The goal of this study is to monitor the long-term islet function after total pancreatectomy with islet autotransplantation.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Endocrine gland therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
AUC0-120min C-peptide (nmol/L/120min) during a mixed meal tolerance test
(MMTT).
Secondary outcome
- 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
- Quantitative Sensory Testing
- 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
Background summary
A total pancreatectomy with islet auto transplantation (TPIAT) can be performed
for a number of indications, such as idiopathic chronic pancreatitis, pancreas
divisum with recurrent pancreatitis, hereditary pancreatitis and trauma.
The most common indication is chronic pancreatitis which is a condition
characterized by recurring inflammation of the pancreas. The condition is
characterised by severe abdominal pain, it progresses and leads to permanent
damage of the pancreas affecting the exocrine and endocrine function. The
endocrine function is responsible for glucose regulation by secretion of the
hormones insulin and glucagon by the islets of Langerhans.
In the current standard of treatment, after non-invasive and endoscopic efforts
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 and the
patient will be dependent on exogenous insulin administration.
TPIAT is a total pancreatectomy that 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.
Study objective
The goal of this study is to monitor the long-term islet function after total
pancreatectomy with islet autotransplantation.
Study design
This study is an observational cohort study. All patients will receive the same
treatment (TPIAT) as if they would not participate in this study. Data are
collected on endocrine function at baseline and postoperatively in the first 3
months and then yearly up to 15 years. Parallel to those visits, questionnaires
will be conducted to evaluate pain, quality of life, stress and exocrine
pancreatic insufficiency. Data on complications after total pancreactomy and
islet autotransplantation will be collected. Quantitative Sensory Testing will
be conducted at baseline and 6 months after TPIAT.
Study burden and risks
For this study, participants will have 2 extra visits to the hospital for
quantitative snesory testing. This is a noninvasive test where the participants
may experience pain shortly. They will also fill out questionnaires
periodically. These questionnaires are not burdensome.
This is a low-risk study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
- Known malignancies of the pancreas
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74838.058.21 |