An interventional study of assistance of a transparent cap and without a transparent cap in Esophageal Varices, sponsored by Shanghai Zhongshan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2017-01-16.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.
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.
169 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.
This study's enrollment of 120 is above the median of 104 across 109 interventional studies indexed under Esophageal and Gastric Varices.
Browse Esophageal and Gastric Varices studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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Exclusion Criteria:
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
Patients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved).
Procedure: without a transparent cap
Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.
Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.
rebleeding rate
Rebleeding was defined as melena or hematemasis
Time frame: From date of randomization until the date of first rebleeding episode, assessed up to 1 month
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.
Time frame: 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.
Time frame: From date of randomization until the date of death, assessed up to 1 month
time consumption of the procedure
Time frame: 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
Time frame: From the beginning of the endoscopic injection, until the end of the procedure.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Esophageal and Gastric Varices→
Shanghai Zhongshan Hospital