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

Not Applicable

Recruiting

• Conditions: Human Genetics and Inherited Disorders - Other human genetics and inherited disorders; Hereditary Pancreatitis; Cancer - Pancreatic; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12623001112651
• Lead Sponsor: Central Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-25
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control<br>Instruments; Composite measure of Serum HbA1c, fasting c-peptide and average daily insulin dose.<br>Data will be collected during routine clinical follow-up appointments,[ < 1 month pre-TPIAT and 3, 6, 12, 24 and 36 months post TP-IAT];Analgesic requirement<br>Instrument: Composite measure of daily pain medication and dosage.<br>Data will be collected during routine clinical follow-up appointments.[ < 1 month pre-TPIAT and 3, 6, 12, 24 and 36 months post TP-IAT]

Secondary Outcome Measures

Name	Time	Method
Quality of Life[ < 1 month pre TP-IAT and 12, 24 and 36 months post TP-IAT<br>Instrument: SF-12 assessment tool]