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NCT Number: NCT07360119

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

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.

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Key information

Conditions

Periampullary Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Jin He, MD, PhD

CONTACT

[email protected]

410-614-7551

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Pancreatectomy with Islet Autotransplantation (TPIAT)

Procedure

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.

Primary outcomes

  1. Annual accrual rate of participants who consent to and undergo planned TPIAT

    Time frame: 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.

  2. Consent yield among eligible patients approached for participation

    Time frame: 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 outcomes

  1. Incidence of major postoperative complications within 90 days after surgery

    Time frame: 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.

  2. Unplanned readmission within 90 days after surgery

    Time frame: Up to 90 days post surgery

    Number and percentage of participants with at least one unplanned hospital readmission within 90 days after TPIAT.

  3. Length of hospital stay

    Time frame: From date of surgery to date of discharge, assessed up to 90 days

    Number of days from the date of TPIAT to hospital discharge.

  4. Incidence of hypoglycemic events requiring hospitalization

    Time frame: Up to 12 months post surgery

    Number and percentage of participants experiencing hypoglycemic events requiring hospitalization after TPIAT.

  5. Incidence of endocrine pancreatic insufficiency

    Time frame: 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.

  6. Average Daily Insulin requirement (IU/kg/day) after TPIAT

    Time frame: At 3, 6, and 12 months post surgery

    Average daily insulin requirement after TPIAT, assessed at postoperative months 3, 6, and 12.

  7. Fasting glucose (percentage) after TPIAT

    Time frame: At 3, 6, and 12 months post surgery

    Fasting glucose level measured after TPIAT

  8. Fasting C-peptide (ng/mL) after TPIAT

    Time frame: At 3, 6, and 12 months after surgery

    Fasting C-peptide level measured after TPIAT.

  9. Hemoglobin A1c (percentage) after TPIAT

    Time frame: At 3, 6, and 12 months after surgery

    Hemoglobin A1c measured after TPIAT.

  10. Tumor recurrence within 1 year after surgery

    Time frame: Within 12 months after surgery

    Number and proportion of participants with clinical, radiographic, or pathologic evidence of tumor recurrence within 1 year after TPIAT.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin He, MD, PhD

CONTACT

[email protected]

+1(410)614-7551

Thomas McPhaul, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study title

Total Pancreatectomy With Islet Autotransplantation (TPIAT) for Patients With Periampullary Neoplasms at High Risk for Pancreaticojejunostomy Leakage After Pancreaticoduodenectomy: a Single-center, Prospective, Single-Arm, Observational Study

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jan 22, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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