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Completed

NCT Number: NCT02730533

The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal lesions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability to understand and the willingness to sign a written informed consent document.
  • Female or male aged ≥18 years.
  • Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy.

Exclusion criteria

  • Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
  • The ASA classification of physical status ≥ 4 as judged by the investigator.
  • Severe hepatic disease or renal disease
  • Ability to understand and the willingness to sign a written informed consent document.
  • Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
  • Haemorrhagic disorder.
  • Patients who had a history of gastrectomy or a recurrent lesion.
  • Known or suspected hypersensitivity to any component of any PPI .
  • Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
  • Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
  • Known or suspected alcohol, drug or medication abuse.
  • Any condition associated with poor compliance as judged by the investigator.
  • Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
  • Involvement in the planning and conduct of the study. Previous enrollment in the present study.

Treatment and study plan

Esomeprazole

Drug

Proton pump inhibitor

No PPI treatment

Drug

No PPI treatment before ESD procedure

Primary outcomes

  1. The total bleeding rate according to grading of intraoperative bleeding during ESD procedure

    Time frame: 1 day

    ≥grade 1 means bleeding

Secondary outcomes

  1. The frequency of coagrasper usage which reflects grade of major bleeding

    Time frame: 1 day

  2. Post-ESD ulcer quality as indicated in description

    Time frame: 1 day

    Ulcer base quality will be evaluated base on the grading of clean, with minor trace of coagulation, base with extensive coagulation.

  3. Intra-procedure injury to muscularis propria including perforation.

    Time frame: 1 day

    Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation.

  4. Mean haemoglobin reduction between intervention and control group.

    Time frame: 1 day

  5. Delayed bleeding rate as indicated by haematemesis and melaena

    Time frame: 30 days

  6. The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD: an Endoscopist-blinded Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2016
Registry last updated
Jul 21, 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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