Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-03-06 @ 12:08 PM
Study NCT ID:
NCT02048267
Status:
COMPLETED
Last Update Posted:
2014-11-11
First Post:
2014-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-08', 'studyFirstSubmitDate': '2014-01-18', 'studyFirstSubmitQcDate': '2014-01-27', 'lastUpdatePostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'keywords': ['Alcoholic', 'Non alcoholic', 'Idiopathic', 'Tropical', 'Exocrine dysfunction', 'Endocrine dysfunction', 'Pain control', "Frey's procedure", 'Duodenum preserving pancreatic head resection'], 'conditions': ['Pancreatitis, Chronic']}, 'descriptionModule': {'briefSummary': '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.\n\nAlthough 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of chronic pancreatitis with unremitting pain requiring surgery at primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of chronic pancreatitis confirmed by at least 2 of the following:\n\n1. Typical Chronic epigastric abdominal pain\n2. Elevation of serum Amylase\\>3 times upper limit normal or\n3. Fecal elastase less than 200ug/g stool.\n4. Confirmatory findings on cross-sectional imaging:\n\n 1. Changes in size, shape and contour of pancreas\n 2. Dilatation of main pancreatic duct\n 3. Calcification\n 4. Pseudocyst\n 5. Pancreatic duct stricture\n5. Patients who fulfill the criteria for surgical intervention\n\nExclusion Criteria:\n\n* Not agreeing for surgical management\n* On going acute pancreatitis\n* Postop alcohol intake\n* Pregnancy.\n* Chronic pancreatitis with Malignancy'}, 'identificationModule': {'nctId': 'NCT02048267', 'briefTitle': 'Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'officialTitle': 'A Prospective Study of Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis', 'orgStudyIdInfo': {'id': 'NK/338/MS/9609-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alcoholic', 'interventionNames': ["Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy"]}, {'label': 'Non alcoholic', 'interventionNames': ["Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy"]}], 'interventions': [{'name': "Frey's procedure/Pylorus preserving pancreatoduodenectomy", 'type': 'PROCEDURE', 'description': 'Duodenum preserving head resection', 'armGroupLabels': ['Alcoholic', 'Non alcoholic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'country': 'India', 'facility': 'Postgraduate Institute of Medical Education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'overallOfficials': [{'name': 'Rajesh Gupta, M.Ch.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Additional Professor', 'investigatorFullName': 'Rajesh Gupta', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}