NCT07360119

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
52mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Jan 2031

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

4.3 years

First QC Date

January 14, 2026

Last Update Submit

September 1, 2026

Conditions

Periampullary NeoplasmsPancreatic CancerPancreatic Neoplasms

Keywords

Total pancreatectomyIslet autotransplantationTPIATPostoperative pancreatic fistulaPancreaticoduodenectomy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From study opening through completion of enrollment, up to 36 months

Secondary Outcomes (10)

  • Incidence of major postoperative complications within 90 days after surgery

    Up to 90 days post surgery

  • Unplanned readmission within 90 days after surgery

    Up to 90 days post surgery

  • Length of hospital stay

    From date of surgery to date of discharge, assessed up to 90 days

  • Incidence of hypoglycemic events requiring hospitalization

    Up to 12 months post surgery

  • Incidence of endocrine pancreatic insufficiency

    At 3, 6, and 12 months post surgery

  • +5 more secondary outcomes

Study Arms (1)

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.

Procedure: Total Pancreatectomy with Islet Autotransplantation (TPIAT)

Interventions

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.

Total Pancreatectomy With Islet Autotransplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jin He, MD

    SKCCC Johns Hopkins Medical Institution

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin He, MD, PhD

CONTACT

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

Thomas McPhaul, MS

CONTACT

tmcphau2@jhu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-arm feasibility study in which all enrolled participants undergo open or robotic total pancreatectomy with islet auto-transplantation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Last Updated

September 4, 2026

Record last verified: 2026-09

Locations

US(1)