Transparent Cap-assisted Endoscopic Sclerotherapy

Fudan University

Status: Completed

Conditions: Esophageal Varices

Treatments: Procedure: assistance of a transparent cap; Procedure: without a transparent cap

Study type: Interventional

Funder types: Other

Identifiers

NCT02361593

CAP-VARICE

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Cap group

Experimental group

Description:

Patients will receive endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices with assistance of a transparent cap in front of gastroscopy.

Treatment:

Procedure: assistance of a transparent cap

Control group

Active Comparator group

Description:

Patients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved).

Treatment:

Procedure: without a transparent cap