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An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms

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ClinicalTrials.gov Identifier: NCT02400996
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
Sir Ganga Ram Hospital
Information provided by (Responsible Party):
Md Tanveer Adil, Sir Ganga Ram Hospital

Brief Summary:
A single institutional study of Pancreatic Endocrine Neoplasms over 18 years.

Condition or disease
Pancreatic Endocrine Neoplasms

Detailed Description:
The investigators did an analysis from a prospectively maintained database of patients who underwent pancreatic resections or nonresective procedures for neoplasms of the pancreas at Sir Ganga Ram Hospital from 1995 to 2013 and using pathological reports and preoperative CT scan as the gold standard, the investigators identified 40 patients with PENs.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single Centre Analysis of Clinical Characteristics and Treatment of Endocrine Pancreatic Tumours.
Study Start Date : March 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Pancreatic Endocrine Neoplasms
We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.



Primary Outcome Measures :
  1. Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms [ Time Frame: Each participant was followed up for a period of 5 years ]
    Of the 40 patients operated for Pancreatic Endocrine Neoplasms, using clinical criteria, histopathological analysis and preoperative imaging as gold standard, nonfunctioning and functioning tumours were identified. Similarly the number of benign and malignant lesions identified were recorded as per the WHO Classification of pancreatic endocrine tumours.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Medical files and electronic records were reviewed to collect information. Patients were categorized into functioning and nonfunctioning PENs based on their clinical behaviour, pathology reports and serum radioimmunoassay for offending hormones. Preoperative CT scans were used to characterize PENs and record neoplasm size and location in the pancreas. Review of operative notes was done for the type of surgery performed and peroperative findings recorded. Discharge summaries were used to study the surgical outcome in terms of duration of postoperative hospital stay and postoperative complications. Patients were followed up and any disease recurrence or disease related mortality was recorded. Evaluation of the pathology reports was done.
Criteria

Inclusion Criteria:

  • Pathological reports and Prooperative CAT Scan showing Endocrine Pancreatic Tumours

Exclusion Criteria:

  • Nonendocrine Pancreatic Tumours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400996


Sponsors and Collaborators
Medical College and Hospital Kolkata
Sir Ganga Ram Hospital
Investigators
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Principal Investigator: Md Tanveer Adil Sir Ganga Ram Hospital, New Delhi
Study Director: Raghavendra Nagaraja Sir Ganga Ram Hospital, New Delhi
Study Director: Vibha Varma Sir Ganga Ram Hospital, New Delhi
Study Director: Naimish Mehta Sir Ganga Ram Hospital, New Delhi
Study Director: Vinay Kumaran Sir Ganga Ram Hospital, New Delhi
Study Chair: Samiran Nundy Sir Ganga Ram Hospital, New Delhi

Publications of Results:
Other Publications:
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Responsible Party: Md Tanveer Adil, Fellow, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT02400996     History of Changes
Other Study ID Numbers: SGRH-SGLT-MTA
First Posted: March 27, 2015    Key Record Dates
Results First Posted: April 29, 2015
Last Update Posted: April 29, 2015
Last Verified: April 2015
Keywords provided by Md Tanveer Adil, Sir Ganga Ram Hospital:
Endocrine Pancreas
Pancreatic Endocrine Neoplasm
Additional relevant MeSH terms:
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Endocrine Gland Neoplasms
Adenoma, Islet Cell
Neoplasms
Neoplasms by Site
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases