Total pancreatectomy with islet transplantation for high-risk periampullary pancreatic tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, single-arm feasibility study conducted at Johns Hopkins. It aims to determine if eligible adults can be recruited and consented to undergo total pancreatectomy with islet autotransplantation as an alternative to pancreaticoduodenectomy. The study will collect perioperative safety data, metabolic outcomes, and early oncologic outcomes up to 12 months after surgery. Feasibility will be judged by annual accrual rate and consent yield among approached patients. Procedures may be done open or robotically.

Why it matters

Who can join: the full rules

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.

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Jin He, MD — SKCCC Johns Hopkins Medical Institution
• Study coordinator: Jin He, MD, PhD
• Email: jhe11@jhmi.edu
• Phone: +1(410)614-7551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.