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

• Sponsor: Medical College and Hospital Kolkata (Other)
• Overall Status: Completed
• CT.gov ID: NCT02400996
• Collaborator: Sir Ganga Ram Hospital (Other)
• Enrollment: 40
• Duration (Months): 44.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

• 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: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pathological reports and Prooperative CAT Scan showing Endocrine Pancreatic Tumours

Exclusion Criteria:

• Nonendocrine Pancreatic Tumours

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medical College and Hospital Kolkata
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Md Tanveer Adil, Fellow, Sir Ganga Ram Hospital
• ClinicalTrials.gov Identifier: NCT02400996
• Other Study ID Numbers: SGRH-SGLT-MTA
• First Posted: Mar 27, 2015
• Last Update Posted: Apr 29, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Md Tanveer Adil, Fellow, Sir Ganga Ram Hospital: Endocrine Pancreas; Pancreatic Endocrine Neoplasm
• Additional relevant MeSH terms: Neoplasms; Endocrine Gland Neoplasms; Adenoma, Islet Cell

Study Results

Participant Flow

Recruitment Details	An analysis from a prospectively maintained database of patients was done 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

Arm/Group Title	Patients Operated for Pancreatic Endocrine Neoplasms
Arm/Group Description	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.
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Patients Operated for Pancreatic Endocrine Neoplasms
Arm/Group Description	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.
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.6 (15.52)
Sex: Female, Male (Count of Participants)
Female	18 45%
Male	22 55%
Region of Enrollment (participants) [Number]
India	40 100%

Outcome Measures

1. Primary Outcome

Title	Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
Description	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.
Time Frame	Each participant was followed up for a period of 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Operated for Pancreatic Endocrine Neoplasms
Arm/Group Description	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.
Measure Participants	40
Nonfunctioning Tumours	28 70%
Functioning Tumours	12 30%
Benign Tumours	22 55%
Malignant Tumours	18 45%

Adverse Events

Time Frame	Complications were noted within the hospital admission. Postoperative mortality recorded as death within the same hospital admission or within 30 days of surgery. Follow up was done at 3 and 6 months and then at 6 monthly intervals for 5 years.
Adverse Event Reporting Description	The type of surgery performed, operative findings, postoperative hospital stay and complications were recorded. Postoperative mortality was recorded and followup done for disease recurrence or mortality.
Arm/Group Title	Pancreatic Endocrine Neoplasms
Arm/Group Description	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.
All Cause Mortality
	Pancreatic Endocrine Neoplasms
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pancreatic Endocrine Neoplasms
	Affected / at Risk (%)	# Events
Total	6/40 (15%)
Gastrointestinal disorders
Pancreatic fistula	6/40 (15%)	6
Other (Not Including Serious) Adverse Events
	Pancreatic Endocrine Neoplasms
	Affected / at Risk (%)	# Events
Total	16/40 (40%)
Gastrointestinal disorders
Delayed Gastric Emptying	8/40 (20%)	8
General disorders
Postoperative Fever	2/40 (5%)	2
Infections and infestations
Wound Infection	4/40 (10%)	4
Intraabdominal Abscess	2/40 (5%)	2

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.