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

NCT06247891 | Completed

• 1 other identifier: 2021309
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Endocytoscopy

Keywords

Endocytoscopy; acute graft-versus-host disease

Outcome Measures

Primary Outcomes (1)

• the effectiveness of endocytoscopy for diagnosing UGI aGvHD

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

  three months

Study Arms (1)

Control Group

Procedure: ECS Group

Interventions

ECS Group PROCEDURE

Patients underwent endoscopic and endocytoscopic evaluations.

Control Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \< 14 year
• with underlying gastrointestinal disease before allo-HSCT
• incomplete medical information

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ye Zhao

Shanghai, 210000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 8, 2024
• Study Start: August 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: May 31, 2025
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)