Periampullary NeoplasmsNCT07360119
Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors
A study testing Total Pancreatectomy with Islet Autotransplantation (TPIAT) in people with Periampullary Neoplasms and Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periampullary Neoplasms, Pancreatic Cancer, Pancreatic Neoplasms
- What is being tested?
- Total Pancreatectomy with Islet Autotransplantation (TPIAT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas McPhaul, MS contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Jin He, MD, PhD, 410-614-7551, jhe11@jhmi.edu
About this study
Official 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
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.
- Being tested
- Total Pancreatectomy with Islet Autotransplantation (TPIAT)
- Keywords
- Total pancreatectomy, Islet autotransplantation, TPIAT, Postoperative pancreatic fistula, Pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Pancreatectomy with Islet Autotransplantation (TPIAT)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Total Pancreatectomy With Islet Autotransplantation | Experimental | 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. Receives: Procedure: Total Pancreatectomy with Islet Autotransplantation (TPIAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual accrual rate of participants who consent to and undergo planned TPIAT
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.
Measured: From study opening through completion of enrollment, up to 36 months
Consent yield among eligible patients approached for participation
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.
Measured: From study opening through completion of enrollment, up to 36 months
Secondary outcomes (10)
Incidence of major postoperative complications within 90 days after 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.
Measured: Up to 90 days post surgery
Unplanned readmission within 90 days after surgery
Number and percentage of participants with at least one unplanned hospital readmission within 90 days after TPIAT.
Measured: Up to 90 days post surgery
Length of hospital stay
Number of days from the date of TPIAT to hospital discharge.
Measured: From date of surgery to date of discharge, assessed up to 90 days
Incidence of hypoglycemic events requiring hospitalization
Number and percentage of participants experiencing hypoglycemic events requiring hospitalization after TPIAT.
Measured: Up to 12 months post surgery
Incidence of endocrine pancreatic insufficiency
Number and percentage of participants with endocrine pancreatic insufficiency after TPIAT, assessed using insulin requirement, fasting glucose, fasting C-peptide, and hemoglobin A1c.
Measured: At 3, 6, and 12 months post surgery
Average Daily Insulin requirement (IU/kg/day) after TPIAT
Average daily insulin requirement after TPIAT, assessed at postoperative months 3, 6, and 12.
Measured: At 3, 6, and 12 months post surgery
Fasting glucose (percentage) after TPIAT
Fasting glucose level measured after TPIAT
Measured: At 3, 6, and 12 months post surgery
Fasting C-peptide (ng/mL) after TPIAT
Fasting C-peptide level measured after TPIAT.
Measured: At 3, 6, and 12 months after surgery
Hemoglobin A1c (percentage) after TPIAT
Hemoglobin A1c measured after TPIAT.
Measured: At 3, 6, and 12 months after surgery
Tumor recurrence within 1 year after surgery
Number and proportion of participants with clinical, radiographic, or pathologic evidence of tumor recurrence within 1 year after TPIAT.
Measured: Within 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Sep 2026
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullary NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm feasibility study in which all enrolled participants undergo open or robotic total pancreatectomy with islet auto-transplantation.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin He, MD, Principal investigator, SKCCC Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360119
- Sponsor's protocol ID
- J2605
- Other IDs
- IRB00543437
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07360119
- Acronym / sponsor ID
- J2605
- Keywords
- Total pancreatectomy, Islet autotransplantation, TPIAT, Postoperative pancreatic fistula, Pancreaticoduodenectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm feasibility study in which all enrolled participants undergo open or robotic total pancreatectomy with islet auto-transplantation.
| Arm | Type | Receives |
|---|---|---|
| Total Pancreatectomy With Islet Autotransplantation | Experimental | Procedure: Total Pancreatectomy with Islet Autotransplantation (TPIAT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Total Pancreatectomy With Islet Autotransplantation |
Primary outcome
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.
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.
10 secondary outcomes
Incidence of major postoperative complications within 90 days after surgery
Time frame: Up to 90 days post surgery
Unplanned readmission within 90 days after surgery
Time frame: Up to 90 days post surgery
Length of hospital stay
Time frame: From date of surgery to date of discharge, assessed up to 90 days
Incidence of hypoglycemic events requiring hospitalization
Time frame: Up to 12 months post surgery
Incidence of endocrine pancreatic insufficiency
Time frame: At 3, 6, and 12 months post surgery
Average Daily Insulin requirement (IU/kg/day) after TPIAT
Time frame: At 3, 6, and 12 months post surgery
Fasting glucose (percentage) after TPIAT
Time frame: At 3, 6, and 12 months post surgery
Fasting C-peptide (ng/mL) after TPIAT
Time frame: At 3, 6, and 12 months after surgery
Hemoglobin A1c (percentage) after TPIAT
Time frame: At 3, 6, and 12 months after surgery
Tumor recurrence within 1 year after surgery
Time frame: Within 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas McPhaul, MS contact
Jin He, MD principal investigator
SKCCC Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Pancreatectomy with Islet Autotransplantation (TPIAT) in people with Periampullary Neoplasms and Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin He, MD, PhD (+1(410)614-7551, jhe11@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.