Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-21

Study Completion Date

2047-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Islets of Langerhans Transplantation Pancreatitis, Chronic Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Referred for Total pancreatectomy with islet autotransplantation

Followed up for up for 15 years after TPIAT.

No interventions assigned to this group

Eligibility Criteria

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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.