Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT02361593
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2015-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transparent Cap-assisted Endoscopic Sclerotherapy
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
Transparent Cap-assisted Endoscopic Sclerotherapy(Lauromacrogol Injection) in Esophageal Varices: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: