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NCT05453851 · ClinicalTrials.gov registry record · Phase 1
A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors
A Phase 1 study, sponsored by OHSU Knight Cancer Institute.
- Not yet
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT05453851: Clinical Trial Phase 1 study, sponsored by OHSU Knight Cancer Institute.
NCT05453851 is a Phase 1 study that has not yet begun recruiting, run by OHSU Knight Cancer Institute. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05453851, a Phase 1 study, has not yet begun recruiting, sponsored by OHSU Knight Cancer Institute.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This phase I/II trial assesses the safety and effectiveness of total pancreatectomy with islet cell autotransplantation for the treatment of patients with long-term pancreatic inflammation (chronic pancreatitis) and non-cancerous (benign) pancreatic tumors. Total removal of the pancreas (pancreatectomy) can be used to treat chronic pancreatitis, but it may result in diabetes. An islet cell autotransplantation involves removing cells from a patient's pancreas (the islet cells) and infusing them into the liver. Islet cells are responsible for producing hormones like insulin, reducing the occurrence of diabetes in patients undergoing total pancreatectomy. Total pancreatectomy with autologous islet cell transplant is an accepted and Food and Drug Administration-approved treatment for patients with chronic pancreatitis. However, patients with chronic pancreatitis and pancreatic tumors have historically not been candidates for this procedure due to concerns of spreading potentially cancerous cells to other parts of the body. This clinical trial evaluates the safety and effectiveness of this treatment in patients with chronic pancreatitis and benign pancreatic tumors.
Primary Outcome
The 95% confidence interval (CI) will be analyzed using the Clopper-Pearson exact interval method.
Interventions
- OTHER Quality-of-Life Assessment
- PROCEDURE Pancreatectomy
- OTHER Treatment Planning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 1 |
What is known before NCT05453851 opens enrollment
NCT05453851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05453851 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05453851 about?
NCT05453851 is a clinical study titled "A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors". This phase I/II trial assesses the safety and effectiveness of total pancreatectomy with islet cell autotransplantation for the treatment of patients with long-term pancreatic inflammation (chronic pancreatitis) and non-cancerous (benign) pancreatic tumors. Total removal of the pancreas (pancreatect...
What is the current status of trial NCT05453851?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-07-01. Estimated completion is 2030-07-01.
What interventions are being tested in trial NCT05453851?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Pancreatectomy (PROCEDURE), Treatment Planning (OTHER).
Who is sponsoring clinical trial NCT05453851?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05453851's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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