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

A Prospective Study of 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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis, Chronic
• Intervention / Treatment: Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of life	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	Two weeks after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain relief	Within first 6 months after surgery
HbA1C,Fasting insulin and C-peptide levels	Within first 6 months after surgery
Fecal elastase levels	Within first 6 months after surgery

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Rajesh Gupta, M.Ch., Professor

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: January 18, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (ESTIMATE): January 29, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 11, 2014
• Last Update Submitted That Met QC Criteria: November 8, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Alcoholic; Pain control; Idiopathic; Non alcoholic; Tropical; Exocrine dysfunction; Endocrine dysfunction; Frey's procedure; Duodenum preserving pancreatic head resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: NK/338/MS/9609-1