Clinical Trial: Transparent Cap-assisted Endoscopic Sclerotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome: rebleeding rate [ Time Frame: From date of randomization until the date of first rebleeding episode, assessed up to 1 month ]

Rebleeding was defined as melena or hematemasis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • incidence rate of complications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From the beginning of the endoscopic injection until the end of the procedure. ]
  • occurrence rate of bleeding during the procedure [ Time Frame: From the beginning of the endoscopic injection, until the end of the procedure. ]
    Bleeding was defined as visible errhysis seen from gastroscopy


Original Secondary Outcome: Same as current

Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: January 24, 2015
Date Started: April 2015
Date Completion:
Last Updated: January 13, 2017
Last Verified: January 2017