NCT05843877招募中3 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)
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
- 32
- 试验地点
- 1
- 主要终点
- Duration between surgery and time "fit for adjuvant treatment" (postoperative day X)
研究概览
简要总结
The primary objective of this clinical trial is to evaluate whether primary total pancreatectomy with simultaneous islet autotransplantation compared with pancreatic head resection (alone) can reduce perioperative morbidity and time to initiation of adjuvant therapy in patients with a high-risk constellation for pancreatic fistulas.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected or confirmed periampullary carcinoma (tumor) and indication for PPPD (pylorus-preserving pancreaticoduodenectomy) or Whipple surgery
- •high-risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreas and Pancreatic duct diameter < 3 mm (preoperative and intraoperative confirmation)
- •written informed consent of the participant after successful Informed consent
排除标准
- •patients on whom another procedure is to be performed simultaneously in addition to PPPD or Whipple surgery
- •confirmed other primary tumor
- •previous transplantation of an organ or tissue
- •known infection with HIV (HIV antibodies)
- •positive hepatitis C antibodies, positive hepatitis B surface antigens and hepatitis Bc antibodies
- •insulin-treated diabetes mellitus
- •history of hypersensitivity to any of the drugs used or their ingredients or to drugs with a similar chemical structure
- •concurrent participation in another clinical trial (incl. within the last 4 weeks prior to inclusion).
- •addiction or other medical conditions that do not allow the subject to understand the nature and not be able to appreciate the nature, scope and possible consequences of the trial
- •pregnant or breastfeeding women
- •women of childbearing age, except for women who meet the following criteria:
- •Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml)
- •Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy)
- •Regular and correct use of a contraceptive method with an failure rate < 1% per year
- •Sexual abstinence
- •Vasectomy of the partner
- •evidence that the patient is unlikely to comply with the protocol
研究组 & 干预措施
Experimental Therapy
Experimental
Total pancreatectomy with autologous islet cell transplantation
干预措施: Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy (Biological)
Standard Therapy
Other
Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
干预措施: Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) (Procedure)
结局指标
主要结局
Duration between surgery and time "fit for adjuvant treatment" (postoperative day X)
时间窗: From day of discharge until confirmed fitness for adjuvant treatment or 24 months, whichever came first
Time (days) between surgery and the date of certified fitness to begin adjuvant therapy, confirmed by an oncology consult, starting at day of discharge, than assessed at POD 90, POD 180, POD 365, 24 months
次要结局
- Rate of peri-operative morbidity/mortality acc. to Clavien-Dindo classification(After enrolment of the patient until 24 months after intervention)
- Comparison of actual start of adjuvant therapy in both arms(From POD 90 until actual start of therapy or 24 months whichever came first)
- Rate of (serious) adverse events(After randomization of the patient until 24 months after intervention)
- Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire(From date of screening until 24 months after intervention)
- Patient reported outcomes: Quality of life EORTC PAN26 questionnaire(From date of screening until 24 months after intervention)
- Comparison of metabolic outcome in both arms: glucagon(From date of screening until 24 months after intervention)
- Comparison of metabolic outcome in both arms: glycohemoglobin HbA1c(From date of screening until 24 months after intervention)
- Comparison of metabolic outcome in both arms: continuous glucose monitoring (CGM)(From date of screening until 24 months after intervention)
- Comparison of metabolic outcome in both arms: fructosamine(From date of screening until 24 months after intervention)
- Comparison of metabolic outcome in both arms: number of hypoglycemic events(From date of screening until 24 months after intervention)
- Comparison of metabolic outcome in both arms: severity of hypoglycemia(From date of screening until 24 months after intervention)
- Comparison of long-term oncological course (24 months) in both arms: recurrence(24 months after intervention)
- Comparison of metabolic outcome in both arms: C-peptide(From date of screening until 24 months after intervention)
- Comparison of metabolic outcome in both arms: insulin requirement(From date of screening until 24 months after intervention)
- Comparison of long-term oncological course (24 months) in both arms: tumor markers(24 months after intervention)
- Comparison of long-term oncological course (24 months) in both arms: occurence of metastases(24 months after intervention)
研究者
研究点 (1)
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