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Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors

StatusRecruiting
PhaseNot applicable
Started2026-09-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
Enrollment reduced 33% 30 → 20 participants
See other at-risk trials from Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Amendment history

2026-09-01
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v5
Recruitment opened
Primary endpoint(s) modified1 to 2 entries
WasIncidence of Postoperative Complications
NowAnnual accrual rate of participants who consent to and undergo planned TPIAT, Consent yield among eligible patients approached for participation
Enrollment reduced: 30 → 20 participants
Primary completion moved earlier: 2031-02-01 → 2031-01-01
Completion moved earlier: 2031-02-01 → 2031-01-01
Start dateestimated 2026-08-01→confirmed 2026-09-01
Study sites0→1
Eligibility criteria+270 characters
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 Leio [...] ms Ampullary adenoma Duodenal gastrointestinal stromal tumor (GIST) High-risk intraductal papillary mucinous neoplasm according to Fukuoka criteria, specifically focal Intraductal Papillary Mucinous Neoplasm (IPMN) asin perthe Fukuokahead criteriaof pancreas with high-risk stigmata or worrisome features on endoscopic ultrasound with fine-needle aspiration M [...] [...]
Secondary endpoints1 to 10 entries
Incidence of major postoperative complications within 90 days after surgery Unplanned readmission within 90 days after surgery Length of Hospitalhospital Staystay Incidence of hypoglycemic events requiring hospitalization Incidence of endocrine pancreatic insufficiency Average Daily Insulin requirement (IU/kg/day) after TPIAT Fasting glucose (percentage) after TPIAT Fasting C-peptide (ng/mL) after TPIAT Hemoglobin A1c (percentage) after TPIAT Tumor recur [...]
2026-06-26
Study Status v4
Start date2026-06-01→2026-08-01
2026-05-07
Study Status v3
Start date2026-05-01→2026-06-01
2026-04-14
Study Status v2
Start date2026-04-01→2026-05-01
2026-02-24
Study Status v1
Start date2026-02-01→2026-04-01
2026-01-14
Original filing
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.
Trial Details
NCT Number NCT07360119
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions Periampullary Neoplasms, Pancreatic Cancer, Pancreatic Neoplasms
Enrollment 20 participants
Start Date 2026-09-01
Primary Completion 2031-01-01 (estimated)
Study Completion 2031-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-04