Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation

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

• Registration Number: NCT05287737
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-18
• Study Start: 2022-06-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2047-03
• Study Completion: 2047-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pancreatic islet function	Up to 15 years	AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT)

Secondary Outcome Measures

Name	Time	Method
Pancreatic islet function	Up to 15 years	Difference in basal and maximum C-peptide concentration during MMTT
Glycemic control	Up to 15 years	Insulin requirements (IU/kg/day)
Frequency of surgical complications	Up to 15 years	Early (\<3 months) or late (\>3 months)
Histological examination pancreas	After biopsy during islet isolation	Degree of fibrosis, acinar cell atrophy, inflammation and nesidioblastosis
Quality of life	Up to 15 years	assessed by EQ-5D questionnaire
Opioid usage	Up to 15 years	Morphine Milligram equivalents
Pancreas-related pain	Up to 15 years	assessed by Izbicki questionnaire
Pain perception and central sensitization	Baseline, MOS 6	assessed by Quantitative Sensory Testing
Frequency of complications attributed to islet transplantation	Up to 15 years
Diabetes-related stress	Up to 15 years	assessed by Problem Areas in Diabetes (PAID) questionnaire
Exocrine pancreatic insufficiency	Up to 15 years	assessed by Pancreas Exocrine Insufficiency Questionnaire (PEI-Q)

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands