Pancreatic Cancer, Pancreatic Neoplasms, Periampullary Neoplasms
Conditions
Keywords
Total pancreatectomy, Islet autotransplantation, TPIAT, Postoperative pancreatic fistula, Pancreaticoduodenectomy
Brief summary
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.
Interventions
PROCEDURETotal Pancreatectomy with Islet Autotransplantation (TPIAT)
Participants will undergo total pancreatectomy with islet autotransplantation using either an open or robotic surgical approach. After removal of the pancreas, islets will be isolated from nontumorous pancreatic tissue and infused into the portal venous system according to established institutional protocols. The study will prospectively assess feasibility, perioperative safety, metabolic outcomes, and early oncologic outcomes through 12 months after surgery.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-arm feasibility study in which all enrolled participants undergo open or robotic total pancreatectomy with islet auto-transplantation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and older. * Patients with periampullary neoplasms requiring pancreaticoduodenectomy, including but not limited to: * Pancreatic adenocarcinoma * Distal bile duct adenocarcinoma * Duodenal adenocarcinoma * Leiomyosarcoma of the duodenum * Pancreatic neuroendocrine neoplasms * Ampullary adenoma * Duodenal gastrointestinal stromal tumor * High-risk intraductal papillary mucinous neoplasm according to Fukuoka criteria, specifically focal Intraductal Papillary Mucinous Neoplasm (IPMN) in the head of pancreas with high-risk stigmata or worrisome features on endoscopic ultrasound with fine-needle aspiration * Mucinous cystic neoplasm * Serous cystadenoma * Soft pancreatic gland and main pancreatic duct ≤2 mm at the neck of the pancreas based on preoperative imaging. * Adequate islet function with measurable C-peptide preoperatively to justify islet isolation and transplant.
Exclusion criteria
* Pregnancy. * Active alcohol or illicit drug use. * Poorly controlled psychiatric illness that limits ability to comply with care. * Pre-existing insulin-dependent diabetes with absent C-peptide. * Portal vein thrombosis or significant portal hypertension precluding islet infusion. * Contraindications to major surgery. * Body mass index greater than 35 kg/m².
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual accrual rate of participants who consent to and undergo planned TPIAT | From study opening through completion of enrollment, up to 36 months | Annual accrual rate, defined as the number of eligible participants per year who provide informed consent and proceed with the planned total pancreatectomy with islet autotransplantation procedure. The feasibility threshold is accrual of at least 3 participants per year. |
| Consent yield among eligible patients approached for participation | From study opening through completion of enrollment, up to 36 months | Consent yield, defined as the proportion of approached, eligible patients who provide informed consent and undergo planned total pancreatectomy with islet autotransplantation. The feasibility threshold is at least 5%, defined as at least 1 of the first 20 eligible patients approached consenting to and undergoing TPIAT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major postoperative complications within 90 days after surgery | Up to 90 days post surgery | Number and proportion of participants experiencing at least one major postoperative complication within 90 days after TPIAT. Complications will be graded according to the Clavien-Dindo classification. Major complications are defined as Clavien-Dindo Grade III-V. |
| Unplanned readmission within 90 days after surgery | Up to 90 days post surgery | Number and percentage of participants with at least one unplanned hospital readmission within 90 days after TPIAT. |
| Length of hospital stay | From date of surgery to date of discharge, assessed up to 90 days | Number of days from the date of TPIAT to hospital discharge. |
| Incidence of hypoglycemic events requiring hospitalization | Up to 12 months post surgery | Number and percentage of participants experiencing hypoglycemic events requiring hospitalization after TPIAT. |
| Incidence of endocrine pancreatic insufficiency | At 3, 6, and 12 months post surgery | Number and percentage of participants with endocrine pancreatic insufficiency after TPIAT, assessed using insulin requirement, fasting glucose, fasting C-peptide, and hemoglobin A1c. |
| Average Daily Insulin requirement (IU/kg/day) after TPIAT | At 3, 6, and 12 months post surgery | Average daily insulin requirement after TPIAT, assessed at postoperative months 3, 6, and 12. |
| Fasting glucose (percentage) after TPIAT | At 3, 6, and 12 months post surgery | Fasting glucose level measured after TPIAT |
| Fasting C-peptide (ng/mL) after TPIAT | At 3, 6, and 12 months after surgery | Fasting C-peptide level measured after TPIAT. |
| Hemoglobin A1c (percentage) after TPIAT | At 3, 6, and 12 months after surgery | Hemoglobin A1c measured after TPIAT. |
| Tumor recurrence within 1 year after surgery | Within 12 months after surgery | Number and proportion of participants with clinical, radiographic, or pathologic evidence of tumor recurrence within 1 year after TPIAT. |
Countries
United States
Contacts
CONTACTJin He, MD, PhD
CONTACTThomas McPhaul, MS
PRINCIPAL_INVESTIGATORJin He, MD
SKCCC Johns Hopkins Medical Institution
Outcome results
None listed