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

Completed

• Conditions: Pancreatitis, Chronic
• Interventions: Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy

• Registration Number: NCT02048267
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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 available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-01-18
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-08
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alcoholic	Frey's procedure/Pylorus preserving pancreatoduodenectomy	-
Non alcoholic	Frey's procedure/Pylorus preserving pancreatoduodenectomy	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India