Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2018-07-20

Brief Summary

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Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP. A recent study showed that complete examination of MDP could be achieved in 97% of patients. The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.

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Detailed Description

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Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50% of the enrollment.

Conditions

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Observation of Major Duodenal Papilla (MDP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Cap group: Cap-EGD

Undergoing cap-assisted esophagogastroduodenoscopy

Group Type EXPERIMENTAL

Cap-EGD

Intervention Type DEVICE

Undergoing cap-assisted endoscopy

Duo group: Duo

Undergoing side-viewing duodenoscope

Group Type ACTIVE_COMPARATOR

Duo

Intervention Type DEVICE

Undergoing side-viewing duodenoscope

Interventions

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Cap-EGD

Undergoing cap-assisted endoscopy

Intervention Type DEVICE

Duo

Undergoing side-viewing duodenoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years and \< 70 years
* Patients with native MDP who underwent ERCP

Exclusion Criteria

* Prior surgery in upper GI tract
* Prior history of endoscopic sphincterotomy
* Prior history of MDP treatment
* Known or suspected obstruction of upper GI tract
* Patients in poor condition who may not be suitable for Ca-EGD or duodenoscope
* Pregnancy or lactic women
* Inability to give informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No