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Transparent Cap-assisted Endoscopic Sclerotherapy

Primary Purpose

Esophageal Varices

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
assistance of a transparent cap
without a transparent cap
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Varices focused on measuring endoscopic sclerotherapy, esophageal varices, transparent cap

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cap group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

rebleeding rate
Rebleeding was defined as melena or hematemasis

Secondary Outcome Measures

incidence rate of complications
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.
mortality rate
Patients will be followed up for 1 month and all-cause death will be recorded.
time consumption of the procedure
occurrence rate of bleeding during the procedure
Bleeding was defined as visible errhysis seen from gastroscopy

Full Information

First Posted
January 24, 2015
Last Updated
January 13, 2017
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02361593
Brief Title
Transparent Cap-assisted Endoscopic Sclerotherapy
Official Title
Transparent Cap-assisted Endoscopic Sclerotherapy(Lauromacrogol Injection) in Esophageal Varices: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices
Keywords
endoscopic sclerotherapy, esophageal varices, transparent cap

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cap group
Arm Type
Experimental
Arm Description
Patients will receive endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices with assistance of a transparent cap in front of gastroscopy.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved).
Intervention Type
Procedure
Intervention Name(s)
assistance of a transparent cap
Intervention Description
Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.
Intervention Type
Procedure
Intervention Name(s)
without a transparent cap
Intervention Description
Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.
Primary Outcome Measure Information:
Title
rebleeding rate
Description
Rebleeding was defined as melena or hematemasis
Time Frame
From date of randomization until the date of first rebleeding episode, assessed up to 1 month
Secondary Outcome Measure Information:
Title
incidence rate of complications
Description
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.
Time Frame
From date of randomization until 1 month after randomization
Title
mortality rate
Description
Patients will be followed up for 1 month and all-cause death will be recorded.
Time Frame
From date of randomization until the date of death, assessed up to 1 month
Title
time consumption of the procedure
Time Frame
From the beginning of the endoscopic injection until the end of the procedure.
Title
occurrence rate of bleeding during the procedure
Description
Bleeding was defined as visible errhysis seen from gastroscopy
Time Frame
From the beginning of the endoscopic injection, until the end of the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao CHEN, M.D.
Organizational Affiliation
Zhongshan Hospital, Shanghai
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
0086200032
Country
China

12. IPD Sharing Statement

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Transparent Cap-assisted Endoscopic Sclerotherapy

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