Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis

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Brief Title

Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis

Official Title

A Prospective Study of Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis

Brief Summary

      Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic
      chronic pancreatitis such as analgesic medication, inhibition of gastric acid production,
      enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and
      endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting
      benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic
      chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on
      the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not
      available in literature.

      Although it is well known that pain is the main symptom of chronic pancreatitis, it has until
      now been assessed in very common and varying categories. Pain, however, is only one aspect of
      the large variety of sensitive facets of daily life. In addition to an improvement in pain
      symptoms and the preservation of pancreatic exocrine and endocrine function and other
      parameters, occupational rehabilitation of these mostly young patients and quality of life
      also should be considered in the evaluation of surgical outcome in alcoholic and
      non-alcoholic chronic pancreatitis.

      In this prospective study, we intend to find out if there are any differences in the surgical
      outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic
      pancreatitis.We also plan to see if there are differences in the histopathology in these two
      disease settings.
    



Study Type

Observational


Primary Outcome

Quality of life

Secondary Outcome

 Pain relief

Condition

Pancreatitis, Chronic

Intervention

Frey's procedure/Pylorus preserving pancreatoduodenectomy

Study Arms / Comparison Groups

 Alcoholic
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

24

Start Date

January 2012

Completion Date

June 2014

Primary Completion Date

June 2014

Eligibility Criteria

        Inclusion Criteria:

        Diagnosis of chronic pancreatitis confirmed by at least 2 of the following:

          1. Typical Chronic epigastric abdominal pain

          2. Elevation of serum Amylase>3 times upper limit normal or

          3. Fecal elastase less than 200ug/g stool.

          4. Confirmatory findings on cross-sectional imaging:

               1. Changes in size, shape and contour of pancreas

               2. Dilatation of main pancreatic duct

               3. Calcification

               4. Pseudocyst

               5. Pancreatic duct stricture

          5. Patients who fulfill the criteria for surgical intervention

        Exclusion Criteria:

          -  Not agreeing for surgical management

          -  On going acute pancreatitis

          -  Postop alcohol intake

          -  Pregnancy.

          -  Chronic pancreatitis with Malignancy
      

Gender

All

Ages

15 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Rajesh Gupta, M.Ch., , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT02048267

Organization ID

NK/338/MS/9609-1


Responsible Party

Principal Investigator

Study Sponsor

Postgraduate Institute of Medical Education and Research


Study Sponsor

Rajesh Gupta, M.Ch., Principal Investigator, Professor


Verification Date

November 2014