Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation (TOPPER)

Leiden University Medical Center (LUMC)

Status: Invitation-only

Conditions: Islets of Langerhans Transplantation; Diabetes Mellitus; Pancreatitis, Chronic

Study type: Observational

Funder types: Other

Identifiers

NCT05287737

NL74838.058.21

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Referred for Total pancreatectomy with islet autotransplantation

Description:

Followed up for up for 15 years after TPIAT.