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A new procedure may offer relief for Cirrhosis-Related fluid buildup

NCT ID NCT07755059

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study tests whether a procedure called proximal splenic artery embolization (PSAE) can reduce the need for repeated fluid drainage in adults with cirrhosis and ascites that no longer responds to water pills and diet. Participants will undergo a one-time procedure where small coils or plugs are placed in the artery supplying the spleen to slow its blood flow. The study will measure changes in the frequency and volume of fluid drainage, as well as liver pressure, symptoms, and quality of life over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Proximal splenic artery embolization (PSAE), a one-time procedure using coils or plugs to slow blood flow in the splenic artery
What this could lead to
If PSAE works, it could offer a new way to reduce the frequency of fluid drainage procedures in people with cirrhosis-related ascites who cannot undergo the standard TIPS procedure.
What could go wrong
This is a small, early-stage study without a control group, so results may not be conclusive. The procedure carries risks such as bleeding, infection, or damage to the spleen, and it may not effectively reduce fluid buildup.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years at the time of informed consent. * Decompensated cirrhosis confirmed by clinical, laboratory, radiographic, or histologic criteria. * Portal hypertension of sinusoidal origin. Pre-sinusoidal (e.g., idiopathic non-cirrhotic portal hypertension, schistosomiasis) and post-sinusoidal (e.g., Budd-Chiari syndrome, right-heart failure, constrictive pericarditis) etiologies are excluded. * Refractory or recurrent ascites defined as ascites not controlled by maximum tolerated diuretic therapy (spironolactone ≤ 400 mg/day + furosemide ≤ 160 mg/day, or maximum tolerated doses below these limits) and sodium restriction, or diuretic-intractable due to diuretic-induced complications. * Demonstrated large-volume paracentesis (LVP) dependence for ≥ 3 consecutive months prior to screening, with ≥ 2 LVP sessions per month on average during that window, documented in the institutional medical record or in external paracentesis procedure records released to the investigator. * Ineligible or relatively contraindicated for TIPS. Acceptable reasons include but are not limited to: MELD-Na \> 18 with additional risk factors, pre-existing or recurrent overt hepatic encephalopathy, advanced age with comorbidity, clinically significant cardiopulmonary disease, or anatomic contraindication. * Life expectancy ≥ 6 months in the judgment of the enrolling investigator. * Able and willing to provide written informed consent and to adhere to the study visit and assessment schedule. * Abdominal cross-sectional imaging (CT or MRI) within 60 days of enrollment confirming patency of the main portal vein and main splenic vein, and absence of findings that would contraindicate PSAE. Exclusion Criteria: * Age \< 18 years. * Unable to provide informed consent and without an appropriate legally authorized representative. * Pre-sinusoidal or post-sinusoidal portal hypertension (e.g., extrahepatic portal vein thrombosis, idiopathic non-cirrhotic portal hypertension, schistosomiasis, Budd-Chiari syndrome, hepatic sinusoidal obstruction syndrome, constrictive pericarditis, right-heart failure). * Main portal vein thrombosis, splenic vein thrombosis, or superior mesenteric vein thrombosis on screening imaging. * Active listing for liver transplantation with MELD-Na ≥ 20 at screening, or any listing status in which transplantation within 6 months is judged highly likely by the site transplant team. (Listed participants with MELD-Na \< 20 and low anticipated short-term transplant probability may be enrolled with documented site transplant-team concurrence.) * Pre-existing splenectomy, prior distal splenic artery embolization, or pre-existing splenic abscess, large splenic infarction (≥ 30% of splenic parenchyma), or splenic mass on imaging. * Active or uncontrolled systemic infection, including spontaneous bacterial peritonitis in the prior 14 days, bacteremia in the prior 14 days, or any infection requiring parenteral antibiotics at the time of screening. * Active gastrointestinal bleeding within 14 days, or untreated high-risk esophageal or gastric varices (primary prophylaxis not yet established) - treatable prior to enrollment. * Severe coagulopathy not correctable to INR ≤ 2.0 and platelets ≥ 30 × 10⁹/L on the day of the procedure. * Known severe allergy to iodinated contrast not manageable with standard pre-medication, or contrast contraindication precluding cross-sectional CT imaging. * eGFR \< 30 mL/min/1.73 m² not on renal replacement therapy, unless iodinated contrast use can be minimized per site protocol and nephrology concurrence is documented. * Pregnancy or breastfeeding. Participants of childbearing potential must have a negative serum pregnancy test at screening and agree to effective contraception through Month 6. * Hepatocellular carcinoma beyond BCLC Stage A, or any active extrahepatic malignancy with life expectancy \< 6 months. * Active substance use disorder other than alcohol or tobacco that, in the investigator's judgment, would preclude protocol adherence. Active alcohol use disorder is not exclusionary but is captured (AUDIT-C) and analyzed as a pre-specified covariate. * Enrollment in another interventional clinical trial within 30 days or concurrent with this study that could confound endpoints, including TIPS-related trials. * Any medical, psychiatric, or social condition that in the investigator's judgment would preclude safe participation or adherence to the protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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