Overview

This trial is active, not recruiting.

Condition partial pancreatectomy due to benign pancreatic neoplasm
Treatments autologous islet transplantation, oral anti-diabetic drugs
Sponsor Seoul National University Hospital
Collaborator Ministry of Health & Welfare, Korea
Start date May 2008
End date December 2017
Trial size 28 participants
Trial identifier NCT01922492, SHUH_AIT_1

Summary

- Effects of autologous islet transplantation were compared to those of oral anti-diabetic drugs after distal pancreatectomy.

- The primary interest is a insulin-secretory function after the surgery in two intervention groups.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Autologous islet transplantation arm: autologous islet transplantation
autologous islet transplantation
Islet was isolated from the normal part of resected pancreas with modified Ricordi method. After purification, the islets were infused into the liver through percutaneous transhepatic portal vein catheterization.
(Active Comparator)
Metformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter)
oral anti-diabetic drugs
Metformin on the diagnosis of postoperative diabetes mellitus. Starting dose of 500mg per day and dose adjustment as needed to control blood glucose. Vildagliptin added on the insufficient glycemic control with monotherapy. Starting dose of 50mg per day and dose adjustment as needed to control blood glucose.

Primary Outcomes

Measure
Changes of insulin secretory function
time frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.

Secondary Outcomes

Measure
Changes of glucose tolerance
time frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Incidence of postoperative diabetes mellitus
time frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Changes of insulin resistance
time frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Adverse effects
time frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: - Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass Exclusion Criteria: - Prior history of diabetes mellitus - Patients whose fasting, post-load (75g OGTT) glucose or HbA1c level meet ADA diagnostic criteria - Patients who refused to participate the study

Additional Information

Official title Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.
Principal investigator Kyong Soo Park
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.