注册号: Registration number: |
ChiCTR1900027644 |
最近更新日期: Date of Last Refreshed on: |
2019-11-22 |
注册时间: Date of Registration: |
2019-11-22 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
开腹清创灌洗术与小切口引流术在胰腺假性囊肿合并感染中的前瞻、随机、多中心对照研究 |
Public title: |
Prospective, randomized, multicenter controlled trial for open debridement and lavage and small incision drainage in the treatment of pancreatic pseudocyst complicated with infection |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
开腹清创灌洗术与小切口引流术在胰腺假性囊肿合并感染中的前瞻、随机、多中心对照研究 |
Scientific title: |
Prospective, randomized, multicenter controlled trial for open debridement and lavage and small incision drainage in the treatment of pancreatic pseudocyst complicated with infection |
研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
徐新建 |
研究负责人: |
徐新建 |
Applicant: |
Xinjian XU |
Study leader: |
Xinjian XU |
申请注册联系人电话: Applicant telephone: |
+86 18599025120 |
研究负责人电话: Study leader's telephone: |
+86 18599025120 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
krron@163.com |
研究负责人电子邮件: Study leader's E-mail: |
krron@163.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号 |
研究负责人通讯地址: |
新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号 |
Applicant address: |
137 Li-Yu-Shan Road, Urumqi, Xinjiang Uygur Autonomous Region, China |
Study leader's address: |
137 Li-Yu-Shan Road, Urumqi, Xinjiang Uygur Autonomous Region, China |
申请注册联系人邮政编码: Applicant postcode: |
830054 |
研究负责人邮政编码: Study leader's postcode: |
830054 |
申请人所在单位: |
新疆医科大学第一附属医院消化血管外科中心胰腺外科 |
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Applicant's institution: |
Department of Pancreatic Surgery, Center of digestive & vascular medicine, The First Affiliated Hospital of Xinjiang Medical University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
20180622-07 |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
新疆医科大学第一附属医院伦理委员会 |
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Name of the ethic committee: |
Ethics committee of the first affiliated hospital of xinjiang medical university |
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伦理委员会批准日期: Date of approved by ethic committee: |
2019-05-21 | ||
伦理委员会联系人: |
罗坤 |
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Contact Name of the ethic committee: |
Kun Luo |
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伦理委员会联系地址: |
新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号 |
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Contact Address of the ethic committee: |
137 Li-Yu-Shan Road, Urumqi, Xinjiang Uygur Autonomous Region, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
新疆医科大学第一附属医院消化血管外科中心胰腺外科 |
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Primary sponsor: |
Department of Pancreatic Surgery, Center of digestive & vascular medicine, The First Affiliated Hospital of Xinjiang Medical University |
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研究实施负责(组长)单位地址: |
新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号 |
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Primary sponsor's address: |
137 Li-Yu-Shan Road, Urumqi, Xinjiang Uygur Autonomous Region, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
self-finance |
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研究疾病: |
胰腺假性囊肿合并感染 |
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Target disease: |
Pancreatic pseudocyst with infection |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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研究目的: |
研究开腹微创外引流与传统外引流术的优缺点对比 |
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Objectives of Study: |
To compare the advantages and disadvantages of minimally invasive external drainage with traditional external drainage |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
1.获得受试者的知情同意书; 2.临床治愈已度过急性期,病情稳定后再次病情恶化,不能进食或体温高烧持续1周以上; 3.增强CT显示:腹腔内或胰周病灶出现“气泡征”; 4.排除肺部感染、导管感染、尿路感染等非胰腺引起的发热或病情恶化; 5.在手术前7天内,有足够的肝肾功能,合适的实验室指标(治疗后):中性粒细胞≥1500/mm3,PLT≥50×109/L,血清ALB≥28g/L。TBIL<2mg/dL,ALT、AST<5倍正常值上限值,Bun、Cr<1.5倍正常值上限值,INR<1.7或PT延长<4s。 |
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Inclusion criteria |
1. Obtain informed consent from the subject; 2. The clinical cure has passed the acute phase, and the condition deteriorates again after the condition is stable, and the patient cannot eat or the fever lasts for more than 1 week; 3. Enhanced CT showed "bubble sign" in intraperitoneal or peripancreatic lesions; 4. Exclude pulmonary infection, catheter infection, urinary tract infection and other non-pancreatic fever or deterioration; 5. Within 7 days before the operation, there was sufficient liver and kidney function, appropriate laboratory indicators (after treatment) : neutrophils >=1500/mm3, PLT>=50x10^9/L, and serum ALB>=28g/L. TBIL < 2mg/dL, ALT and AST < 5 times normal value, Bun and Cr < 1.5 times normal value, INR < 1.7 or PT extension < 4s. |
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排除标准: |
1.充血性心力衰竭>纽约心脏协会(NYHA)分级2级; 2.有无法控制的高血压; 3.有人类免疫缺陷病毒(HIV)感染病史; 4.肾衰竭或肾功能不足、需要进行血液或腹膜透析; 5.严重活动性临床感染(>2级,NCI-CTCAE版本4.0); 6.除外术前4周内出现上消化道出血或有明确消化道出血倾向; 7.怀孕中或正在哺乳的受试者; 8.开始试验前4周内有过大手术的患者或尚未从这类手术的副作用中恢复的患者; 9.诊断为胰腺肿瘤患者,如:囊腺瘤(既往3年前已治愈者可纳入)。 |
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Exclusion criteria: |
1.Congestive heart failure > New York heart association (NYHA) grade 2; 2. Uncontrolled high blood pressure; 3. A history of human immunodeficiency virus (HIV) infection; 4. Renal failure or insufficiency, requiring hemodialysis or peritoneal dialysis; 5. Severe active clinical infection (> level 2, nci-ctcae version 4.0); 6. Except for upper gastrointestinal bleeding or clear tendency of gastrointestinal bleeding within 4 weeks before surgery; 7. Subjects who are pregnant or breast-feeding; 8. Patients who had major surgery 4 weeks before the trial or who had not yet recovered from the side effects of such surgery; 9. Patients diagnosed with pancreatic neoplasms, such as cystadenoma (those who had been cured 3 years earlier could be included). |
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研究实施时间: Study execute time: |
从From2020-01-01至To 2022-12-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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