Effect of LSD on Renal Function in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)

NCT07585786 | Not Yet Recruiting

• 1 other identifier: YZUC-022
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) is commonly used to treat Cirrhosis with Portal Hypertension Bleeding in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether LSD can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .

Conditions

Cirrhosis, Liver; Splenectomy; Status; Portal Hypertension; Renal Function Abnormal

Keywords

Cirrhosis; Splenectomy; Laparoscopy; azygoportal disconnection; Renal function; Portal hypertension bleeding

Outcome Measures

Primary Outcomes (4)

• Serum creatinine (Scr) level

  Change in serum creatinine (Scr) level

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

• Glomerular filtration rate (eGFR)

  Change in estimated glomerular filtration rate (eGFR). For females: If serum creatinine (Scr) ≤ 0.7 mg/dL: eGFR = 142 × (Scr/0.7)\^(-0.241) × (0.9938)\^Age; If Scr \> 0.7 mg/dL: eGFR = 142 × (Scr/0.7)\^(-1.200) × (0.9938)\^Age. For males: If Scr ≤ 0.9 mg/dL: eGFR = 142 × (Scr/0.9)\^(-0.302) × (0.9938)\^Age; If Scr \> 0.9 mg/dL: eGFR = 142 × (Scr/0.9)\^(-1.200) × (0.9938)\^Age. Note: Results are in mL/min/1.73 m². Age is in years.

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

• BUN and UA level

  Changes in BUN and UA level

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

• Urine albumin-to-creatinine ratio (UACR)

  Changes in urine albumin-to-creatinine ratio \[UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)\]

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Secondary Outcomes (4)

• Intraoperative variables

  During the procedure of operation

• Postoperative complications

  at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24

• Child-Pugh grade

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

• Albumin and bilirubin level

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, Splenomegaly and hypersplenism, Portal Hypertension Bleeding scheduled for Laparoscopic Splenectomy and Azygoportal Disconnection will be enrolled and followed for 2 years to assess renal function dynamics.

You may qualify if:

• Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
• Splenomegaly and hypersplenism
• History of portal hypertension bleeding (esophageal and gastric variceal bleeding )
• Age 18-80 years, male or female
• Child-Pugh Class A or B liver function
• No history of primary renal disease or acute kidney injury (AKI)
• Signed written informed consent
• Ability to complete 24-month follow-up

You may not qualify if:

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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guo-Qing Jiang, MD

  Clinical Medical College of Yangzhou University

  STUDY CHAIR

Central Study Contacts

Guo-Qing Jiang, MD

CONTACT

+8651487373272; jgqing2003@hotmail.com

Dou-Sheng Bai, MD

CONTACT

+8651487373372; bdsno1@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05