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

June 22, 2026 updated by: Ruijin Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 210000
        • Ye Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent first allogeneic hematopoietic stem cell transplantation at Ruijin Hospital and developed persistent upper gastrointestinal symptoms after neutrophil engraftment were screened. Eligible participants were those with suspected upper gastrointestinal acute graft-versus-host disease whose symptoms did not resolve after at least 72 hours of supportive care and who underwent conventional endoscopy combined with endocytoscopy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Procedure: ECS Group
Patients underwent endoscopic and endocytoscopic evaluations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effectiveness of endocytoscopy for diagnosing UGI aGvHD
Time Frame: three months
the percentage of esophageal, gastric, and duodenal UGI aGvHD diagnosed by endocytoscopy
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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