Transparent Cap-assisted Endoscopic Sclerotherapy

January 13, 2017 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

Transparent Cap-assisted Endoscopic Sclerotherapy(Lauromacrogol Injection) in Esophageal Varices: a Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endoscopic procedures now play a great role in management of esophagogastric varices. Endoscopic variceal ligation(EVL) was recommended as first line therapy for primary and secondary prophylaxis in patients with esophageal varices. Previous studies have showed a superiority of EVL over endoscopic injection of sclerotherapy(EIS), mainly because of lower occurrence rate of complications. Procedure related complications were related to total amount of lauromacrogol, number of treatment and expertise of the endoscopists. Transparent cap has already been reported to assist in other endoscopic procedures, such as biopsy of Barret esophagus or endoscopic submucosal dissection. Accuracy and vision were improved with the help of transparent cap in the front of endoscopy. We have tried transparent cap-assisted sclerotherapy in some patients with in our hospital. Now a randomized controlled trial was conducted to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapy in management of esophageal varices.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 0086200032
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cap group
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
Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.
Active Comparator: Control group
Patients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved).
Procedure: without a transparent cap
Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rebleeding rate
Time Frame: From date of randomization until the date of first rebleeding episode, assessed up to 1 month
Rebleeding was defined as melena or hematemasis
From date of randomization until the date of first rebleeding episode, assessed up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence rate of complications
Time Frame: From date of randomization until 1 month after randomization
Participants will be followed for up to 1 month starting from the date of enrollment.Complications associated with endoscopic treatments include transient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain.
From date of randomization until 1 month after randomization
mortality rate
Time Frame: From date of randomization until the date of death, assessed up to 1 month
Patients will be followed up for 1 month and all-cause death will be recorded.
From date of randomization until the date of death, assessed up to 1 month
time consumption of the procedure
Time Frame: From the beginning of the endoscopic injection until the end of the procedure.
From the beginning of the endoscopic injection until the end of the procedure.
occurrence rate of bleeding during the procedure
Time Frame: From the beginning of the endoscopic injection, until the end of the procedure.
Bleeding was defined as visible errhysis seen from gastroscopy
From the beginning of the endoscopic injection, until the end of the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Director: Shiyao CHEN, M.D., Zhongshan hospital, Shanghai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 24, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 12, 2015

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAP-VARICE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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