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

Pancreatitis, Chronic Clinical Trial

Official title:

A Prospective Study of Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048267
• Other study ID #: NK/338/MS/9609-1
• Status: Completed
• Phase: N/A
• First received: January 18, 2014
• Last updated: November 8, 2014
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Post graduate Institute of Medical Education and Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Chronic

Intervention

Procedure:
• Frey's procedure/Pylorus preserving pancreatoduodenectomy
Duodenum preserving head resection

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		Within first 6 months from the time of surgery	No
Primary	Differences in extent of parenchymal fibrosis, inflammation and ductal obstruction of alcoholic and non alcoholic chronic pancreatitis		Two weeks after surgery	No
Secondary	Pain relief		Within first 6 months after surgery	No
Secondary	HbA1C,Fasting insulin and C-peptide levels		Within first 6 months after surgery	No
Secondary	Fecal elastase levels		Within first 6 months after surgery	No