Transparent Cap-assisted Endoscopic Sclerotherapy(Lauromacrogol Injection) in Esophageal Varices: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- rebleeding rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 76 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
rebleeding rate
Time Frame: From date of randomization until the date of first rebleeding episode, assessed up to 1 month
Rebleeding was defined as melena or hematemasis
Secondary Outcomes
- occurrence rate of bleeding during the procedure(From the beginning of the endoscopic injection, until the end of the procedure.)
- incidence rate of complications(From date of randomization until 1 month after randomization)
- mortality rate(From date of randomization until the date of death, assessed up to 1 month)
- time consumption of the procedure(From the beginning of the endoscopic injection until the end of the procedure.)
Investigators
Shiyao Chen
Professor
Shanghai Zhongshan Hospital