EndocytoscopyNCT06247891
Endocytoscopy of Upper Gastrointestinal Tract in Acute Graft-versus-host Disease: a Pilot Study
An observational study of Endocytoscopy, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Endocytoscopy
- What is being tested?
- ECS Group
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- aged ≥ 14 years
- developed UGI symptoms within first three months after engraftment or during the tapering of immunosuppressive agents
Who cannot join
- < 14 year
- with underlying gastrointestinal disease before allo-HSCT
- incomplete medical information
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Endocytoscopy
- Being tested
- ECS Group
- Keywords
- Endocytoscopy, acute graft-versus-host disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECS GroupProcedure or surgery
Patients underwent endoscopic and endocytoscopic evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Not described Receives: Procedure: ECS Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effectiveness of endocytoscopy for diagnosing UGI aGvHD
the percentage of esophageal, gastric, and duodenal UGI aGvHD diagnosed by endocytoscopy
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Aug 2021
- Primary completion30 Nov 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocytoscopyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247891
- Sponsor's protocol ID
- 2021309
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocytoscopy of Upper Gastrointestinal Tract in Acute Graft-versus-host Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT06247891
- Acronym / sponsor ID
- 2021309
- Conditions
- Endocytoscopy
- Keywords
- Endocytoscopy, acute graft-versus-host disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Procedure: ECS Group |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- aged ≥ 14 years
- developed UGI symptoms within first three months after engraftment or during the tapering of immunosuppressive agents
Key exclusion criteria (3 listed)
- < 14 year
- with underlying gastrointestinal disease before allo-HSCT
- incomplete medical information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECS GroupPatients underwent endoscopic and endocytoscopic evaluations. | Procedure or surgery | Control Group |
Primary outcome
the effectiveness of endocytoscopy for diagnosing UGI aGvHD
Time frame: three months
the percentage of esophageal, gastric, and duodenal UGI aGvHD diagnosed by endocytoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocytoscopy, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effectiveness of endocytoscopy for diagnosing UGI aGvHD (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.