Cirrhosis, Liver Clinical Trial
— ELSLOfficial title:
The Effect of Laparoscopic Splenectomy on Liver Reserve Function for Cirrhosis Patients
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Clinical Medical College of Yangzhou University | Yangzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Northern Jiangsu People's Hospital |
China,
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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