Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 20, 2022

Primary Completion Date

February 20, 2028

Study Completion Date

February 20, 2030

Conditions
Adenocarcinoma of the PancreasAdenocarcinoma of the DuodenumAmpullary Adenocarcinoma
Interventions
PROCEDURE

total pancreatectomy

"The total pancreatectomy will be performed in two steps: The pancreatectomy will begin by a standard pancreaticoduodenectomy procedure.~The section margin will be sent for intraoperative histological analysis to confirm the absence of invasion of the left remnant pancreas.~When absence of tumor invasion is confirmed and the high-risk of postoperative pancreatic fistula is validated intraoperatively, the extended left distal pancreatectomy will be performed, with splenic preservation when possible.~Then, the left side of the pancreas will be resected and cooled (4-6°) in the preservation solution and shipped to Lille Biotherapy platform to perform islet isolation and purification. The reconstruction after total pancreatectomy will be done as usually performed by center expert surgeon."

BIOLOGICAL

intraportal islet autotransplantation

The final islet preparation will be cultured and shipped 48 hours after total pancreatectomy from the Lille laboratory to the surgical center, and finally transplanted into the patient through a venous catheter placed in the portal trunk (91% of the total islet mass) and at the same time, a small fraction of the isolated islet (5% of the total islet mass) will be transplanted into the forearm muscle.

Trial Locations (1)

59037

RECRUITING

Hop Claude Huriez Chu Lille, Lille

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

University Hospital, Lille

OTHER