Early Gastric Cancer or Gastric Adenoma
Conditions
Keywords
Endoscopic submucosal dissection, early gastric cancer, pain relief, intravenous dexamethasone, present pain intensity
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.
Interventions
Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including dexamethasone was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study. At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.
Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous normal saline as placebo immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including placebo was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study. At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactHyuk Lee, MD
Outcome results
None listed