ACTRN12623001112651招募中Unknown
HEPATA- HEreditary Pancreatitis and Auto-islet transplant Trials Australia: Effect on analgesic requirement and glycemic control.
Central Adelaide Local Health Network0 个研究点目标入组 24 人开始时间: 2023年10月25日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 75 Years（—）
- 性别
- All
入选标准
- •Individuals must have molecular genotype-confirmed Hereditary Pancreatitis (PRSS-1,SPINK-1,CFTR,CTRC ) AND symptoms of Pancreatitis fulfilling the Minnesota Criteria for TP-IAT
- •The Minnesota criteria:
- •(1) Diagnosis of pancreatitis with the features of chronic abdominal pain of > 6 months duration with evidence of; i), identified gene mutation (PRSS1, SPINK1, CRTR, CTRC); ii), pancreatic calcification on CT scan; iii), > 4/9 Endoscopic Ultrasound Criteria (EUS); iv), histological confirmed diagnosis of CP.
- •(2) At least one of the following: daily narcotic dependence, pain resulting in impaired quality of life which may include: inability to attend school, recurrent hospitalisations and inability to participate in usual, age appropriate activities.
- •(3) Complete evaluation with no reversible cause of pancreatitis present or untreated.
- •(4) Failure to respond to maximal medical therapy and endoscopic therapy.
- •(5) Adequate islet cell function (non-diabetic or C-peptide positive).
排除标准
- •Absolute contraindications: suspicion of pancreatic carcinoma complicating chronic pancreatitis, presence of intrapapillary mucinous neoplasia (IPMNs), ongoing significant alcohol consumption. Relative Contraindications: anticipated poor islet yields due to: age (>75 yrs), previous pancreatic surgery and insulin dependency, increased surgical risks due to hostile abdomen (previous abdominal catastrophies) and surgical comorbidities (morbid obesity, ongoing smoking) and pregnancy. Patients with acute pancreatitis with other readily identifiable non-genetic causes such as alcohol, gall stone, auto-immune pancreatitis, hyper-triglyceridaemia and anatomic variants e.g. pancreas divisum and without a family history that is suggestive of an inherited disorder.
研究者
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