New surgery aims to cut pancreatic leak and diabetes risk

NCT ID NCT07360119

Disease control Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests a surgery called total pancreatectomy with islet autotransplantation (TPIAT) in 30 adults with certain pancreatic tumors who are at high risk for a dangerous leak after standard surgery. The procedure removes the entire pancreas and transplants the insulin-making cells into the liver to help prevent severe diabetes. Researchers will track complications, hospital stay length, and how well the transplanted cells work to see if this approach is safe and feasible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Total pancreatectomy with islet autotransplantation (TPIAT) – a surgery to remove the pancreas and transplant its insulin-making cells into the liver
What this could lead to: If successful, this approach could offer a safer surgical option for patients with certain pancreatic tumors, reducing the chance of a dangerous pancreatic leak and lowering the risk of severe diabetes after surgery.
What could go wrong: This is a very early, small study (30 people) with no comparison group, so results may not apply broadly. The surgery is major and carries risks like infection, bleeding, and the transplanted cells may not work well enough to prevent diabetes.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

distal biliary tract carcinoma duodenal adenocarcinoma extrahepatic bile duct adenocarcinoma gastrointestinal stromal tumor malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic intraductal papillary-mucinous neoplasm pancreatic mucinous-cystic neoplasm pancreatic neoplasm pancreatic neuroendocrine neoplasm periampullary adenocarcinoma serous cystadenoma small intestine leiomyosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer Pancreatic neoplasms Periampullary neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New surgery aims to cut pancreatic leak and diabetes risk

What the study statuses mean