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临床试验/NCT05287737
NCT05287737Enrolling By Invitation不适用

Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月21日最近更新:
适应症

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

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

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eelco JP de Koning

Prof. Eelco de Koning

Leiden University Medical Center

研究点 (1)

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