Long-term Efficacy and Safety of LSD Versus TIPS for Cirr... | NCT07490405

Studies
Long-term Efficacy and Safety of LSD Versus TIPS for Cirrhotic Portal Hypertension Bleeding and Hypersplenism

NCT07490405

Sponsor

Northern Jiangsu People's Hospital

Status

Not yet recruiting

Last Update Posted

May 18, 2026Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Liver Cirrhosis

Interventions

LSD
TIPS

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Mar 1, 2031Estimated

Completion Date

Apr 1, 2036Estimated

First Submitted Date

Mar 18, 2026

First Submission Date that Met QC Criteria

Mar 18, 2026

First Posted Date

Mar 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to compare two treatments for cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism: laparoscopic splenectomy and azygoportal disconnection (LSD) and transjugular intrahepatic portosystemic shunt (TIPS). It is a single-center, prospective trial. The primary outcome is the incidence of post-procedure hepatic encephalopathy. Secondary outcomes include changes in hepatic venous pressure gradient, portal and hepatic artery hemodynamics, liver function, renal function, complete blood count, immune function, hepatic reserve capacity, serological markers of liver fibrosis, re-bleeding rate, hepatocellular carcinoma incidence, recompensation incidence, overall survival, and bleeding-free survival. The study will provide high-level evidence for optimal treatment selection in this patient population.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Label	Type	Description	Intervention Names
LSD			Procedure: LSD
TIPS			Procedure: TIPS

Name	Type	Description	Arm Group Labels	Other Names
LSD	Procedure	laparoscopic splenectomy and azygoportal disconnection	LSD

Measure	Description	Time Frame
overall survival rate	overall survival rate	5-year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of cirrhotic portal hypertension.
Endoscopic examination confirmed the presence of severe esophagogastric varices accompanied by acute bleeding. Rebleeding occurred after endoscopic variceal ligation (EVL) treatment..
Presence of hypersplenism causing significant thrombocytopenia and/or leukopenia.
Liver function Child-Pugh class A or B (score 7-9).
Age 18-75 years.
Patient provides written informed consent.

Exclusion Criteria:

Liver function Child-Pugh class C (score ≥10), or Model for End-Stage Liver Disease (MELD) score >18.
Severe right heart failure or pulmonary hypertension.
Uncontrolled systemic infection or sepsis.
Polycystic liver disease, portal cavernous transformation, or portal vein thrombosis (affecting procedure or shunt creation).
Advanced hepatocellular carcinoma (beyond Milan criteria) or other uncontrolled malignancies.
Severe hepatic encephalopathy (West-Haven grade III-IV) unresponsive to medication.
Severe contrast agent allergy (affecting TIPS procedure).
Pregnancy or lactation.
Any severe non-hepatic disease with a life expectancy <1 year.
Recent gastric and duodenal ulcers.
Inability to comply with follow-up or provide informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Guoqing Jiang, MD	Contact	18051060606		jgqing2003@hotmail.com

Facility	Status	City	State	ZIP	Country	Contacts
Northern Jiangsu People's Hospital		Yangzhou	Jiangsu	225000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008103	Liver Cirrhosis

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Intervention Browse Module

MeSH Terms

ID	Term
D008238	Lysergic Acid Diethylamide
D019168	Portasystemic Shunt, Transjugular Intrahepatic

Ancestor Terms

ID	Term
D008237	Lysergic Acid
D004873	Ergolines
D004876	Ergot Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided