RecruitingACTRN12623001112651

HEPATA- HEreditary Pancreatitis and Auto-islet transplant Trials Australia.

HEPATA- HEreditary Pancreatitis and Auto-islet transplant Trials Australia: Effect on analgesic requirement and glycemic control.

Sponsor

Central Adelaide Local Health Network

Enrollment

24 participants

Start Date

Jun 28, 2022

Study Type

Interventional

Conditions

Hereditary Pancreatitis

Summary

The HEPATA Trial is designed to deliver comprehensive evidence for TP-IAT inclusion on the Australian Medicare Benefits Schedule. This will provide activity based funding enabling equitable access to this therapeutic intervention to all Australians and dramatically improve outcomes and prognosis for all HP patients. It will also inform the generation of clinical guidelines for treatment of hereditary pancreatitis with TP-IAT. This study is designed to deliver comprehensive evidence for Total Pancreatectomy and Islet-Auto Transplantation (TP-IAT) inclusion on the Australian Medicare Benefits Schedule for patients with hereditary pancreatitis Who is it for? You may be eligible to join this study if you are less than 75 years old and have molecular genotype-confirmed hereditary pancreatitis (PRSS-1, SPINK-1, CFTR, CTRC) and symptoms of pancreatitis Study details All participants in this study will undergo a total pancreatectomy procedure performed by a hepatobiliary surgeon. The pancreas will then be prepared for transport to the islet cell isolation facility by a renal surgeon. Islet cells are isolated for transplantation the same day. A radiologist transplants the isolated islet cells back (via infusion) into the patient. Participants will then be followed-up and assessed regularly at 3, 6, 12, 24 and 36 months post-procedure to determine impact of TP-IAT on glycemic control, pain and quality of life. It is hoped that this research project will provide evidence to support an application for activity based funding for the TP-IAT procedure through the Australian Medicare Benefits Schedule. This would ensure all Australians have access to this treatment in the future

Eligibility

Sex: Both males and femalesMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

The HEPATA Trial is investigating a surgical procedure called Total Pancreatectomy with Islet Auto-Transplantation (TP-IAT) for people with hereditary pancreatitis — a painful genetic condition that causes repeated inflammation of the pancreas. In severe cases, the constant pain and repeated hospitalisations can destroy a person's quality of life. TP-IAT involves removing the entire pancreas (to eliminate the source of pain), then harvesting the insulin-producing islet cells and transplanting them back into the patient via the liver — helping to prevent or reduce post-surgical diabetes. This procedure is available in other countries but is not yet funded on Australia's Medicare Benefits Schedule. This trial aims to build the evidence needed to get it covered, so all Australians with hereditary pancreatitis can access it. You may be eligible if you have a genetically confirmed hereditary pancreatitis diagnosis (involving genes such as PRSS1, SPINK1, CFTR, or CTRC), have chronic abdominal pain lasting more than six months, and have not responded to other medical or endoscopic treatments. Participants must be under 75 years old. Those with suspected pancreatic cancer, heavy alcohol use, or other identifiable non-genetic causes of pancreatitis are not eligible. All participants will be followed for three years after the procedure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Total Pancreatectomy and Islet-Auto Transplantation (TP-IAT or TPIAT) Admission: Patient admitted the day before the Pancreatectomy and Islet transplant, pre-operative bloods taken and reviewed by he

Total Pancreatectomy and Islet-Auto Transplantation (TP-IAT or TPIAT) Admission: Patient admitted the day before the Pancreatectomy and Islet transplant, pre-operative bloods taken and reviewed by hepatobiliary surgical team. Pancreatectomy: Surgery (3-5 hours duration)scheduled early morning allowing time to transport the organ to islet cell isolation facility in Melbourne. Hepatobiliary Surgeon to remove the pancreas and hand to renal surgeon who will perfuse and prepare the organ to be packed for transport. The patient then goes to recovery and then ICU until later returning to operating theatres/angiography suite for Islet transplant late evening on the same day. Islet Transplant: Radiologist performs percutaneous puncture of the portal vein and positions the infusion catheter at the bifurcation of the vein to deliver cells to both lobes of the liver. Islet cells are infused into the liver via the catheter by gravity over a 15-30 min period. The patient then goes to recovery/ ICU. Once stable the patient is admitted to the renal transplant ward until hospital discharge 5-7 days after the TPIAT procedure. Total duration of procedure 1-2 hours. Currently, access to this treatment is only available through this study and is one of the primary reasons for this trial. The aim being to capture enough outcome data to support an application for activity based funding for the procedure through the Australian Medicare Benefits Schedule. This would ensure all Australians have access to this treatment in the future.