Graft function after autologous islet transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll 100 adults with chronic pancreatitis who are scheduled for total pancreatectomy with islet autotransplantation (TP-AIT) or total pancreatectomy (TP) alone at Baylor centers. Blood samples will be collected serially to measure inflammatory markers and blood-based indicators of islet graft function such as C-peptide and glucose control. The cohort includes up to 85 TP-AIT and 15 TP-alone participants and may include patients concurrently enrolled in a reparixin interventional protocol. Data will be analyzed to correlate perioperative inflammation with subsequent islet graft performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with chronic pancreatitis and who are scheduled for TP alone or TP-AIT
2. Patients aged 18 or older
3. Patients are able and willing to attend required follow-up visits at Baylor

Exclusion Criteria:

1. Patients who are unable/unwilling to attend follow-up visits at Baylor
2. For TP-AIT subjects: Patients who have advanced stage of chronic pancreatitis. The principal investigator or co-investigators carefully review the medical charts, laboratory results and radiology department reports and determine the suitability for this study.

Where it's running

• Baylor University Medical Center - Sammons Outpatient Cancer Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Ernest E Beecherl, MD — Sammons Cancer Center, Baylor University Medical Center
• Study coordinator: Anne M Jones, BSN, RN
• Email: anne.jones@bswhealth.org
• Phone: 214-820-7623

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.