Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)

NCT07585773 | Not Yet Recruiting

• 1 other identifier: YZUC-020
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 is commonly used to treat splenomegaly and hypersplenism 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 laparoscopic splenectomy can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .

Conditions

Cirrhosis; Splenectomy; Status; Hypersplenism; Kidney Function Issue

Keywords

Cirrhosis; Portal Hypertension; Splenectomy; Laparoscopy; Hypersplenism

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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)

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

• 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

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 scheduled for elective laparoscopic splenectomy 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
• No 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
• Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
• Cirrhotic complications (portal hypertension bleeding, hepatic encephalopathy, 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

Study Sites (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

Fibrosis; Hypersplenism; Hypertension, Portal

Condition Hierarchy (Ancestors)

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

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

Locations

CN (1)