MedDataX Logo

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

NCT ID: NCT02048267

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatitis, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alcoholic

Frey's procedure/Pylorus preserving pancreatoduodenectomy

Intervention Type PROCEDURE

Duodenum preserving head resection

Non alcoholic

Frey's procedure/Pylorus preserving pancreatoduodenectomy

Intervention Type PROCEDURE

Duodenum preserving head resection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Frey's procedure/Pylorus preserving pancreatoduodenectomy

Duodenum preserving head resection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rajesh Gupta

Additional Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rajesh Gupta, M.Ch.

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NK/338/MS/9609-1

Identifier Type: -

Identifier Source: org_study_id