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

Inclusion Criteria7

Individuals must have molecular genotype-confirmed Hereditary Pancreatitis (PRSS-1,SPINK-1,CFTR,CTRC ) AND symptoms of Pancreatitis fulfilling the Minnesota Criteria for TP-IAT
The Minnesota criteria:
(1) Diagnosis of pancreatitis with the features of chronic abdominal pain of > 6 months duration with evidence of; i), identified gene mutation (PRSS1, SPINK1, CRTR, CTRC); ii), pancreatic calcification on CT scan; iii), > 4/9 Endoscopic Ultrasound Criteria (EUS); iv), histological confirmed diagnosis of CP.
(2) At least one of the following: daily narcotic dependence, pain resulting in impaired quality of life which may include: inability to attend school, recurrent hospitalisations and inability to participate in usual, age appropriate activities.
(3) Complete evaluation with no reversible cause of pancreatitis present or untreated.
(4) Failure to respond to maximal medical therapy and endoscopic therapy.
(5) Adequate islet cell function (non-diabetic or C-peptide positive).

Exclusion Criteria1

Absolute contraindications: suspicion of pancreatic carcinoma complicating chronic pancreatitis, presence of intrapapillary mucinous neoplasia (IPMNs), ongoing significant alcohol consumption. Relative Contraindications: anticipated poor islet yields due to: age (>75 yrs), previous pancreatic surgery and insulin dependency, increased surgical risks due to hostile abdomen (previous abdominal catastrophies) and surgical comorbidities (morbid obesity, ongoing smoking) and pregnancy. Patients with acute pancreatitis with other readily identifiable non-genetic causes such as alcohol, gall stone, auto-immune pancreatitis, hyper-triglyceridaemia and anatomic variants e.g. pancreas divisum and without a family history that is suggestive of an inherited disorder.

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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.