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Completed

NCT Number: NCT06247891

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

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.

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Key information

Conditions

Endocytoscopy

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ye Zhao

Shanghai, 210000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECS Group

Procedure

Patients underwent endoscopic and endocytoscopic evaluations.

Primary outcomes

  1. the effectiveness of endocytoscopy for diagnosing UGI aGvHD

    Time frame: three months

    the percentage of esophageal, gastric, and duodenal UGI aGvHD diagnosed by endocytoscopy

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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