Clinical trial NCT04312984: The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis
Official title: The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Chronic Pancreatitis using the Zurich workshop criteria

Brief summary: This is a anonymised case note study looking at the long term outcomes of patients with Chronic Pancreatitis on micro nutrient antioxidant treatment.

Detailed description: Chronic pancreatitis is the medical term for chronic inflammation of the pancreas. This illness is associated with long-term abdominal pain. In the 1980s it was proposed that chronic pancreatitis was due to a deficiency of protective "antioxidants" in the pancreas and on this basis antioxidant therapy was introduced. This therapy was highly controversial until a large randomised trial of antioxidant therapy in chronic pancreatitis, undertaken in Manchester showed that 6 months intervention with antioxidant therapy was not associated with any change in pain score or improvement in quality of life. Antioxidant therapy is no longer used in modern day pancreatic practice.

However, as with any study, the randomised trial raised some specific questions.

First, does treatment for more than 6 months provide benefit? Second, are there disease sub-types of chronic pancreatitis where antioxidant therapy may benefit?

Given the lack of contemporary use of antioxidant therapy, this question cannot be answered in a prospective study. However, the case records of the Manchester Royal Infirmary contain information on antioxidant treatment in patients who received this therapy over a prolonged period.

Thus the aim of the present study is to review the case notes of patients given a discharge code from the Manchester Royal Infirmary of chronic pancreatitis during the period 1st January 1990 to 1st January 1998 in order to assess whether there is a record of improvement in outcome. Only the case notes will be reviewed and patients will be given an opportunity to opt out.

The study accepts the limitations of assessing pain from clinical notes but also notes that more objective findings such as development of diabetes mellitus (a long term complication of chronic pancreatitis) can be assessed from the notes.

Eligibility criteria: Inclusion Criteria:

* Patients with Chronic Pancreatitis treated with Long term anti-oxidants

Exclusion Criteria:

* Cancer, On trials

Primary outcomes:
measure: Pain Relief
timeFrame: 10 years
measure: Insulin Dependence
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: CMFT
name: Ajith K Siriwardena, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References: