Recruiting

Islet Autotransplantation

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT07360119

Conditions

Periampullary Neoplasms

Pancreatic Cancer

Pancreatic Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total Pancreatectomy with Islet Autotransplantation (TPIAT)

Study Details

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.

Conditions

Periampullary Neoplasms

Pancreatic Cancer

Pancreatic Neoplasms

Study ID

NCT07360119

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jan 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Total Pancreatectomy With Islet Autotransplantation

Participants with periampullary neoplasms who are considered at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy will undergo total pancreatectomy with islet autotransplantation using either an open or robotic surgical approach. Outcomes will be assessed prospectively through 12 months after surgery.

Interventions

Total 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.

Primary outcome measure

  • 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 ]
  • Consent yield among eligible patients approached for participation [ Time Frame: From study opening through completion of enrollment, up to 36 months ]

Central Contacts and Locations

Central contacts

Jin He, MD, PhD

+1(410)614-7551jhe11@jhmi.edu

Thomas McPhaul, MS

tmcphau2@jhu.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jin He, MD, PhD

410-614-7551jhe11@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Total pancreatectomy
  • Islet autotransplantation
  • TPIAT
  • Postoperative pancreatic fistula
  • Pancreaticoduodenectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-09-04.