Endocytoscopy of Upper Gastrointestinal Tract in Acute Graft-versus-host Disease: a Pilot Study

NCT ID: NCT06247891

Last Updated: 2024-02-08

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-11-30

Brief Summary

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The goal of this clinical trial is to test the assess the diagnostic effectiveness of endocytoscopy in patients with underlying UGI aGvHD. The main question it aims to answer is: the effectiveness of ECS for diagnosing UGI aGvHD. Participants will undergo endoscopy, endocytoscopic evaluation and biopsy simultaneously. If there is a comparison group: Researchers will compare endoscopic, endocytoscopic and pathologic findings of these patients.

Detailed Description

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Conditions

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Endocytoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control Group

Group Type OTHER

ECS Group

Intervention Type PROCEDURE

Patients underwent endoscopic and endocytoscopic evaluations.

Interventions

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ECS Group

Patients underwent endoscopic and endocytoscopic evaluations.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* aged ≥ 14 years
* developed UGI symptoms within first three months after engraftment or during the tapering of immunosuppressive agents

Exclusion Criteria

* \< 14 year
* with underlying gastrointestinal disease before allo-HSCT
* incomplete medical information
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ye Zhao

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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2023309

Identifier Type: -

Identifier Source: org_study_id

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