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Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

NCT01922492 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-11-20

No results posted yet for this study

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.

Conditions

  • Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

Interventions

PROCEDURE

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.

DRUG

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.

Sponsors & Collaborators

  • Ministry of Health & Welfare, Korea

    collaborator OTHER_GOV

  • Novartis

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Kyong Soo Park · Seoul National University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922492 on ClinicalTrials.gov