NCT02361593

Transparent Cap-assisted Endoscopic Sclerotherapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Varices

Interventions

Type	Name	Description
PROCEDURE	assistance of a transparent cap	Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.
PROCEDURE	without a transparent cap	Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-05-01
• Completion: 2016-12-01
• First posted: 2015-02-12
• Last updated: 2017-01-16

Locations

1 site across 1 country: China