Transparent Cap-assisted Endoscopic Sclerotherapy

Not Applicable

Completed

• Conditions: Esophageal Varices

• Registration Number: NCT02361593
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2015-01-24
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-12
• Study Start: 2015-04
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
rebleeding rate	From date of randomization until the date of first rebleeding episode, assessed up to 1 month	Rebleeding was defined as melena or hematemasis

Secondary Outcome Measures

Name	Time	Method
occurrence rate of bleeding during the procedure	From the beginning of the endoscopic injection, until the end of the procedure.	Bleeding was defined as visible errhysis seen from gastroscopy
incidence rate of complications	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.
mortality rate	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.
time consumption of the procedure	From the beginning of the endoscopic injection until the end of the procedure.

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China