Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation

Diabetes Mellitus Clinical Trial

— TOPPER  

Official title:

Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05287737
• Other study ID #: NL74838.058.21
• Status: Enrolling by invitation
• Start date: June 21, 2022
• Est. completion date: March 2047

Study information

• Verified date: September 2022
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 2047
• Est. primary completion date: March 2047
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Islets of Langerhans Transplantation
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic islet function	AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT)	Up to 15 years
Secondary	Pancreatic islet function	Maximum C-peptide concentration during MMTT	Up to 15 years
Secondary	Pancreatic islet function	Difference in basal and maximum C-peptide concentration during MMTT	Up to 15 years
Secondary	Glycemic control	Time below range, time in range, time above range as determined by flash glucose monitoring (FGM) or continuous glucose measurement (CGM)	Up to 15 years
Secondary	Glycemic control	Standard deviation determined by FGM or CGM	Up to 15 years
Secondary	Glycemic control	HbA1c as determined in the blood and estimated by FGM or CGM	Up to 15 years
Secondary	Glycemic control	Insulin requirements (IU/kg/day)	Up to 15 years
Secondary	Quality of life	assessed by MOS Short Form 36 (SF-36) questionnaire	Up to 15 years
Secondary	Quality of life	assessed by EQ-5D questionnaire	Up to 15 years
Secondary	Diabetes-related stress	assessed by Problem Areas in Diabetes (PAID) questionnaire	Up to 15 years
Secondary	Exocrine pancreatic insufficiency	assessed by Pancreas Exocrine Insufficiency Questionnaire (PEI-Q)	Up to 15 years
Secondary	Pancreas-related pain	assessed by COMPAT-SF questionnaire	Up to 15 years
Secondary	Pancreas-related pain	assessed by Izbicki questionnaire	Up to 15 years
Secondary	Pain perception and central sensitization	assessed by Quantitative Sensory Testing	Baseline, MOS 6
Secondary	Opioid usage	Morphine Milligram equivalents	Up to 15 years
Secondary	Frequency of surgical complications	Early (<3 months) or late (>3 months)	Up to 15 years
Secondary	Frequency of complications attributed to islet transplantation		Up to 15 years
Secondary	Histological examination pancreas	Degree of fibrosis, acinar cell atrophy, inflammation and nesidioblastosis	After biopsy during islet isolation