Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Islets of Langerhans Transplantation, Pancreatitis, Chronic, Diabetes Mellitus. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Pancreatic islet function [Time frame: Up to 15 years]
Secondary outcome measures (12)
- Pancreatic islet function [Time frame: Up to 15 years]
- Pancreatic islet function [Time frame: Up to 15 years]
- Glycemic control [Time frame: Up to 15 years]
- Glycemic control [Time frame: Up to 15 years]
- Glycemic control [Time frame: Up to 15 years]
- Glycemic control [Time frame: Up to 15 years]
- Quality of life [Time frame: Up to 15 years]
- Quality of life [Time frame: Up to 15 years]
- Diabetes-related stress [Time frame: Up to 15 years]
- Exocrine pancreatic insufficiency [Time frame: Up to 15 years]
- Pancreas-related pain [Time frame: Up to 15 years]
- Pancreas-related pain [Time frame: Up to 15 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Known malignancies of the pancreas
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Leiden University Medical Center — Leiden
Identifiers
NCT: NCT05287737 · NL74838.058.21