Esophageal Varices
Conditions
Keywords
endoscopic sclerotherapy, esophageal varices, transparent cap
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.
Interventions
PROCEDUREassistance of a transparent cap
Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.
PROCEDUREwithout a transparent cap
Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rebleeding rate | From date of randomization until the date of first rebleeding episode, assessed up to 1 month | Rebleeding was defined as melena or hematemasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence rate of complications | From date of randomization until 1 month after randomization | 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. |
| mortality rate | From date of randomization until the date of death, assessed up to 1 month | Patients will be followed up for 1 month and all-cause death will be recorded. |
| 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 | From the beginning of the endoscopic injection, until the end of the procedure. | Bleeding was defined as visible errhysis seen from gastroscopy |
Countries
China
Outcome results
None listed