ELSDL: The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients

• Sponsor: Yangzhou University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05325437
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis, Liver; Splenectomy; Status; Portal Hypertension	Procedure: Laparoscopic splenectomy and azygoportal disconnection	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Laparoscopic splenectomy and azygoportal disconnection	Procedure: Laparoscopic splenectomy and azygoportal disconnection; The laparoscopic splenectomy and azygoportal disconnection was performed by the same surgical team.

Outcome Measures

Primary Outcome Measures

1. Liver reserve function ICG-K at 3 months after surgery. [3 months]

   The level of liver reserve function ICG-K at 3 months after surgery.

2. Liver reserve function ICG-K at 6 months after surgery. [6 months]

   The level of liver reserve function ICG-K at 6 months after surgery.

3. Liver reserve function ICG-K at 12 months after surgery. [12 months]

   The level of liver reserve function ICG-K at 12 months after surgery.

4. Liver reserve function ICG-K at 24 months after surgery. [24 months]

   The level of liver reserve function ICG-K at 24 months after surgery.

5. Liver reserve function ICG-R 15 at 3 months after surgery. [3 months]

   The level of liver reserve function ICG-R 15 at 3 months after surgery.

6. Liver reserve function ICG-R 15 at 6 months after surgery. [6 months]

   The level of liver reserve function ICG-R 15 at 6 months after surgery.

7. Liver reserve function ICG-R 15 at 12 months after surgery. [12 months]

   The level of liver reserve function ICG-R 15 at 12 months after surgery.

8. Liver reserve function ICG-R 15 at 24 months after surgery. [24 months]

   The level of liver reserve function ICG-R 15 at 24 months after surgery.

9. Liver reserve function ICG-T/2 at 3 months after surgery. [3 months]

   The level of liver reserve function ICG-T/2 at 3 months after surgery.

10. Liver reserve function ICG-T/2 at 6 months after surgery. [6 months]

    The level of liver reserve function ICG-T/2 at 6 months after surgery.

11. Liver reserve function ICG-T/2 at 12 months after surgery. [12 months]

    The level of liver reserve function ICG-T/2 at 12 months after surgery.

12. Liver reserve function ICG-T/2 at 24 months after surgery. [24 months]

    The level of liver reserve function ICG-T/2 at 24 months after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Medical College of Yangzhou University	Yangzhou	Jiangsu	China	225001

Sponsors and Collaborators

• Yangzhou University

Investigators

• Study Chair: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guo-Qing Jiang, Clinical Professor, Yangzhou University
• ClinicalTrials.gov Identifier: NCT05325437
• Other Study ID Numbers: YZUC-007
• First Posted: Apr 13, 2022
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guo-Qing Jiang, Clinical Professor, Yangzhou University: Cirrhosis; Splenectomy; Azygoportal disconnection; Laparoscopy; Liver Reserve Function
• Additional relevant MeSH terms: Liver Cirrhosis; Hypertension, Portal; Fibrosis

Study Results

No Results Posted as of Apr 13, 2022