NCT07811713

Brief Summary

Patients with liver cirrhosis and portal hypertension often have impaired kidney function due to reduced blood flow to the kidneys and fluid buildup in the abdomen (ascites). Laparoscopy splenectomy and azygoportal disconnection (LSD) is a minimally invasive surgery commonly used to treat bleeding from swollen veins in these patients, but its impact on kidney function recovery remains unclear. This study will review medical records of patients with liver cirrhosis and portal hypertension who underwent LSD at our hospital. We will measure kidney function using estimated glomerular filtration rate (eGFR) before surgery and at 3, 6, 9, and 12 months after surgery to evaluate changes over time. We will also examine whether factors such as fluid buildup in the abdomen (ascites) before surgery are associated with kidney function changes after LSD. The goal is to better understand how LSD affects kidney function in these patients and to identify factors that may predict kidney function recovery, which could help improve care for cirrhotic patients undergoing this surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

14 years

First QC Date

August 11, 2026

Last Update Submit

September 9, 2026

Conditions

Keywords

CirrhosisSplenectomyLaparoscopyazygoportal disconnectionRenal functionPortal hypertension bleeding

Outcome Measures

Primary Outcomes (2)

  • Serum Creatinine (Scr) Level

    Change in serum creatinine (Scr) level, used for eGFR calculation.

    At preoperative baseline, postoperative month 3, month 6, month 9, month 12

  • Estimated Glomerular Filtration Rate (eGFR)

    Change in estimated glomerular filtration rate (eGFR) calculated using the 2021 CKD-EPI creatinine equation. eGFR was assessed at preoperative baseline and postoperative months 3, 6, 9, and 12 to evaluate longitudinal renal function changes.

    At preoperative baseline, postoperative month 3, month 6, month 9, month 12

Secondary Outcomes (5)

  • Blood Urea Nitrogen (BUN) Level

    At preoperative baseline, postoperative month 3, month 6, month 9, month 12

  • Blood Uric Acid (UA) Level

    At preoperative baseline, postoperative month 3, month 6, month 9, month 12

  • Postoperative Complications

    At postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12

  • Albumin

    At preoperative baseline, postoperative month 3, month 6, month 9, month 12

  • Total Bilirubin Level

    At preoperative baseline, postoperative month 3, month 6, month 9, month 12

Study Arms (1)

LSD-treated Patients with Liver Cirrhosis and Portal Hypertension

Patients who underwent laparoscopy splenectomy and azygoportal disconnection for liver cirrhosis with portal hypertension

Procedure: Laparoscopic splenectomy and azygoportal disconnection

Interventions

A minimally invasive surgical procedure involving laparoscopic removal of the spleen and ligation of perigastric and esophageal varices to reduce portal hypertension and prevent variceal bleeding.

LSD-treated Patients with Liver Cirrhosis and Portal Hypertension

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a retrospective, single-center, observational cohort study. The study population consists of adult patients with liver cirrhosis, splenomegaly and hypersplenism, and portal hypertension bleeding who underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at the Department of Hepatobiliary Surgery, Subei People's Hospital Affiliated to Yangzhou University between February 2012 and February 2025. Patients were identified from electronic medical records and followed for up to 12 months postoperatively to assess renal function dynamics. The study aimed to evaluate the effect of LSD on renal function recovery and identify factors associated with postoperative renal outcomes in this high-risk population.

You may qualify if:

  • Age ≥18 years.
  • Diagnosis of liver cirrhosis with portal hypertension.
  • Underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at our institution.
  • Adequate preoperative and postoperative clinical and follow-up data for analysis.
  • Preoperative and postoperative eGFR data available at the specified time points (baseline, month 3, 6, 9, and 12).

You may not qualify if:

  • Child-Pugh Class C liver cirrhosis.
  • Primary renal diseases (e.g., glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.).
  • Previous abdominal surgery that precluded safe laparoscopic splenectomy and azygoportal disconnection (LSD).
  • Severe cardiac, pulmonary, or cerebrovascular dysfunction; malignant tumors; or primary hematological disorders.
  • Hepatic encephalopathy or refractory ascites within 1 month before surgery.
  • Pregnancy or lactation.
  • Poor compliance or inability to complete follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver CirrhosisHypertension, PortalFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • guoqing jiang

    Clinical Medical College, Yangzhou University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 11, 2026

First Posted

September 10, 2026

Study Start

February 1, 2012

Primary Completion

February 1, 2026

Study Completion

August 1, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09