Islets of Langerhans TransplantationTOPPERNCT05287737
Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation
An observational study of Islets of Langerhans Transplantation and Pancreatitis, Chronic, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Islets of Langerhans Transplantation, Pancreatitis, Chronic, Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jun 2022to Mar 2047
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred for TPIAT or who have underwent TPIAT since 2014.
Who may be able to join
- 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.
Who cannot join
- Known malignancies of the pancreas
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
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.
- Keywords
- total pancreatectomy, autologous islet transplantation, TPIAT, beta-cell function, c-peptide
- Medical subject headings
- Pancreatitis, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Referred for Total pancreatectomy with islet autotransplantation | Followed up for up for 15 years after TPIAT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic islet function
AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT)
Measured: Up to 15 years
Secondary outcomes (17)
Pancreatic islet function
Maximum C-peptide concentration during MMTT
Measured: Up to 15 years
Pancreatic islet function
Difference in basal and maximum C-peptide concentration during MMTT
Measured: Up to 15 years
Glycemic control
Time below range, time in range, time above range as determined by flash glucose monitoring (FGM) or continuous glucose measurement (CGM)
Measured: Up to 15 years
Glycemic control
Standard deviation determined by FGM or CGM
Measured: Up to 15 years
Glycemic control
HbA1c as determined in the blood and estimated by FGM or CGM
Measured: Up to 15 years
Glycemic control
Insulin requirements (IU/kg/day)
Measured: Up to 15 years
Quality of life
assessed by MOS Short Form 36 (SF-36) questionnaire
Measured: Up to 15 years
Quality of life
assessed by EQ-5D questionnaire
Measured: Up to 15 years
Diabetes-related stress
assessed by Problem Areas in Diabetes (PAID) questionnaire
Measured: Up to 15 years
Exocrine pancreatic insufficiency
assessed by Pancreas Exocrine Insufficiency Questionnaire (PEI-Q)
Measured: Up to 15 years
Pancreas-related pain
assessed by COMPAT-SF questionnaire
Measured: Up to 15 years
Pancreas-related pain
assessed by Izbicki questionnaire
Measured: Up to 15 years
Pain perception and central sensitization
assessed by Quantitative Sensory Testing
Measured: Baseline, MOS 6
Opioid usage
Morphine Milligram equivalents
Measured: Up to 15 years
Frequency of surgical complications
Early (<3 months) or late (>3 months)
Measured: Up to 15 years
Frequency of complications attributed to islet transplantation
Measured: Up to 15 years
Histological examination pancreas
Degree of fibrosis, acinar cell atrophy, inflammation and nesidioblastosis
Measured: After biopsy during islet isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start21 Jun 2022
- Primary completionMar 2047 (estimated)
- Study completionMar 2047 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Islets of Langerhans TransplantationStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eelco JP de Koning, Leiden University Medical Center
- Investigators
- Prof. Eelco de Koning, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287737
- Sponsor's protocol ID
- NL74838.058.21
- Acronym
- TOPPER
- Status last verified
- Jun 2024
- First submitted
- 1 Mar 2022
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation
- ClinicalTrials.gov ID
- NCT05287737
- Acronym / sponsor ID
- TOPPER / NL74838.058.21
- Keywords
- total pancreatectomy, autologous islet transplantation, TPIAT, beta-cell function, c-peptide
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- Mar 2047 (estimated)
- Study completion
- Mar 2047 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Referred for Total pancreatectomy with islet autotransplantation | – | –Followed up for up for 15 years after TPIAT. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred for TPIAT or who have underwent TPIAT since 2014.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Known malignancies of the pancreas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pancreatic islet function
Time frame: Up to 15 years
AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT)
17 secondary outcomes
Pancreatic islet function
Time frame: Up to 15 years
Pancreatic islet function
Time frame: Up to 15 years
Glycemic control
Time frame: Up to 15 years
Glycemic control
Time frame: Up to 15 years
Glycemic control
Time frame: Up to 15 years
Glycemic control
Time frame: Up to 15 years
Quality of life
Time frame: Up to 15 years
Quality of life
Time frame: Up to 15 years
Diabetes-related stress
Time frame: Up to 15 years
Exocrine pancreatic insufficiency
Time frame: Up to 15 years
Pancreas-related pain
Time frame: Up to 15 years
Pancreas-related pain
Time frame: Up to 15 years
Pain perception and central sensitization
Time frame: Baseline, MOS 6
Opioid usage
Time frame: Up to 15 years
Frequency of surgical complications
Time frame: Up to 15 years
Frequency of complications attributed to islet transplantation
Time frame: Up to 15 years
Histological examination pancreas
Time frame: After biopsy during islet isolation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Eelco de Koning principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Islets of Langerhans Transplantation and Pancreatitis, Chronic, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic islet function (time frame: Up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.