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Enrolling by Invitation

NCT Number: NCT05287737

Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation

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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pancreatic islet function

    Time frame: Up to 15 years

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

Secondary outcomes

  1. Pancreatic islet function

    Time frame: Up to 15 years

    Maximum C-peptide concentration during MMTT

  2. Pancreatic islet function

    Time frame: Up to 15 years

    Difference in basal and maximum C-peptide concentration during MMTT

  3. Glycemic control

    Time frame: Up to 15 years

    Time below range, time in range, time above range as determined by flash glucose monitoring (FGM) or continuous glucose measurement (CGM)

  4. Glycemic control

    Time frame: Up to 15 years

    Standard deviation determined by FGM or CGM

  5. Glycemic control

    Time frame: Up to 15 years

    HbA1c as determined in the blood and estimated by FGM or CGM

  6. Glycemic control

    Time frame: Up to 15 years

    Insulin requirements (IU/kg/day)

  7. Quality of life

    Time frame: Up to 15 years

    assessed by MOS Short Form 36 (SF-36) questionnaire

  8. Quality of life

    Time frame: Up to 15 years

    assessed by EQ-5D questionnaire

  9. Diabetes-related stress

    Time frame: Up to 15 years

    assessed by Problem Areas in Diabetes (PAID) questionnaire

  10. Exocrine pancreatic insufficiency

    Time frame: Up to 15 years

    assessed by Pancreas Exocrine Insufficiency Questionnaire (PEI-Q)

  11. Pancreas-related pain

    Time frame: Up to 15 years

    assessed by COMPAT-SF questionnaire

  12. Pancreas-related pain

    Time frame: Up to 15 years

    assessed by Izbicki questionnaire

  13. Pain perception and central sensitization

    Time frame: Baseline, MOS 6

    assessed by Quantitative Sensory Testing

  14. Opioid usage

    Time frame: Up to 15 years

    Morphine Milligram equivalents

  15. Frequency of surgical complications

    Time frame: Up to 15 years

    Early (<3 months) or late (>3 months)

  16. Frequency of complications attributed to islet transplantation

    Time frame: Up to 15 years

  17. Histological examination pancreas

    Time frame: After biopsy during islet isolation

    Degree of fibrosis, acinar cell atrophy, inflammation and nesidioblastosis

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: TOPPER

Important dates

Study start
2022
Primary completion
2047
Study completion
2047
First posted
Mar 18, 2022
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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