Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Adenoma

Stomach Neoplasms

Inflammation

Gastritis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Lipid Regulating Agents

All Drugs and Chemicals

Simvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Study1 (only H. pylori infected patients) Arm1: All patients undergo H. pylori eradication therapy after 2 weeks from the endoscopic submucosal dissection. In this arm2, all patients take statins for 6 months. Then, follow-up endoscopy for gastric biopsy and CLO test will be performed after 6.5 months from the endoscopic submucosal dissection.

Study2 (only H. pylori non-infected patients) Arm1: In this arm2, all patients start taking statins after 2 weeks from the endoscopic submucosal dissection. Follow-up endoscopy for gastric biopsy will be performed after 6.5 months from the endoscopic submucosal dissection.

Arm1: Statin

Study1 (only H. pylori infected patients) Arm2: All patients undergo H. pylori eradication therapy after 2 weeks from the endoscopic submucosal dissection. In this arm2, all patients take placebos for 6 months. Then, follow-up endoscopy for gastric biopsy and CLO test will be performed after 6.5 months from the endoscopic submucosal dissection.

Study2 (only H. pylori non-infected patients) Arm2: In this arm2, all patients start taking placebos after 2 weeks from the endoscopic submucosal dissection. Follow-up endoscopy for gastric biopsy will be performed after 6.5 months from the endoscopic submucosal dissection.

Arm2: Placebo

Statins are commonly used as cholesterol-lowering medications and have shown effectiveness in the primary and secondary prevention of heart attack and stroke. In addition, several recent studies of human cancer cell lines and animal tumor models indicate that statins may have chemopreventive properties through the arresting of cell-cycle progression. The chemopreventive effect of statins was demonstrated in some kind of human tumors including colorectal cancer. In addition, recent one large epidemiologic study showed that statins decreased risk of gastric cancer. On the other hands, it has been well known that Helicobacter pylori infection induces gastric atrophy and intestinal metaplasia, which are premalignant lesions of gastric cancer. Progression of these premalignant lesions could be limited by H. pylori eradication. In addition, a recent double blind randomization study revealed that simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate. Therefore, investigators conjecture that statins may have an adjuvant role for inhibition of gastric carcinogenesis. investigators aim to evaluate the role of statins in gastric carcinogenesis by observing the changes of gastric inflammation under statins.

Role of Statin on the Gastric Inflammation in Patients at High Risk of Gastric Cancer

patients with high-risk OLGA stages will be assessed by histologic examinations

Yonsei University

Pain

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Sucralfate

Dexamethasone acetate

Lansoprazole

Dexlansoprazole

Proton Pump Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

To receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD

To receive normal saline as placebo intravenous immediately after ESD

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.

intravenous dexamethasone

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.

intravenous normal saline

Hyuk Lee, MD

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.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Role of Statin on the Gastric Inflammation in Patients at High Risk of Gastric Cancer	NCT01813994	Early Gastric C...	Arm1: Statin Arm2: Placebo	20 Years - 70 Years	Yonsei University
Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection	NCT02037399	Early Gastric C...	intravenous dex... intravenous nor...	20 Years - 80 Years	Yonsei University

Spots Global Cancer Trial Database for early gastric cancer or gastric adenoma