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

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ClinicalTrials.gov Identifier: NCT02048267
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : November 11, 2014
Sponsor:
Information provided by (Responsible Party):
Rajesh Gupta, Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date January 18, 2014
First Posted Date January 29, 2014
Last Update Posted Date November 11, 2014
Study Start Date January 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2014)
  • Quality of life [ Time Frame: Within first 6 months from the time of surgery ]
  • Differences in extent of parenchymal fibrosis, inflammation and ductal obstruction of alcoholic and non alcoholic chronic pancreatitis [ Time Frame: Two weeks after surgery ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02048267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 27, 2014)
  • Pain relief [ Time Frame: Within first 6 months after surgery ]
  • HbA1C,Fasting insulin and C-peptide levels [ Time Frame: Within first 6 months after surgery ]
  • Fecal elastase levels [ Time Frame: Within first 6 months after surgery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients of chronic pancreatitis with unremitting pain requiring surgery at primary care clinic
Condition Pancreatitis, Chronic
Intervention Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy
Duodenum preserving head resection
Study Groups/Cohorts
  • Alcoholic
    Intervention: Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy
  • Non alcoholic
    Intervention: Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2014)
24
Original Estimated Enrollment
 (submitted: January 27, 2014)
20
Actual Study Completion Date June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT02048267
Other Study ID Numbers NK/338/MS/9609-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rajesh Gupta, Postgraduate Institute of Medical Education and Research
Study Sponsor Postgraduate Institute of Medical Education and Research
Collaborators Not Provided
Investigators
Principal Investigator: Rajesh Gupta, M.Ch. Professor
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date November 2014