The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients (ELSDL)
Primary Purpose
Cirrhosis, Liver, Splenectomy; Status, Portal Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic splenectomy and azygoportal disconnection
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Cirrhosis, Splenectomy, Azygoportal disconnection, Laparoscopy, Liver Reserve Function
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
Sites / Locations
- Clinical Medical College of Yangzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Group
Arm Description
Laparoscopic splenectomy and azygoportal disconnection
Outcomes
Primary Outcome Measures
Liver reserve function ICG-K at 3 months after surgery.
The level of liver reserve function ICG-K at 3 months after surgery.
Liver reserve function ICG-K at 6 months after surgery.
The level of liver reserve function ICG-K at 6 months after surgery.
Liver reserve function ICG-K at 12 months after surgery.
The level of liver reserve function ICG-K at 12 months after surgery.
Liver reserve function ICG-K at 24 months after surgery.
The level of liver reserve function ICG-K at 24 months after surgery.
Liver reserve function ICG-R 15 at 3 months after surgery.
The level of liver reserve function ICG-R 15 at 3 months after surgery.
Liver reserve function ICG-R 15 at 6 months after surgery.
The level of liver reserve function ICG-R 15 at 6 months after surgery.
Liver reserve function ICG-R 15 at 12 months after surgery.
The level of liver reserve function ICG-R 15 at 12 months after surgery.
Liver reserve function ICG-R 15 at 24 months after surgery.
The level of liver reserve function ICG-R 15 at 24 months after surgery.
Liver reserve function ICG-T/2 at 3 months after surgery.
The level of liver reserve function ICG-T/2 at 3 months after surgery.
Liver reserve function ICG-T/2 at 6 months after surgery.
The level of liver reserve function ICG-T/2 at 6 months after surgery.
Liver reserve function ICG-T/2 at 12 months after surgery.
The level of liver reserve function ICG-T/2 at 12 months after surgery.
Liver reserve function ICG-T/2 at 24 months after surgery.
The level of liver reserve function ICG-T/2 at 24 months after surgery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05325437
Brief Title
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients
Acronym
ELSDL
Official Title
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Splenectomy; Status, Portal Hypertension
Keywords
Cirrhosis, Splenectomy, Azygoportal disconnection, Laparoscopy, Liver Reserve Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Laparoscopic splenectomy and azygoportal disconnection
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic splenectomy and azygoportal disconnection
Intervention Description
The laparoscopic splenectomy and azygoportal disconnection was performed by the same surgical team.
Primary Outcome Measure Information:
Title
Liver reserve function ICG-K at 3 months after surgery.
Description
The level of liver reserve function ICG-K at 3 months after surgery.
Time Frame
3 months
Title
Liver reserve function ICG-K at 6 months after surgery.
Description
The level of liver reserve function ICG-K at 6 months after surgery.
Time Frame
6 months
Title
Liver reserve function ICG-K at 12 months after surgery.
Description
The level of liver reserve function ICG-K at 12 months after surgery.
Time Frame
12 months
Title
Liver reserve function ICG-K at 24 months after surgery.
Description
The level of liver reserve function ICG-K at 24 months after surgery.
Time Frame
24 months
Title
Liver reserve function ICG-R 15 at 3 months after surgery.
Description
The level of liver reserve function ICG-R 15 at 3 months after surgery.
Time Frame
3 months
Title
Liver reserve function ICG-R 15 at 6 months after surgery.
Description
The level of liver reserve function ICG-R 15 at 6 months after surgery.
Time Frame
6 months
Title
Liver reserve function ICG-R 15 at 12 months after surgery.
Description
The level of liver reserve function ICG-R 15 at 12 months after surgery.
Time Frame
12 months
Title
Liver reserve function ICG-R 15 at 24 months after surgery.
Description
The level of liver reserve function ICG-R 15 at 24 months after surgery.
Time Frame
24 months
Title
Liver reserve function ICG-T/2 at 3 months after surgery.
Description
The level of liver reserve function ICG-T/2 at 3 months after surgery.
Time Frame
3 months
Title
Liver reserve function ICG-T/2 at 6 months after surgery.
Description
The level of liver reserve function ICG-T/2 at 6 months after surgery.
Time Frame
6 months
Title
Liver reserve function ICG-T/2 at 12 months after surgery.
Description
The level of liver reserve function ICG-T/2 at 12 months after surgery.
Time Frame
12 months
Title
Liver reserve function ICG-T/2 at 24 months after surgery.
Description
The level of liver reserve function ICG-T/2 at 24 months after surgery.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-Qing Jiang, MD
Phone
+8651487373272
Email
jgqing2003@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dou-Sheng Bai, MD
Phone
+8651487373372
Email
bdsno1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
Organizational Affiliation
Clinical Medical College of Yangzhou University
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Medical College of Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
Phone
86-514-87373372
Email
jgqing2003@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dou-Sheng Bai, MD
Phone
86-514-87373372
Email
bdsno1@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
First Name & Middle Initial & Last Name & Degree
Tian-Ming Gao, MD
12. IPD Sharing Statement
Learn more about this trial
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients
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