NCT02400996

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1 month until next milestone

Results Posted

Study results publicly available

April 29, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

March 23, 2015

Results QC Date

March 26, 2015

Last Update Submit

April 10, 2015

Conditions

Keywords

Endocrine PancreasPancreatic Endocrine Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms

    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

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Pathological reports and Prooperative CAT Scan showing Endocrine Pancreatic Tumours

You may not qualify if:

  • Nonendocrine Pancreatic Tumours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Vortmeyer AO, Huang S, Lubensky I, Zhuang Z. Non-islet origin of pancreatic islet cell tumors. J Clin Endocrinol Metab. 2004 Apr;89(4):1934-8. doi: 10.1210/jc.2003-031575.

    PMID: 15070966BACKGROUND
  • Halfdanarson TR, Rabe KG, Rubin J, Petersen GM. Pancreatic neuroendocrine tumors (PNETs): incidence, prognosis and recent trend toward improved survival. Ann Oncol. 2008 Oct;19(10):1727-33. doi: 10.1093/annonc/mdn351. Epub 2008 May 30.

    PMID: 18515795BACKGROUND
  • Kazanjian KK, Reber HA, Hines OJ. Resection of pancreatic neuroendocrine tumors: results of 70 cases. Arch Surg. 2006 Aug;141(8):765-9; discussion 769-70. doi: 10.1001/archsurg.141.8.765.

  • Vagefi PA, Razo O, Deshpande V, McGrath DJ, Lauwers GY, Thayer SP, Warshaw AL, Fernandez-Del Castillo C. Evolving patterns in the detection and outcomes of pancreatic neuroendocrine neoplasms: the Massachusetts General Hospital experience from 1977 to 2005. Arch Surg. 2007 Apr;142(4):347-54. doi: 10.1001/archsurg.142.4.347.

  • Heitz PU, Komminoth P, Perrin A et al. Pancreatic endocrine tumors: Introduction. In: DeLellis DA, Lloyd RV, Heitz PU, et al., eds. Pathology and Genetics of Tumours of Endocrine Organs. WHO Classification of Tumours. Lyon, France: IARC Press, 2004: 177-82.

    RESULT

MeSH Terms

Conditions

Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Limitations and Caveats

The analysis was done from a prospectively maintained database and target followup done for a period of 5 years after surgery

Results Point of Contact

Title
Md Tanveer Adil
Organization
Sir Ganga Ram Hospital, New Delhi, India

Study Officials

  • Md Tanveer Adil

    Sir Ganga Ram Hospital, New Delhi

    PRINCIPAL INVESTIGATOR
  • 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 DIRECTOR
  • Samiran Nundy

    Sir Ganga Ram Hospital, New Delhi

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 27, 2015

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

November 1, 2014

Last Updated

April 29, 2015

Results First Posted

April 29, 2015

Record last verified: 2015-04