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

April 10, 2015 updated by: Md Tanveer Adil, Medical College and Hospital Kolkata

A Single Centre Analysis of Clinical Characteristics and Treatment of Endocrine Pancreatic Tumours.

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Pathological reports and Prooperative CAT Scan showing Endocrine Pancreatic Tumours

Exclusion Criteria:

  • Nonendocrine Pancreatic Tumours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Each participant was followed up for a period of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College and Hospital Kolkata

Collaborators

Sir Ganga Ram Hospital

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGRH-SGLT-MTA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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