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Completed

NCT Number: NCT02361593

Transparent Cap-assisted Endoscopic Sclerotherapy

The aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.

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Key information

Conditions

Esophageal Varices Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 0086200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

assistance of a transparent cap

Procedure

Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.

without a transparent cap

Procedure

Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. time consumption of the procedure

    Time frame: From the beginning of the endoscopic injection until the end of the procedure.

  4. 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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2015
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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