Clinical trial NCT05325437: The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients
Official title: The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis, Liver
Splenectomy; Status
Portal Hypertension
Keywords: Cirrhosis
Splenectomy
Azygoportal disconnection
Laparoscopy
Liver Reserve Function
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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 azygoportal disconnection, 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.

Eligibility criteria: Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
* Splenomegaly with secondary hypersplenism
* gastroesophageal variceal bleeding
* 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
* Human immunodeficiency virus (HIV) infection

Primary outcomes:
measure: Liver reserve function ICG-K at 3 months after surgery.
timeFrame: 3 months
measure: Liver reserve function ICG-K at 6 months after surgery.
timeFrame: 6 months
measure: Liver reserve function ICG-K at 12 months after surgery.
timeFrame: 12 months
measure: Liver reserve function ICG-K at 24 months after surgery.
timeFrame: 24 months
measure: Liver reserve function ICG-R 15 at 3 months after surgery.
timeFrame: 3 months
measure: Liver reserve function ICG-R 15 at 6 months after surgery.
timeFrame: 6 months
measure: Liver reserve function ICG-R 15 at 12 months after surgery.
timeFrame: 12 months
measure: Liver reserve function ICG-R 15 at 24 months after surgery.
timeFrame: 24 months
measure: Liver reserve function ICG-T/2 at 3 months after surgery.
timeFrame: 3 months
measure: Liver reserve function ICG-T/2 at 6 months after surgery.
timeFrame: 6 months
measure: Liver reserve function ICG-T/2 at 12 months after surgery.
timeFrame: 12 months
measure: Liver reserve function ICG-T/2 at 24 months after surgery.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Clinical Medical College of Yangzhou University
state: Jiangsu
Study officials:
affiliation: Clinical Medical College of Yangzhou University
name: Guo-Qing Jiang, MD
role: STUDY_CHAIR
References: