Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla

NCT ID: NCT02883608

Last Updated: 2017-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side\*viewing duodenoscope for complete examination of MDP.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Duodenal Papilla, Major

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Initial cap assisted endoscopy

undergo initial cap assisted forward-viewing endoscope then side-viewing duodenoscope

Group Type EXPERIMENTAL

cap assisted forward-viewing endoscope

Intervention Type PROCEDURE

a cap fitted to the to top of the forward-viewing endoscope

Initial standard endoscopy

undergo initial side-viewing duodenoscope then cap assisted forward-viewing endoscope

Group Type ACTIVE_COMPARATOR

cap assisted forward-viewing endoscope

Intervention Type PROCEDURE

a cap fitted to the to top of the forward-viewing endoscope

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cap assisted forward-viewing endoscope

a cap fitted to the to top of the forward-viewing endoscope

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* indication for elective upper endoscopy
* age over 18 years
* ability to provide informed consent

Exclusion Criteria

* surgically altered upper gastrointestinal tract
* known or suspected upper gastrointestinal strictures
* upper gastrointestinal bleeding
* biliary stent
* planned endoscopic intervention
* American Society of Anesthesiologists class III or higher
* contraindication for or refusal of sedation with Propofol
* inability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Abdelhafez

Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Abdelhafez M, Phillip V, Hapfelmeier A, Sturm V, Elnegouly M, Dollhopf M, Kassem A, Klare P, Nennstiel S, Schmid RM, von Delius S, Eckel F. Comparison of cap-assisted endoscopy vs. side-viewing endoscopy for examination of the major duodenal papilla: a randomized, controlled, noninferiority crossover study. Endoscopy. 2019 May;51(5):419-426. doi: 10.1055/a-0662-5445. Epub 2018 Sep 10.

Reference Type DERIVED
PMID: 30199900 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

216/16 s

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.