Fundal Gastric VaricesNCT07263503
Clip and Coil in Fundal Gastric Varices With a Large Shunt
An observational study of Fundal Gastric Varices and Endoscopic Ultrasound (EUS)-Guided Coil Deployment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Endoscopic ultrasound (EUS)-guided coil deployment is a promising technique for the endoscopic management of gastric varices. However, coil migration may occur in patients with large drainage collaterals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fundal Gastric Varices, Endoscopic Ultrasound (EUS)-Guided Coil Deployment, Titanium Clips
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 31 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with fundal gastric varices, admitted for endoscopic intervention
Who may be able to join
- presence of a spontaneous portosystemic shunt, including gastrorenal or splenorenal collateral shunts;
- use of both clips and coils during endoscopic intervention.
Who cannot join
- The spontaneous portosystemic shunt was narrow (diameter < 1.0 cm).
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
About this study
Official title: Clip and Coil: A Novel Safe Strategy in Managing Fundal Gastric Varices With a Large Spontaneous Portosystemic Shunt
Endoscopic ultrasound (EUS)-guided coil deployment is a promising technique for the endoscopic management of gastric varices. However, coil migration may occur in patients with large drainage collaterals. This study aimed to evaluate the safety and efficacy of using clips in combination with coils for treating gastric varices. In this retrospective study, clips were placed before EUS-guided coil deployment in each patient with gastric varices and a large spontaneous portosystemic shunt. The pressure of gastric varices was directly measured by puncturing the varix with a needle connected to a pressure transducer, before and after clip placement. The occurrence of ectopic embolization or coil migration was recorded.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fundal gastric varices associated with a large spontaneous portosystemic shunt (>1cm) | Clips were placed before EUS-guided coil deployment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of ectopic embolization
Measured: Within the day of the endoscopic intervention (after the operation)
Secondary outcomes (1)
The occurrence of coil migration
Measured: Within the day of the endoscopic intervention (after the operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start20 Feb 2024
- Primary completion16 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fundal Gastric VaricesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263503
- Sponsor's protocol ID
- 2025-1588
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clip and Coil: A Novel Safe Strategy in Managing Fundal Gastric Varices With a Large Spontaneous Portosystemic Shunt
- ClinicalTrials.gov ID
- NCT07263503
- Acronym / sponsor ID
- 2025-1588
- Conditions
- Fundal Gastric Varices, Endoscopic Ultrasound (EUS)-Guided Coil Deployment, Titanium Clips, Ectopic Embolization, Gastric Variceal Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 4 Dec 2025 (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.
Endoscopic ultrasound (EUS)-guided coil deployment is a promising technique for the endoscopic management of gastric varices. However, coil migration may occur in patients with large drainage collaterals. This study aimed to evaluate the safety and efficacy of using clips in combination with coils for treating gastric varices. In this retrospective study, clips were placed before EUS-guided coil deployment in each patient with gastric varices and a large spontaneous portosystemic shunt. The pressure of gastric varices was directly measured by puncturing the varix with a needle connected to a pressure transducer, before and after clip placement. The occurrence of ectopic embolization or coil migration was recorded.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fundal gastric varices associated with a large spontaneous portosystemic shunt (>1cm) | – | –Clips were placed before EUS-guided coil deployment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with fundal gastric varices, admitted for endoscopic intervention
Key inclusion criteria (2 listed)
- presence of a spontaneous portosystemic shunt, including gastrorenal or splenorenal collateral shunts;
- use of both clips and coils during endoscopic intervention.
Key exclusion criteria (1 listed)
- The spontaneous portosystemic shunt was narrow (diameter < 1.0 cm).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The occurrence of ectopic embolization
Time frame: Within the day of the endoscopic intervention (after the operation)
1 secondary outcome
The occurrence of coil migration
Time frame: Within the day of the endoscopic intervention (after the operation)
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 4 Dec 2025.
- Individual participant dataSharing planned: No
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 Fundal Gastric Varices and Endoscopic Ultrasound (EUS)-Guided Coil Deployment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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 4 Dec 2025. 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 occurrence of ectopic embolization (time frame: Within the day of the endoscopic intervention (after the operation)). 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 4 Dec 2025.