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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05325424
Other study ID # YZUC-006
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date October 1, 2024

Study information

Verified date December 2023
Source Northern Jiangsu People's Hospital
Contact Guo-Qing Jiang, MD
Phone +8651487373272
Email jgqing2003@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy. To determine whether surgical treatment can help enhance postoperative liver reserve function and improve patient prognosis.


Description:

The patients were enrolled according to the research criteria, and collected the general basic information of the patients. After the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy, and the same nursing team performed the nursing after the operation. Then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. During the treatment, the liver reserve function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including TBIL, DBIL, ALB, ALT, INR, PT, Child-Pugh, ascites, prealbumin, ICG-K, ICG-R 15 and ICG-T/2.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - A clinical, radiological or histologic diagnosis of cirrhosis of any etiology - Splenomegaly with secondary hypersplenism, Platelet count < 50*10^9/L - Informed consent to participate in the study Exclusion Criteria: - Hepatocellular carcinoma or any other malignancy, - Child-Pugh grade C - Recent peptic ulcer disease - History of Hemorrhagic stroke - Pregnancy. - Uncontrolled Hypertension - Bleeding portal hypertension - Human immunodeficiency virus (HIV) infection

Study Design


Intervention

Procedure:
Laparoscopic splenectomy
The laparoscopic splenectomy was performed by the same surgical team.

Locations

Country Name City State
China Clinical Medical College of Yangzhou University Yangzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Liver reserve function ICG-K level at 3 months after surgery The level of liver reserve function ICG-K level at 3 months after surgery. 3 months
Primary Liver reserve function ICG-K level at 6 months after surgery. The level of liver reserve function ICG-K level at 6 months after surgery. 6 months
Primary Liver reserve function ICG-K level at 12 months after surgery The level of liver reserve function ICG-K level at 12 months after surgery. 12 months
Primary Liver reserve function ICG-K level at 24 months after surgery. The level of liver reserve function ICG-K level at 24 months after surgery. 24 months
Primary Liver reserve function ICG-R15 level at 3 months after surgery. The level of liver reserve function ICG-R15 level at 3 months after surgery. 3 months
Primary Liver reserve function ICG-R15 level at 6 months after surgery. The level of liver reserve function ICG-R15 level at 6 months after surgery. 6 months
Primary Liver reserve function ICG-R15 level at 12 months after surgery. The level of liver reserve function ICG-R15 level at 12 months after surgery. 12 months
Primary Liver reserve function ICG-R15 level at 24 months after surgery. The level of liver reserve function ICG-R15 level at 24 months after surgery. 24 months
Primary Liver reserve function ICG-T/2 level at 3 months after surgery. The level of liver reserve function ICG-T/2 level at 3 months after surgery. 3 months
Primary Liver reserve function ICG-T/2 level at 6 months after surgery. The level of liver reserve function ICG-T/2 level at 6 months after surgery. 6 months
Primary Liver reserve function ICG-T/2 level at 12 months after surgery. The level of liver reserve function ICG-T/2 level at 12 months after surgery. 12 months
Primary Liver reserve function ICG-T/2 level at 24 months after surgery. The level of liver reserve function ICG-T/2 level at 24 months after surgery. 24 months
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