NCT02361593

Brief Summary

The aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

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

First Submitted

Initial submission to the registry

January 24, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

January 24, 2015

Last Update Submit

January 13, 2017

Conditions

Esophageal Varices

Keywords

endoscopic sclerotherapy, esophageal varices, transparent cap

Outcome Measures

Primary Outcomes (1)

  • rebleeding rate

    Rebleeding was defined as melena or hematemasis

    From date of randomization until the date of first rebleeding episode, assessed up to 1 month

Secondary Outcomes (4)

  • incidence rate of complications

    From date of randomization until 1 month after randomization

  • mortality rate

    From date of randomization until the date of death, assessed up to 1 month

  • time consumption of the procedure

    From the beginning of the endoscopic injection until the end of the procedure.

  • occurrence rate of bleeding during the procedure

    From the beginning of the endoscopic injection, until the end of the procedure.

Study Arms (2)

Cap group

EXPERIMENTAL

Patients will receive endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices with assistance of a transparent cap in front of gastroscopy.

Procedure: assistance of a transparent cap

Control group

ACTIVE COMPARATOR

Patients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved).

Procedure: without a transparent cap

Interventions

assistance of a transparent capPROCEDURE

Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.

Cap group
without a transparent capPROCEDURE

Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.

Control group

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presented to our hospital with esophageal varices diagnosed by gastroscopy, with or without gastric varices.
  • The age of the patients range from 18 to 80 years old.

You may not qualify if:

  • Patients who have contraindications for lauromacrogol therapy or transparent cap.
  • Patients who have no previous upper gastrointestinal bleeding history.
  • Patients who have fecal disease that could greatly impact survival, such as uremia, advanced cancer or respiratory failure, et al.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 0086200032, China

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Shiyao CHEN, M.D.

    Zhongshan Hospital, Shanghai

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2015

First Posted

February 12, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

CN(1)