The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis

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

Study Overview

• Status: Completed
• Conditions: Chronic Pancreatitis

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • Manchester Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Chronic Pancreatitis using the Zurich workshop criteria

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Cancer, On trials

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Relief	10 years
Insulin Dependence	10 years

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Ajith K Siriwardena, MD FRCS, CMFT

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2015
• Primary Completion (ACTUAL): December 23, 2015
• Study Completion (ACTUAL): December 23, 2015

Study Registration Dates

• First Submitted: April 3, 2015
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (ACTUAL): March 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: CMFT-IRAS-145239-1.8