Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis

NACompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Chronic PancreatitisDiabetes MellitusIslet Cell Transplantation
Interventions
PROCEDURE

Intrahepatic islets and islets in the omental pouch

Patients with islet harvest of \>5000 islet equivalents per kg body weight will be randomized in a 1:1 ratio to 4000 IEq/kg delivered via intraportal route and the remainder implanted into a constructed omental pouch.

PROCEDURE

Intrahepatic islets alone

This is the standard of care procedure. Patients with islet harvest of \>5000 islet equivalents per kg body weight will be randomized in a 1:1 ratio to all islets autotransplanted intrahepatically via the intraportal route.

OTHER

Normal Volunteers

These individuals will undergo metabolic testing as well as islet cell function testing.

Trial Locations (1)

55455

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER

NCT03779139 - Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis | Biotech Hunter | Biotech Hunter