Clinical trial NCT05287737: Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation
Official title: Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Islets of Langerhans Transplantation
Pancreatitis, Chronic
Diabetes Mellitus
Keywords: total pancreatectomy
autologous islet transplantation
TPIAT
beta-cell function
c-peptide
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for TPIAT or who have underwent TPIAT since 2014.

Brief summary: 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.


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

Primary outcomes:
measure: Pancreatic islet function
timeFrame: Up to 15 years
Secondary outcomes:
measure: Pancreatic islet function
timeFrame: Up to 15 years
measure: Pancreatic islet function
timeFrame: Up to 15 years
measure: Glycemic control
timeFrame: Up to 15 years
measure: Glycemic control
timeFrame: Up to 15 years
measure: Glycemic control
timeFrame: Up to 15 years
measure: Glycemic control
timeFrame: Up to 15 years
measure: Quality of life
timeFrame: Up to 15 years
measure: Quality of life
timeFrame: Up to 15 years
measure: Diabetes-related stress
timeFrame: Up to 15 years
measure: Exocrine pancreatic insufficiency
timeFrame: Up to 15 years
measure: Pancreas-related pain
timeFrame: Up to 15 years
measure: Pancreas-related pain
timeFrame: Up to 15 years
measure: Pain perception and central sensitization
timeFrame: Baseline, MOS 6
measure: Opioid usage
timeFrame: Up to 15 years
measure: Frequency of surgical complications
timeFrame: Up to 15 years
measure: Frequency of complications attributed to islet transplantation
timeFrame: Up to 15 years
measure: Histological examination pancreas
timeFrame: After biopsy during islet isolation
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: LUMC
name: Prof. Eelco de Koning
role: PRINCIPAL_INVESTIGATOR
References: