Clinical trial NCT02048267: Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis
Official title: A Prospective Study of Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis, Chronic
Keywords: Alcoholic
Non alcoholic
Idiopathic
Tropical
Exocrine dysfunction
Endocrine dysfunction
Pain control
Frey's procedure
Duodenum preserving pancreatic head resection
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2014-01-29
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients of chronic pancreatitis with unremitting pain requiring surgery at primary care clinic

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.


Eligibility 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

Primary outcomes:
measure: Quality of life
timeFrame: Within first 6 months from the time of surgery
measure: Differences in extent of parenchymal fibrosis, inflammation and ductal obstruction of alcoholic and non alcoholic chronic pancreatitis
timeFrame: Two weeks after surgery
Secondary outcomes:
measure: Pain relief
timeFrame: Within first 6 months after surgery
measure: HbA1C,Fasting insulin and C-peptide levels
timeFrame: Within first 6 months after surgery
measure: Fecal elastase levels
timeFrame: Within first 6 months after surgery
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: Professor
name: Rajesh Gupta, M.Ch.
role: PRINCIPAL_INVESTIGATOR
References: