About this trial
This is a single-center, prospective, single-arm study evaluating the safety and feasibility of total pancreatectomy with islet autotransplantation (TPIAT) in carefully selected adult patients with periampullary neoplasms who are considered at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy. Eligible patients will undergo open or robotic TPIAT as part of the patient's surgical management. Perioperative outcomes, postoperative complications, metabolic outcomes, and early oncologic outcomes will be collected prospectively as part of routine clinical care and analyzed to assess the safety and feasibility of this approach.
Eligibility criteria
Qualifiers
Adults aged 18 and older.
Distal bile duct adenocarcinoma
Duodenal adenocarcinoma
Leiomyosarcoma of the duodenum
Disqualifiers
Pregnancy
Active alcohol or illicit drug use
Poorly controlled psychiatric illness that limits compliance with care
Pre-existing insulin-dependent diabetes with absent C-peptide
Trial design
Treatments tested in this trial
- Total Pancreatectomy with Islet Autotransplantation (TPIAT)
Treatment groups
Locations
Sponsors and collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor