Transparent Cap-assisted Endoscopic Sclerotherapy

Esophageal Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361593
• Other study ID #: CAP-VARICE
• Status: Completed
• Phase: N/A
• First received: January 24, 2015
• Last updated: January 13, 2017
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices

Intervention

Procedure:
• assistance of a transparent cap
Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.
• without a transparent cap
Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rebleeding rate	Rebleeding was defined as melena or hematemasis	From date of randomization until the date of first rebleeding episode, assessed up to 1 month
Secondary	incidence rate of complications	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.	From date of randomization until 1 month after randomization
Secondary	mortality rate	Patients will be followed up for 1 month and all-cause death will be recorded.	From date of randomization until the date of death, assessed up to 1 month
Secondary	time consumption of the procedure		From the beginning of the endoscopic injection until the end of the procedure.
Secondary	occurrence rate of bleeding during the procedure	Bleeding was defined as visible errhysis seen from gastroscopy	From the beginning of the endoscopic injection, until the end of the procedure.