DRKS00015765尚未招募3 期
Endoscopic versus conservative management in the treatment of postoperative pancreatic fistula after distal pancreatectomy (Endo-POPF)– A randomized controlled pilot trial - Endo-POPF
Heidelberger Stiftung Chirurgie0 个研究点目标入组 40 人开始时间: 2018年10月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •Patients with (persistent) biochemical leak/POPF following DP, fulfilling one of the following criteria: a) If abdominal drain is placed intraoperatively: Persistent drainage of amylase-rich fluid (according to the updated ISGPS definition) on or after POD 8 or b) If no abdominal drain is placed intraoperatively: Application of percutaneous drainage system due to POPF on or after POD 8 with drainage of amylase-rich fluid (according to the updated ISGPS definition) ongoing after the first 24 hours; =18 years of age; Written informed consent; Ability of subject to understand character and individual consequences of the clinical trial
排除标准
- •Anatomical situation which makes duodenoscopy impossible/difficult; American Society of Anesthesiologists (ASA) score >III; Pregnancy or lactation; Understanding or language problems; Inability to comply with study and/or follow-up procedures; Known allergy or intolerability to contrast agents; Any condition which could result in an undue risk for the patient in the opinion of the investigator
研究者
相似试验
尚未招募
3 期
Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancreatic necRosis (CONDOR trial): a prospective randomised controlled trialSymptomatic strerile organized pancreatic necrosis after acute necrotizing pancreatitis1001796910017998NL-OMON32422Academisch Medisch Centrum58
进行中（未招募）
1 期
Intensive endoscopic therapy compared with standard endoscopic therapy for newly diagnosed benign strictures in the esophagus that developed after esophageal resectioBenign esophagogastric anastomotic strictures after esophagectomyMedDRA version: 20.0Level: LLTClassification code 10030199Term: Oesophageal strictureSystem Organ Class: 100000004856MedDRA version: 20.0Level: LLTClassification code 10015449Term: Esophageal strictureSystem Organ Class: 100000004856MedDRA version: 20.0Level: PTClassification code 10030215Term: OesophagectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10015460Term: EsophagectomySystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2016-001853-41-NLAcademic Medical Center89
暂停
不适用
Intensive endoscopic therapy versus standard treatment for untreated benign esophageal strictures resulting from excessive scar tissue formation after surgeryBenign esophageal stricturesAnastomotic stricturesEsophagectomyEndoscopic dilationEndoscopic incisionBenigne slokdarmstenosenNaadstenosenSlokdarmresectieEndoscopische dilatatieEndoscopische incisieNL-OMON29569Academic Medical Center89
已完成
3 期
Intensive endoscopic therapy versus conventional treatment for untreated benign anastomotic strictures after esophagectomy: a pilot and randomized controlled trialbenign esophageal anastomotic stricturepostsurgical esophageal stricture1001800810017998NL-OMON42848Academisch Medisch Centrum15
招募中
不适用
Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancReatic necrosis (CONDOR trial): a prospective randomised controlled trial.Acute necrotizing pancreatitis.NL-OMON22846Academic Medical Center (AMC), Department of Gastroenterology58