Transparent Cap-assisted Endoscopic Sclerotherapy

Shanghai Zhongshan Hospital120 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Esophageal Varices

Interventions

assistance of a transparent capPROCEDURE

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

without a transparent capPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 76 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

rebleeding rate

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 Outcomes

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.

Time frame: From date of randomization until 1 month after randomization

mortality rate

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

time consumption of the procedure

Time frame: From the beginning of the endoscopic injection until the end of the procedure.

occurrence rate of bleeding during the procedure

Bleeding was defined as visible errhysis seen from gastroscopy

Time frame: From the beginning of the endoscopic injection, until the end of the procedure.

Data from ClinicalTrials.gov

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