Transparent Cap-assisted Endoscopic Sclerotherapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Varices

Intervention / Treatment
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* Procedure: assistance of a transparent cap
* Procedure: without a transparent cap


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cap group<br>Patients will receive endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices with assistance of a transparent cap in front of gastroscopy. | Procedure: assistance of a transparent cap<br>* Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.<br>|
| Active Comparator: Control group<br>Patients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved). | Procedure: without a transparent cap<br>* Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| time consumption of the procedure |  | From the beginning of the endoscopic injection until the end of the procedure. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic sclerotherapy, esophageal varices, transparent cap