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

NCT02048267 | Completed

• 1 other identifier: NK/338/MS/9609-1
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis, Chronic

Keywords

Alcoholic; Non alcoholic; Idiopathic; Tropical; Exocrine dysfunction; Endocrine dysfunction; Pain control; Frey's procedure; Duodenum preserving pancreatic head resection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Alcoholic

Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy

Non alcoholic

Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy

Interventions

Frey's procedure/Pylorus preserving pancreatoduodenectomy PROCEDURE

Duodenum preserving head resection

Alcoholic; Non alcoholic

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Not agreeing for surgical management
• On going acute pancreatitis
• Postop alcohol intake
• Pregnancy.
• Chronic pancreatitis with Malignancy

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Agnosia

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Rajesh Gupta, M.Ch.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: January 18, 2014
• First Posted: January 29, 2014
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

IN (1)