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

Not Applicable

Completed

• Conditions: Endocytoscopy
• Interventions: Procedure: ECS Group

• Registration Number: NCT06247891
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2023-08-30
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	ECS Group	-

Primary Outcome Measures

Name	Time	Method
the effectiveness of endocytoscopy for diagnosing UGI aGvHD	three months	the percentage of esophageal, gastric, and duodenal UGI aGvHD diagnosed by endocytoscopy

Trial Locations

Locations (1)

Ye Zhao; 🇨🇳 Shanghai, China