Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study

NCT03417570 | Terminated Results DMC FDA Device

• 1 other identifier: 201708210
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had a Diagnostic Yield Obtained

  -Diagnostic yield is defined as Barrett's esophagus lesions that were identified and confirmed histologically as low grade dysplasia, high grade dysplasia, intramucosal cancer, or invasive adenocarcinoma

  At the time of procedure (day 1)

Secondary Outcomes (4)

• Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap

  At the time of procedure (day 1)

• Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma

  At the time of procedure (day 1)

• Total Procedure Duration in Seconds

  At the time of procedure (day 1)

• Safety as Measured by Number of Participants With Procedure-related Adverse Events

  Through 48 hours after EGD

Study Arms (2)

Arm 1: EGD with cap first, followed by EGD without cap

EXPERIMENTAL

-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.

Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI); Device: Olympus Disposable Distal Attachment Cap

Arm 2: EGD without cap first, followed by EGD with cap

EXPERIMENTAL

-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.

Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI); Device: Olympus Disposable Distal Attachment Cap

Interventions

Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI) PROCEDURE

-The second endoscopist will be blinded to the results of the initial exam.

Also known as: EGD

Arm 1: EGD with cap first, followed by EGD without cap; Arm 2: EGD without cap first, followed by EGD with cap

Olympus Disposable Distal Attachment Cap DEVICE

-The second endoscopist will be blinded to the results of the initial exam.

Also known as: Cap

Arm 1: EGD with cap first, followed by EGD without cap; Arm 2: EGD without cap first, followed by EGD with cap

Eligibility Criteria

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

You may qualify if:

• Must be at least 18 years of age.
• Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE.
• Must be able to understand and willing to sign an IRB-approved written informed consent document.

You may not qualify if:

• Pregnant or breastfeeding.
• Prior endoscopic treatment for BE.
• Unable to tolerate sedation due to medical comorbidities.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Endoscopy, Digestive System; Narrow Band Imaging; Contraceptive Devices, Female

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Optical Imaging; Diagnostic Imaging; Investigative Techniques; Contraceptive Devices; Equipment and Supplies

Results Point of Contact

• Title: Vladimir M. Kushnir, M.D.
• Organization: Washington University School of Medicine

vkushnir@wustl.edu

314-454-5960

Study Officials

• Vladimir M Kushnir, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: January 31, 2018
• Study Start: December 22, 2017
• Primary Completion: November 15, 2021
• Study Completion: November 17, 2021
• Last Updated: September 1, 2022
• Results First Posted: July 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)