-Controlled vs. Assistant-Controlled Wire-Guided Cannulation of the Bile Duct. Am J Gastroenterol. 2016 Dec;111(12):1841-1847. doi: 10.1038/ajg.2016.268. Epub 2016 Jul 5.

  PMID: 27377519 BACKGROUND

• Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut. 2021 May;70(5):838-844. doi: 10.1136/gutjnl-2020-321836. Epub 2020 Sep 7.

  PMID: 32895332 DERIVED

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Shyam Varadarajulu, MD

  AdventHealth Orlando

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: October 29, 2019
• Study Start: January 24, 2020
• Primary Completion: March 20, 2020
• Study Completion: May 6, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)