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

Sponsor

Manchester University NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT04312984

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

39.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 30, 2015

Actual Primary Completion Date :

Dec 23, 2015

Actual Study Completion Date :

Dec 23, 2015

Outcome Measures

Primary Outcome Measures

Pain Relief [10 years]
Insulin Dependence [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Chronic Pancreatitis treated with Long term anti-oxidants

Exclusion Criteria:

Cancer, On trials

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manchester Royal Infirmary	Manchester		United Kingdom

Sponsors and Collaborators

Manchester University NHS Foundation Trust

Investigators

Principal Investigator: Ajith K Siriwardena, MD FRCS, CMFT

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manchester University NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04312984

Other Study ID Numbers:

CMFT-IRAS-145239-1.8

First Posted:

Mar 18, 2020

Last Update Posted:

Mar 18, 2020

Last Verified:

Mar 1, 2020

Additional relevant MeSH terms:

Pancreatitis

Pancreatitis, Chronic

Study Results

No Results Posted as of Mar 18, 2020