Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation

NCT05287737 | Enrolling By Invitation DMC

• 1 other identifier: NL74838.058.21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Islets of Langerhans Transplantation; Pancreatitis, Chronic; Diabetes Mellitus

Keywords

total pancreatectomy; autologous islet transplantation; TPIAT; beta-cell function; c-peptide

Outcome Measures

Primary Outcomes (1)

• Pancreatic islet function

  AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT)

  Up to 15 years

Secondary Outcomes (17)

• Pancreatic islet function

  Up to 15 years

• Pancreatic islet function

  Up to 15 years

• Glycemic control

  Up to 15 years

• Glycemic control

  Up to 15 years

• Glycemic control

  Up to 15 years

Study Arms (1)

Referred for Total pancreatectomy with islet autotransplantation

Followed up for up for 15 years after TPIAT.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for TPIAT or who have underwent TPIAT since 2014.

You may qualify if:

• 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.

You may not qualify if:

• Known malignancies of the pancreas

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Prof. Eelco de Koning

  LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Eelco de Koning

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 18, 2022
• Study Start: June 21, 2022
• Primary Completion (Estimated): March 1, 2047
• Study Completion (Estimated): March 1, 2047
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

NL (1)