Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pancreatic islet function
研究概览
简要总结
A total pancreatectomy with islet autotransplantation (TPIAT) can be performed for a number of benign indications, such as chronic pancreatitis. In the current standard of treatment, after non-invasive, endoscopic efforts and other surgical options to relieve the pain, a total pancreatectomy is a last resort option. The pancreas is surgically removed during this procedure. Afterwards, the patient will have diabetes mellitus that is usually difficult to control with dependency on exogenous insulin administration. In TPIAT, a total pancreatectomy is followed by islet isolation from the resected pancreas and autotransplantation of these islets into the liver by means of a transhepatic intraportal islet infusion. Depending on the number and quality of islets, TPIAT may lead to full islet function so that no anti-hyperglycemic therapy is necessary or to partial islet function necessitating anti-hyperglycemic therapy. This can be only oral agents with reasonable islet function or complex insulin regimes with poor islet function. However, even with partial Islet function, glycemic control is easier with a lower risk of hypoglycemic events and diabetes-related complications, and an overall improvement of quality of life.
In this cohort, the endocrine function and glycemic variability will be monitored over time (up to 15 years). Additionally, pain scores, pain perception and central sensitization, quality of life, exocrine pancreatic insufficiency and diabetes-related stress will be monitored.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for TPIAT or TPIAT performed since 2014
- •Active and/or passive understanding of the Dutch language
- •Willingness to wear a FGM or CGM device at least in the 2 weeks prior to TPIAT, first 3 months after TPIAT and for 2 weeks before yearly clinical visits.
排除标准
- •Known malignancies of the pancreas
结局指标
主要结局
Pancreatic islet function
时间窗: Up to 15 years
AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT)
次要结局
- Pancreatic islet function(Up to 15 years)
- Glycemic control(Up to 15 years)
- Frequency of surgical complications(Up to 15 years)
- Histological examination pancreas(After biopsy during islet isolation)
- Quality of life(Up to 15 years)
- Opioid usage(Up to 15 years)
- Pancreas-related pain(Up to 15 years)
- Pain perception and central sensitization(Baseline, MOS 6)
- Frequency of complications attributed to islet transplantation(Up to 15 years)
- Diabetes-related stress(Up to 15 years)
- Exocrine pancreatic insufficiency(Up to 15 years)
研究者
Eelco JP de Koning
Prof. Eelco de Koning
Leiden University Medical Center
