Clinical outcome after total pancreatectomy with islet autotransplantation

Clinical outcome after total pancreatectomy with islet autotransplantation - TOPPER

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55170

Enrollment

100

Registered

2021-06-22

Start date

2022-06-21

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic pancreatitis, islet transplantation chronic pancreatitis, islet transplantation

Interventions

none

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age >= 16 years - Referred for TPIAT or TPIAT performed since 2014 - Active and/or passive understanding of the Dutch language - Willingness to wear a flash glucose measurement or continuous glucose measurement device at least in the first 3 months after TPIAT and for 2 weeks before yearly study visits

Exclusion criteria

Exclusion criteria: - Known malignancies of the pancreas

Design outcomes

Primary

Measure	Time frame
AUC0-120min C-peptide (nmol/L/120min) during a mixed meal tolerance test (MMTT).	—

Secondary

Measure	Time frame
- Maximum C-peptide concentration (nmol/L) during the MMTT - Difference in basal and maximum C-peptide (nmol/L) during the MMTT - Time below target range range (<3.9), in target range (3.9-10) and hyperglycemic range (>10.0) determined by flash glucose measurement (FGM) or continuous glucose measurement (CGM) - Standard deviation determined by flash glucose measurement (FGM) or continuous glucose measurement (CGM) during the follow-up period - HbA1c in blood and estimated by FGM or CGM - Insulin requirements (assessed as the average IU/kg/day during the last week) - Quality of life assessed by MOS Short Form 36 (SF-36) and EQ-5D - Diabetes related stress assessed by Problem Areas in Diabetes Questionnaire (PAID) - Exocrine pancreatic insufficiency assessed by Pancreas Exocrine Insufficiency Questionaire (PEI-Q) - Pancreas-related pain assessed by COMPAT-SF questionnaire and Izbicki questionnaire - Use of opioids assessed in Morphine Milligram Equivalents - Degree of change in pancreatic tissue assessed by histologic examination for fibrosis, acinar cell atrophy, inflammation and nesidioblastosis, characterized as absent or rare, moderate, numerous. - Frequency of surgical complications (early <3 months after TPIAT, late >3 months after TPIAT). - Frequency of complications attributed to islet transplantation. - Patient characteristics	—

Measure

Time frame

- Maximum C-peptide concentration (nmol/L) during the MMTT - Difference in basal and maximum C-peptide (nmol/L) during the MMTT - Time below target range range (<3.9), in target range (3.9-10) and hyperglycemic range (>10.0) determined by flash glucose measurement (FGM) or continuous glucose measurement (CGM) - Standard deviation determined by flash glucose measurement (FGM) or continuous glucose measurement (CGM) during the follow-up period - HbA1c in blood and estimated by FGM or CGM - Insulin requirements (assessed as the average IU/kg/day during the last week) - Quality of life assessed by MOS Short Form 36 (SF-36) and EQ-5D - Diabetes related stress assessed by Problem Areas in Diabetes Questionnaire (PAID) - Exocrine pancreatic insufficiency assessed by Pancreas Exocrine Insufficiency Questionaire (PEI-Q) - Pancreas-related pain assessed by COMPAT-SF questionnaire and Izbicki questionnaire - Use of opioids assessed in Morphine Milligram Equivalents - Degree of change in pancreatic tissue assessed by histologic examination for fibrosis, acinar cell atrophy, inflammation and nesidioblastosis, characterized as absent or rare, moderate, numerous. - Frequency of surgical complications (early <3 months after TPIAT, late >3 months after TPIAT). - Frequency of complications attributed to islet transplantation. - Patient characteristics

—

Countries

Netherlands

Contacts

Public ContactWEME de Vos

Leids Universitair Medisch Centrum

w.e.m.e.de_vos@lumc.nl071 5262085

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 27, 2026