20 Participants NeededMy employer runs this trial

Total Pancreatectomy with Islet Autotransplantation for Pancreatic Cancer

TM
JH
TM
Overseen ByThomas McPhaul, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single-center, prospective, single-arm feasibility study evaluating whether adult patients with periampullary neoplasms who are at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy can be recruited and consented to undergo total pancreatectomy with islet autotransplantation as an alternative surgical approach. Feasibility will be assessed by annual accrual rate and consent yield among eligible patients approached. Participants who enroll will undergo open or robotic total pancreatectomy with islet autotransplantation. Perioperative safety, metabolic outcomes, and early oncologic outcomes will be collected prospectively through 12 months after surgery.

Who Is on the Research Team?

JH

Jin He, MD

Principal Investigator

SKCCC Johns Hopkins Medical Institution

Are You a Good Fit for This Trial?

This trial is for adults (18+) with certain pancreatic or nearby tumors, such as bile duct cancer, duodenal cancer, high-risk cysts, neuroendocrine tumors, and others who are at high risk of complications after standard pancreas surgery.

Inclusion Criteria

I am 18 years old or older.
I have duodenal adenocarcinoma.
I have a gastrointestinal stromal tumor in my duodenum.
See 10 more

Exclusion Criteria

Poorly controlled psychiatric illness that limits ability to comply with care
Body mass index greater than 35 kg/m²
Pregnancy
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Total Pancreatectomy with Islet Autotransplantation (TPIAT)

Trial Overview

The study tests total removal of the pancreas combined with islet autotransplantation—a procedure to help preserve insulin production—as an alternative surgical option. All participants receive this treatment and are followed for a year.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Total Pancreatectomy With Islet AutotransplantationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+