Clinical trial NCT02400996: An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms
Official title: A Single Centre Analysis of Clinical Characteristics and Treatment of Endocrine Pancreatic Tumours.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Endocrine Neoplasms
Keywords: Endocrine Pancreas
Pancreatic Endocrine Neoplasm
Lead sponsor: Medical College and Hospital Kolkata
Sponsor class: OTHER
Collaborators: name: Sir Ganga Ram Hospital
First posted: 2015-03-27
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: Inclusion Criteria:

* Pathological reports and Prooperative CAT Scan showing Endocrine Pancreatic Tumours

Exclusion Criteria:

* Nonendocrine Pancreatic Tumours

Primary outcomes:
measure: Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
timeFrame: Each participant was followed up for a period of 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sir Ganga Ram Hospital, New Delhi
name: Md Tanveer Adil
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Ganga Ram Hospital, New Delhi
name: Raghavendra Nagaraja
role: STUDY_DIRECTOR
affiliation: Sir Ganga Ram Hospital, New Delhi
name: Vibha Varma
role: STUDY_DIRECTOR
affiliation: Sir Ganga Ram Hospital, New Delhi
name: Naimish Mehta
role: STUDY_DIRECTOR
affiliation: Sir Ganga Ram Hospital, New Delhi
name: Vinay Kumaran
role: STUDY_DIRECTOR
affiliation: Sir Ganga Ram Hospital, New Delhi
name: Samiran Nundy
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.