Pancreatectomy for Pancreatitis, Chronic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
OHSU Knight Cancer Institute, Portland, OR
Pancreatitis, Chronic+5 More
Pancreatectomy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Pancreatitis, Chronic
  • Benign Pancreatic Neoplasm
  • Pancreatitis

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 2 years

Year 2
Insulin free rate
Opiates free rate
Time to overall survival (OS)
Year 2
Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary
Up to 2 years
Incidence of adverse events (AEs)
Pain-related outcomes
Quality of life (QOL)

Trial Safety

Trial Design

1 Treatment Group

Treatment (pancreatectomy, autologous islet cell transplant)
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Pancreatectomy · No Placebo Group · Phase 1 & 2

Treatment (pancreatectomy, autologous islet cell transplant)Experimental Group · 3 Interventions: Treatment Planning, Pancreatectomy, Quality-of-Life Assessment · Intervention Types: Other, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pancreatectomy
2012
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: OHSU Knight Cancer Institute · Portland, OR
Photo of Portland 1Photo of Portland 2Photo of Portland 3
2003First Recorded Clinical Trial
1 TrialsResearching Pancreatitis, Chronic
104 CompletedClinical Trials

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
206 Previous Clinical Trials
2,090,830 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
880 Previous Clinical Trials
6,828,317 Total Patients Enrolled
2 Trials studying Pancreatitis, Chronic
264 Patients Enrolled for Pancreatitis, Chronic
Brett C SheppardPrincipal InvestigatorOHSU Knight Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must provide written informed consent before any study-specific procedures or interventions are performed.
Gender-nonconforming and gender-fluid individuals will be included
You have adequate islet cell function (non-diabetic or C-peptide positive).
Pancreatic calcification on CT scan.
You have abnormal endoscopic pancreatic function tests.
You have a documented hereditary pancreatitis gene mutation or a history of recurrent acute pancreatitis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.