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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Postgraduate Institute of Medical Education and Research
Sponsor:
Information provided by (Responsible Party):
Rajesh Gupta, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT02048267
First received: January 18, 2014
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Pancreatitis, Chronic
Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Within first 6 months from the time of surgery ] [ Designated as safety issue: No ]
  • Differences in extent of parenchymal fibrosis, inflammation and ductal obstruction of alcoholic and non alcoholic chronic pancreatitis [ Time Frame: Two weeks after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain relief [ Time Frame: Within first 6 months after surgery ] [ Designated as safety issue: No ]
  • HbA1C,Fasting insulin and C-peptide levels [ Time Frame: Within first 6 months after surgery ] [ Designated as safety issue: No ]
  • Fecal elastase levels [ Time Frame: Within first 6 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Alcoholic Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy
Duodenum preserving head resection
Non alcoholic Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy
Duodenum preserving head resection

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients of chronic pancreatitis with unremitting pain requiring surgery at primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048267

Locations
India
Postgraduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Rajesh Gupta       rajsarakshi@yahoo.co.in   
Sub-Investigator: Srinath S.R.         
Principal Investigator: Rajesh Gupta, M.Ch.         
Sub-Investigator: Ritambhra Nada         
Sub-Investigator: Mandeep Kang         
Sub-Investigator: Deepak K Bhasin         
Sub-Investigator: Naresh Sachdeva         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Rajesh Gupta, M.Ch. Additional Professor
  More Information

No publications provided

Responsible Party: Rajesh Gupta, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02048267     History of Changes
Other Study ID Numbers: NK/338/MS/9609-1
Study First Received: January 18, 2014
Last Updated: January 27, 2014
Health Authority: India: Post graduate Institute of Medical Education and Research

Keywords provided by Postgraduate Institute of Medical Education and Research:
Alcoholic
Non alcoholic
Idiopathic
Tropical
Exocrine dysfunction
Endocrine dysfunction
Pain control
Frey's procedure
Duodenum preserving pancreatic head resection

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014