CClinicalTrials.gg
Not yet recruitingNCT06153914Updated Dec 1, 2023

SALT for Patients With Hepatic Cirrhosis

An interventional study of Sequential Adult Left Lateral Liver Transplantation in Liver Cirrhosis and Liver, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Hepatitis B virus (HBV) infection is a very difficult public health problem in the world. Patients often experience the trilogy of "hepatitis-cirrhosis-liver cancer". Patients with decompensated cirrhosis may develop a variety of complications, such as portal hypertension, hypersplenism, esophageal and gastric variceal bleeding, ascites, spontaneous peritonitis, hepatic encephalopathy, etc.

Liver transplantation is the only way to cure hepatitis B cirrhosis. However, the shortage of liver donors still severely limits its development. In 2015, Line and others proposed a new surgical method, namely resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID). This surgery innovatively combines auxiliary liver transplantation and ALLPS surgery, which can greatly alleviate the problem of liver donor shortage and improve the overall prognosis of the above-mentioned patients.

Our center has designed the Sequential Adult Left Lateral Liver Transplantation (SALT) procedure based on the principles of RAPID surgery and the characteristics of patients with cirrhosis. Compared with RAPID surgery, SALT surgery can dynamically monitor and regulate the blood flow of the residual liver and transplanted liver, reducing the risk caused by portal hypertension. This study will evaluate the safety and effectiveness of SALT in the treatment of post-hepatitis B cirrhosis.

02

Conditions studied

  • Liver Cirrhosis
  • Liver
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 47 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ①Age 18-75 years old;

    • Have a history of hepatitis B infection;

      • The imaging results are consistent with the manifestations of liver cirrhosis;

        • One of the following conditions: Meld score 15-40 points, esophageal and gastric variceal bleeding, refractory ascites, recurrent hepatic encephalopathy, hepatorenal syndrome, or hepatopulmonary syndrome; ⑤PS score 0-1 points; ⑥Sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • ①Severe thrombosis or cavernous degeneration in the portal vein system, and liver transplantation is contraindicated upon evaluation;

    • Hepatic encephalopathy stage IV;

      • Pulmonary arterial hypertension (moderate to high risk, WHO grade III-IV) that does not improve after medical treatment or is assessed to have contraindications for surgery; ④Special types of anatomical variations;

        • Inability to tolerate surgical anesthesia (such as severe infection, cardiopulmonary insufficiency, cerebrovascular disease, etc.); ⑥Severe mental illness; ⑦Other reasons that the researcher believes are not suitable for participation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    Surgical group

    This study intends to select patients with decompensated hepatitis B cirrhosis who meet the enrollment criteria and perform sequential adult left lateral lobe liver transplantation.

    Procedure: Sequential Adult Left Lateral Liver Transplantation

Interventions

  • ProcedureSequential Adult Left Lateral Liver Transplantation

    Hemihepatectomy combined with orthotopic left lateral lobe liver transplantation is performed first, and residual liver resection is performed after the graft has grown to a sufficient functional liver volume. After the two-stage surgery, we will follow up on all subjects for one year.

06

What researchers measure

Primary outcomes

  1. survival rate

    To explore the 1-year overall survival rate of patients with hepatitis B cirrhosis treated with SALT.

    Time frame: 1 month, 3 months, 6 months and 1 year post-transplant

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06153914
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Dec 1, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Dec 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion