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Effect of LSD on Renal Function in Cirrhotic Patients With Portal Hypertension

9 settembre 2026 aggiornato da: Guo-Qing Jiang, Northern Jiangsu People's Hospital

Effect of Laparoscopy Splenectomy and Azygoportal Disconnectionon Renal Function in Cirrhotic Patients With Portal Hypertension

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.

Panoramica dello studio

Descrizione dettagliata

Liver cirrhosis is associated with systemic hemodynamic disturbances, reduced effective circulating volume, and renal hypoperfusion, creating a high risk of renal dysfunction and hepatorenal syndrome (HRS)-a life-threatening condition reflecting the critical hepatorenal interaction. Patients with cirrhosis and portal hypertension frequently have subclinical or overt renal impairment preoperatively. Laparoscopy splenectomy and azygoportal disconnection (LSD) is a standard intervention for cirrhotic patients with portal hypertension, but its impact on long-term renal function recovery remains unclear.

This single-center retrospective cohort study will be conducted at the Department of Hepatobiliary Surgery, Subei People's Hospital Affiliated to Yangzhou University, Yangzhou, China. We will retrospectively collect clinical and follow-up data from patients with liver cirrhosis and portal hypertension who underwent LSD between February 2012 and February 2025.

Patients will be stratified into two groups based on preoperative estimated glomerular filtration rate (eGFR): impaired renal function group (<90 mL/min/1.73m²) and normal renal function group (≥90 mL/min/1.73m²). Kidney function will be assessed using eGFR calculated with the 2021 CKD-EPI creatinine equation at five time points: preoperative baseline and postoperative months 3, 6, 9, and 12.

Statistical analyses will include linear mixed-effects models (LMM) to evaluate eGFR change trajectories and group differences over time; multivariable linear regression to identify factors independently associated with eGFR change (ΔeGFR = postoperative month 12 eGFR - preoperative eGFR); and multivariable logistic regression (limited to patients with baseline eGFR <90 mL/min/1.73m²) to identify predictors of renal function recovery to normal (eGFR ≥90 mL/min/1.73m²).

The study aims to evaluate whether LSD is associated with kidney function improvement in patients with liver cirrhosis and portal hypertension, whether the degree of improvement differs between patients with and without pre-existing renal impairment, and whether preoperative factors such as ascites severity are associated with the magnitude of renal function recovery. These findings may help fill an important gap in understanding the hepatorenal axis after LSD and guide perioperative renal protection strategies in this high-risk population.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

496

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
LSD-treated Patients with Liver Cirrhosis and Portal Hypertension
Patients who underwent laparoscopy splenectomy and azygoportal disconnection for liver cirrhosis with portal hypertension
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum Creatinine (Scr) Level
Lasso di tempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
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)
Lasso di tempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Blood Urea Nitrogen (BUN) Level
Lasso di tempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Changes in BUN level as additional indicators of renal function.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Blood Uric Acid (UA) Level
Lasso di tempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Changes in UA level as additional indicators of renal function.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Postoperative Complications
Lasso di tempo: At postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12
Postoperative complications including bleeding, infection, hepatic encephalopathy, and ascites.
At postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12
Albumin
Lasso di tempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Changes in serum albumin levels.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Total Bilirubin Level
Lasso di tempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Changes in serum total bilirubin levels.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: guoqing jiang, Clinical Medical College, Yangzhou University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 febbraio 2012

Completamento primario (Effettivo)

1 febbraio 2026

Completamento dello studio (Effettivo)

1 agosto 2026

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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