NCT02119884

Brief Summary

The purpose of the study is to find patients's response to terlipressin and octreotide during hepatic venous pressure gradient measurement by observing portal and systemic hemodynamics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

April 17, 2014

Last Update Submit

June 9, 2016

Conditions

Gastric and Esophageal Varices

Keywords

Gastric and Esophageal VaricesHepatic Venous Pressure GradientTerlipressinOctreotide

Outcome Measures

Primary Outcomes (1)

  • Fluctuation of HVPG

    Terlipressin or octreotide will be administered to a patient once after the bottom line of his/her HVPG is determined. We observe the changes of HVPG after administration to find out the effects of terlipressin or octreotide on portal hemodynamics.

    10min, 20min and 30min after administration

Secondary Outcomes (1)

  • Response Rate

    10min, 20min and 30min after administration

Other Outcomes (2)

  • Fluctuation of MAP and HR

    10min, 20min and 30min after administration

  • Incidence rate of complications

    Participants will be followed for up to 24h starting from the moment of administration

Study Arms (2)

Terlipressin group

EXPERIMENTAL

Patients receive terlipressin 2 mg IV bolus

Drug: Terlipressin

High Dose Octreotide group

ACTIVE COMPARATOR

Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg

Drug: Octreotide

Interventions

TerlipressinDRUG

Patients in the terlipressin group receive a single IV injection of 2 mg of terlipressin and a continuous IV infusion of normal saline.

Also known as: HanWei
Terlipressin group
OctreotideDRUG

Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.

Also known as: ShanNing
High Dose Octreotide group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric and Esophageal Varices have been confirmed through endoscopy
  • Liver Biopsy, CT or MRI indicates cirrhosis
  • Patients who experienced variceal bleeding

You may not qualify if:

  • The patients who are beyond the range from 18 to 80 years old
  • The patients with unstable vital signs
  • The patients with spontaneous peritonitis or other severe infections
  • The patients with hepatorenal syndrome or renal inadequacy
  • The patients with uncontrolled hepatic encephalopathy
  • Pregnant and lactating women
  • The patients who had contraindications for terlipressin or octreotide
  • The patients who refuse to take part in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Li B, Chen J, Zhang CQ, Wang GC, Hu JH, Luo JJ, Zhang W, Wei YC, Zeng XQ, Chen SY. The pharmacodynamic effect of terlipressin versus high-dose octreotide in reducing hepatic venous pressure gradient: a randomized controlled trial. Ann Transl Med. 2021 May;9(9):793. doi: 10.21037/atm-20-6774.

    PMID: 34268406DERIVED

MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

TerlipressinOctreotide

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsPeptides, CyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Shiyao Chen, Professor

    Shanghai Zhongshan Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of Gastroenterology

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 22, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 13, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)