Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients

NCT ID: NCT07205471

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-24

Study Completion Date

2028-09-24

Brief Summary

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In this study,the researchers compared the changes in immune function-related indicators in patients with liver cirrhosis following laparoscopic partial splenectomy,to determine whether this surgical intervention can enhance postoperative immune function and thereby improve patient outcomes.

Detailed Description

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Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Eligible patients were randomly assigned in a 1:1 ratio to two groups: the laparoscopic splenectomy group and the laparoscopic partial splenectomy group, using a computer-generated randomization sequence. Following comprehensive preoperative preparation, all surgeries were performed by the same surgical team. The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.

Postoperatively, all patients received standardized care from the same nursing team, followed by a uniform treatment protocol that included pharmacotherapy, additional therapeutic interventions, and follow-up assessments. Throughout the treatment period, monitoring was performed preoperatively and at 7 days, 1, 3, 6, and 12 months postoperatively. The parameters monitored included routine blood tests, liver function, coagulation profile, immune function, and hemodynamics of the portal vein, proper hepatic artery, and splenic vein.Additionally, indocyanine green (ICG) clearance tests were performed at 3, 6, and 12 months to assess liver function.

Conditions

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Cirrhoses, Liver Splenectomy; Status Partial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic splenectomy

Patients in this arm undergo the standard laparoscopic splenectomy procedure, which serves as the active comparator. The entire spleen is removed after careful dissection and ligation of the splenic hilum.

Group Type NO_INTERVENTION

No interventions assigned to this group

laparoscopic partial splenectomy

The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.

Group Type EXPERIMENTAL

Laparoscopic Partial Splenectomy

Intervention Type PROCEDURE

The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.

Interventions

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Laparoscopic Partial Splenectomy

The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Jiangsu People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guo-Qing Jiang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guo-Qing Jiang

Role: STUDY_CHAIR

Clinical Medical College, Yangzhou University

Locations

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Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guo-Qing Jiang

Role: CONTACT

+8651487373382

Dou-Sheng Bai

Role: CONTACT

+8651487373382

Facility Contacts

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Guo-Qing Jiang, MS

Role: primary

86-514-87373372

Dou-Sheng Bai, MD

Role: backup

86-514-87373375

Other Identifiers

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YZUC-014

Identifier Type: -

Identifier Source: org_study_id

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