NCT04801290

Brief Summary

This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School. By collecting and analyzing clinical data as well as blood samples, the overall aim is to optimize TIPS therapy (e.g. specify selection criteria).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Aug 2019Dec 2027

Study Start

First participant enrolled

August 29, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

8.3 years

First QC Date

February 26, 2021

Last Update Submit

September 10, 2025

Conditions

Decompensated Liver Cirrhosis

Keywords

Portal hypertensionTIPSRefractory ascitesVariceal bleedingLiver cirrhosis

Outcome Measures

Primary Outcomes (4)

  • Mortality

    Patients who die within 1 year

    1 year

  • Occurrence of (Minimal) Hepatic Encephalopathy

    Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT)

    1 year

  • Change in Nutritional Status

    Nutritional Status will be measured by hand grip strength (dynamometer) in kg

    1 year

  • Change in Quality of Life

    Using the questionnaire short-form 36 (SF36) (Score range 0-100, higher scores correspond to better quality of life)

    1 year

Secondary Outcomes (5)

  • Change in inflammatory markers (e.g. cytokine)

    12 months

  • Change in different metabolites using mass spectroscopy (metabolomics measurements)

    12 months

  • Analysis of cellular immunity by collection of peripheral blood mononuclear cells (PBMCs)

    12 months

  • Analysis of stool samples

    12 months

  • Measurement of portal hypertension

    6 months

Study Arms (1)

TIPS insertion

Procedure: TIPS insertion

Interventions

TIPS insertionPROCEDURE

Patients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent.

TIPS insertion

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with decompensated liver cirrhosis and an indication for TIPS placement at Hannover Medical School.

You may qualify if:

  • Liver cirrhosis
  • Indication for TIPS insertion
  • Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School
  • Informed consent

You may not qualify if:

  • Pregnancy or Lactation
  • Age \<18 years
  • Lack of Informed consent
  • Symptomatic anemia with Hb \<7g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Related Publications (3)

  • Sandmann L, Egge JFM, Tiede A, Ehrenbauer AF, Kabelitz MA, Rieland H, Mauz JB, Meyer BC, Wedemeyer H, Weissenborn K, Maasoumy B. Plasma Ammonia Levels Predict Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Placement. United European Gastroenterol J. 2025 Sep;13(7):1171-1183. doi: 10.1002/ueg2.70095. Epub 2025 Aug 9.

    PMID: 40782353DERIVED

  • Kabelitz MA, Gairing SJ, Tiede A, Schleicher EM, Ahl LG, Wagner L, Zucker-Reimann F, Rieland H, Mauz JB, Weinmann-Menke J, Meyer BC, Pitton MB, Wedemeyer H, Galle PR, Sandmann L, Maasoumy B, Labenz C. Impact of Frailty on the Prognosis of Patients With Liver Cirrhosis Undergoing Insertion of a TIPS. Aliment Pharmacol Ther. 2026 Jan;63(1):109-118. doi: 10.1111/apt.70315. Epub 2025 Aug 1.

    PMID: 40751304DERIVED

  • Ehrenbauer AF, Schneider H, Stockhoff L, Tiede A, Lorenz C, Dirks M, Witt J, Gabriel MM, Wedemeyer H, Hinrichs JB, Weissenborn K, Maasoumy B. Predicting overt hepatic encephalopathy after TIPS: Value of three minimal hepatic encephalopathy tests. JHEP Rep. 2023 Jun 28;5(9):100829. doi: 10.1016/j.jhepr.2023.100829. eCollection 2023 Sep.

    PMID: 37600959DERIVED

MeSH Terms

Conditions

Hypertension, PortalAscitesLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Study Officials

  • Benjamin Maasoumy, PD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Maasoumy, PD

CONTACT

+49 511 532-6529Maasoumy.Benjamin@mha-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 17, 2021

Study Start

August 29, 2019

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations

DE(1)