Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Pancreatic Neoplasms

Pancreatitis

Pancreatitis, Chronic

Pancreatic Diseases

Gastrointestinal Diseases

Chronic Disease

Disease Attributes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1.

Pancreatectomy

Quality-of-Life Assessment

Undergo IV autologous islet cell transplant

Treatment Planning

Brett C. Sheppard

Brett C Sheppard

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 OBJECTIVE:

I. To evaluate the oncologic safety of total pancreatectomy with islet cell autotransplantation (TPIAT) in chronic pancreatitis patients with benign pancreatic neoplasms.

SECONDARY OBJECTIVES:

I. To evaluate postoperative insulin requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT.

II. To evaluate postoperative opiate requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT.

III. To evaluate the postoperative survival of patients with presumed benign pancreatic neoplasms undergoing TPIAT.

EXPLORATORY OBJECTIVES:

I. To evaluate quality of life outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms.

II. To evaluate subjective pain-related outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms.

OUTLINE:

Patients undergo total pancreatectomy and autologous islet cell transplant intravenously (IV) over 15-60 minutes on day 1.

After completion of study treatment, patients are followed up for 2 years.

A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors

Total Pancreatectomy With Islet Cell Autotransplantation in Patients With Benign Pancreatic Neoplasms: A Pilot Study

QOL scores will be collected over time using the Short Form 12. Summary of QOL and its change over time will be presented graphically using box plot and spaghetti plots, in addition to a summary table of QOL over time.

Subjective pain-related outcomes will be collected using Patient Reported Outcomes Measurement Information System Bank Pain Interference Survey, version 1.1 and will be analyzed similar to the QOL survey.

AEs of grade 3 or greater will be collected and tabulated by the Medical Dictionary for Regulatory Activities version 21.1. By-patient listings will also be provided for the following: patient deaths, serious adverse events, and AEs leading to withdrawal.

The 95% confidence interval (CI) will be analyzed using the Clopper-Pearson exact interval method.

Defined as proportion not requiring insulin for blood glucose control for at least 14 days prior to the assessment date at 2 years. The 95% CI will be analyzed using Clopper-Pearson exact interval method.

Defined as proportion not receiving opiates for at least 14 days prior to the assessment date at 2 years.The 95% CI will be analyzed using Clopper-Pearson exact interval method.

The time to OS distribution will be characterized using the Kaplan-Meier method. Kaplan-Meier curves of OS rate at 2 years will be estimated from the survival curve along with the 95% CI.

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Infections

Communicable Diseases

Surgical Wound Infection

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

Biospecimen Collection

Laboratory Procedure

Nanopore Sequencing

Nicholas D Chia

This early phase I trial evaluates nanopore sequencing for its ability to detect bacteria in bile and prevent surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Using nanopore sequencing to detect bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.

PRIMARY OBJECTIVE:

I. To improve antibiotic stewardship (reducing duration of peri-operative prophylactic antibiotic regimen, reducing administration of broad-spectrum antibiotic) by providing surgical team with rapid Oxford Nanopore (ONT) sequencing data in the early post-operative setting.

SECONDARY OBJECTIVE:

I. To reduce the cost of care through reduction in surgical site infection (SSI) and improved antibiotic stewardship.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

ARM II: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

After completion of study, patients' medical records are reviewed for 30 days.

"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures

Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors

For continuous variables, t-test will be performed and for binary variables chi-square or fisher's exact testing will be performed as appropriate. Additional analysis will be performed as necessary to determine differences in study arms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors	NCT05453851	Benign Pancreat... Chronic Pancrea... Recurrent Acute...	Pancreatectomy Quality-of-Life... Treatment Plann...	18 Years -	OHSU Knight Cancer Institute
"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures	NCT05523154	Benign Pancreat... Malignant Pancr...	Biospecimen Col... Laboratory Proc... Nanopore Sequen...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for benign pancreatic neoplasm