Clinical trial NCT02361593: Transparent Cap-assisted Endoscopic Sclerotherapy
Official title: Transparent Cap-assisted Endoscopic Sclerotherapy(Lauromacrogol Injection) in Esophageal Varices: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Varices
Keywords: endoscopic sclerotherapy, esophageal varices, transparent cap
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: rebleeding rate
timeFrame: From date of randomization until the date of first rebleeding episode, assessed up to 1 month
Secondary outcomes:
measure: incidence rate of complications
timeFrame: From date of randomization until 1 month after randomization
measure: mortality rate
timeFrame: From date of randomization until the date of death, assessed up to 1 month
measure: time consumption of the procedure
timeFrame: From the beginning of the endoscopic injection until the end of the procedure.
measure: occurrence rate of bleeding during the procedure
timeFrame: From the beginning of the endoscopic injection, until the end of the procedure.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Shanghai
name: Shiyao CHEN, M.D.
role: STUDY_DIRECTOR
References: