2023-507773-17-00招募中2 期
Pancreatic head resection or total pancreatectomy with islet autotransplantation (IATx) in patients with periampullary cancer and high risk profile for the development of postoperative pancreatic fistula (POPF) - XandTX Trial
Technische Universitat Dresden1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年4月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Duration between surgery and the date of the decision "fit for adjuvant treatment" (postoperative day X)
研究概览
简要总结
To obtain first data on the treatment effect of primary total pancreatectomy with simultaneous autologous islet transplantation in patients with periampullary carcinoma and high-risk profile for the development of postoperative pancreatic fistulae (POPF).
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female patients ≥18 years
- •Suspicion of or confirmed diagnosis of periampullary cancer and indication for pylorus preserving pancreaticoduodenectomy (PPPD) or Whipple surgery
- •High risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreatic tissue and a pancreatic duct diameter <3mm (pre- and intraoperative confirmation)
- •Written informed consent after clarification
排除标准
- •Patients planned for an additional surgery besides the PPD or Whipple surgery
- •Simultaneous participation in another interventional clinical trial (up to 4 weeks before enrolment)
- •Addiction or other concomitant diseases, which prevent the participant from understanding and comprehending the scope, nature and potential consequences of the clinical trial
- •Pregnant or lactating women
- •Women of childbearing potential, except for women who meet at least one of the following criteria: a) Postmenopausal; b) Post-surgery (6 weeks after bilateral ovariectomy, bilateral salpingectomy with or without a hysterectomy); c) Negative pregnancy test (serum) and the willingness to regularly and correctly use a highly effective contraceptive method (Pearl Index <1%); d) Abstinence; e) Partner’s vasectomy
- •Any indication that the participant is unlikely to adhere to the protocol (i.e. lack of compliance)
- •Diagnosis of a second primary cancer
- •Previous organ- or tissue transplant
- •Known HIV infection (HIV antibody test)
- •Positivity for Anti-HCV, positive anti-HBsAg or anti-HBc
- •Insulin treated diabetes
- •Known hypersensitivity towards one of the substances under investigation or its components or substances of similar chemical structure
- •Individuals, who are dependent from the sponsor
- •Individuals of vulnerable groups, such as: a) Adults, who are unable to understand the nature, significance and scope of the clinical trial and who are unable to articulate their will accordingly; b)Individuals, who are unable to give consent; c) Individuals, who are institutionalized by court or official order ; d) Individuals listed under exclusion criteria 12 as well as inclusion criteria 1 and 4
结局指标
主要结局
Duration between surgery and the date of the decision "fit for adjuvant treatment" (postoperative day X)
Duration between surgery and the date of the decision "fit for adjuvant treatment" (postoperative day X)
次要结局
- Duration between surgery and the actual start of adjuvant therapy
- Perioperative morbidity and mortality
- Number and type of adverse events and serious adverse events
- Quality of life (post-surgery, EORTC QLQ-C30/Pan26)
- Metabolic outcome
- Oncological long term course (60 months)
研究者
Prof. Dr. med. Barbara Ludwig
Scientific
Technische Universitat Dresden
研究点 (1)
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