Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection

Not Applicable

• Conditions: Early Gastric Cancer or Gastric Adenoma
• Interventions: Drug: intravenous normal saline; Drug: intravenous dexamethasone

• Registration Number: NCT02037399
• Lead Sponsor: Yonsei University

Brief Summary

Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-14
• Last Update Submitted: 2014-01-14
• Study First Posted: 2014-01-15
• Last Update Posted: 2014-01-15
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 20 years of age or older
• pathologically diagnosed gastric adenoma or cancer that was eligible for ESD
• patients who gave written informed consent from patients or responsible family members.

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Exclusion Criteria

• patients who take pain killer within 48 hours or regularly at enrollment
• confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease
• multiple gastric lesions for ESD
• history of gastric surgery at enrollment
• severe underlying disease including infection, cardiopulmonary disease, and diabetes.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous normal saline	intravenous normal saline	To receive normal saline as placebo intravenous immediately after ESD
intravenous dexamethasone	intravenous dexamethasone	To receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD

Primary Outcome Measures

Name	Time	Method
present pain intensity (PPI)	at 6 hours after ESD	The primary outcomes of this study was present pain intensity (PPI) measured at 6 hours after ESD. The reason for adopting 6- hour PPI as primary endpoint was due to maximized pain at 6 hours after ESD in our pilot study.

Trial Locations

Locations (1)

Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of