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OpenTrials
Completed

NCT Number: NCT02048267

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

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.

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Typical Chronic epigastric abdominal pain
  • Elevation of serum Amylase>3 times upper limit normal or
  • Fecal elastase less than 200ug/g stool.
  • Confirmatory findings on cross-sectional imaging:
  • Changes in size, shape and contour of pancreas
  • Dilatation of main pancreatic duct
  • Calcification
  • Pseudocyst
  • Pancreatic duct stricture
  • 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

Treatment and study plan

Frey's procedure/Pylorus preserving pancreatoduodenectomy

Procedure

Duodenum preserving head resection

Primary outcomes

  1. Quality of life

    Time frame: Within first 6 months from the time of surgery

  2. Differences in extent of parenchymal fibrosis, inflammation and ductal obstruction of alcoholic and non alcoholic chronic pancreatitis

    Time frame: Two weeks after surgery

Secondary outcomes

  1. Pain relief

    Time frame: Within first 6 months after surgery

  2. HbA1C,Fasting insulin and C-peptide levels

    Time frame: Within first 6 months after surgery

  3. Fecal elastase levels

    Time frame: Within first 6 months after surgery

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2014
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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