Cirrhosis, LiverELSDLNCT05325437
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients
A study testing Laparoscopic splenectomy and azygoportal disconnection in people with Cirrhosis, Liver and Splenectomy; Status, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Splenectomy; Status, Portal Hypertension
- What is being tested?
- Laparoscopic splenectomy and azygoportal disconnection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001
Guo-Qing Jiang, MD, 86-514-87373372, jgqing2003@hotmail.com
Dou-Sheng Bai, MD, 86-514-87373372, bdsno1@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Cirrhosis, Liver, Splenectomy; Status, Portal Hypertension
- Being tested
- Laparoscopic splenectomy and azygoportal disconnection
- Keywords
- Cirrhosis, Splenectomy, Azygoportal disconnection, Laparoscopy, Liver Reserve Function
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic splenectomy and azygoportal disconnectionProcedure or surgery
The laparoscopic splenectomy and azygoportal disconnection was performed by the same surgical team.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Laparoscopic splenectomy and azygoportal disconnection Receives: Procedure: Laparoscopic splenectomy and azygoportal disconnection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver reserve function ICG-K at 3 months after surgery.
The level of liver reserve function ICG-K at 3 months after surgery.
Measured: 3 months
Liver reserve function ICG-K at 6 months after surgery.
The level of liver reserve function ICG-K at 6 months after surgery.
Measured: 6 months
Liver reserve function ICG-K at 12 months after surgery.
The level of liver reserve function ICG-K at 12 months after surgery.
Measured: 12 months
Liver reserve function ICG-K at 24 months after surgery.
The level of liver reserve function ICG-K at 24 months after surgery.
Measured: 24 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 24 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Mar 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
- Investigators
- Guo-Qing Jiang, MD, Study chair, Clinical Medical College of Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325437
- Sponsor's protocol ID
- YZUC-007
- Acronym
- ELSDL
- Status last verified
- May 2025
- First submitted
- 18 Mar 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding S, Zhou LX, Gao TM, Shi ZB, Chen C, Jin SJ, Zhang C, Zhou BH, Bai DS, Jiang GQ. Effects of laparoscopic splenectomy and azygoportal disconnection on liver reserve function for cirrhosis patients: a 1-year prospective study. Surg Endosc. 2026 Aug 7. doi: 10.1007/s00464-026-13274-7. Online ahead of print.
PubMed 42566007