NCT05551832招募中3 期
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Marginal ulcer incidence
研究概览
简要总结
This research is to determine which medication, Esmesol (PPI) or Placebo works best at reducing the chance that a patient will get an marginal ulcer after pancreaticoduodenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test
排除标准
- •Subject allergic to ESMESOL Patient receiving antifungal (i.e. ketoconazole or itraconazole) Hepatic insufficiency History of Crohns disease History of Zollinger-Ellison disease Patient received an investigational drug within 30 days of enrollment Previous Gastric Surgery HX
研究组 & 干预措施
Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Placebo Comparator
Placebo beginning day of hospital discharge following PPPD for 6 months
干预措施: Arm I (Placebo), (Drug)
Esmesol 40mg after PPPD for 6 months
Experimental
Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months
干预措施: Arm II (ESMESOL) (Drug)
结局指标
主要结局
Marginal ulcer incidence
时间窗: Time Frame: during first 6 months after surgery
Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers
次要结局
- QOL(Time Frame: during first 6 months after surgery)
研究者
Joon Seong Park
professor
Gangnam Severance Hospital
研究点 (1)
Loading locations...
相似试验
终止
3 期
Nexium Study To Suppress Nausea During ChemotherapyNauseaNCT00206440Baylor Breast Care Center43
Unknown
4 期
Study of Long-Term Use of Proton-Pump-Inhibitors in General PracticeGastroesophageal RefluxdiseaseUlcerDyspepsiaNCT00363701Glostrup University Hospital, Copenhagen150
已完成
3 期
Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using Esomeprazole Plus CelecoxibArthritisBleeding UlcerNCT00365313Chinese University of Hong Kong273
已完成
4 期
Intravenous Proton Pump Inhibitor for Peptic Ulcer BleedingPeptic Ulcer HemorrhageNCT00731601Lotung Poh-Ai Hospital120
已完成
4 期
Importance of Cytokines in Peptic Ulcer Disease: Implications for TreatmentPeptic UlcerNCT00534443University of Athens150