Trial Outcomes & Findings for An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms (NCT NCT02400996)
NCT ID: NCT02400996
Last Updated: 2015-04-29
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
Each participant was followed up for a period of 5 years
Results posted on
2015-04-29
Participant Flow
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
Participant milestones
| Measure |
Patients Operated for 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.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms
Baseline characteristics by cohort
| Measure |
Patients Operated for Pancreatic Endocrine Neoplasms
n=40 Participants
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.
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Age, Continuous
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48.6 years
STANDARD_DEVIATION 15.52 • n=99 Participants
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Sex: Female, Male
Female
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18 Participants
n=99 Participants
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Sex: Female, Male
Male
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22 Participants
n=99 Participants
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Region of Enrollment
India
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40 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Each participant was followed up for a period of 5 yearsOf 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.
Outcome measures
| Measure |
Patients Operated for Pancreatic Endocrine Neoplasms
n=40 Participants
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.
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|---|---|
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Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
Nonfunctioning Tumours
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28 participants
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Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
Functioning Tumours
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12 participants
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Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
Benign Tumours
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22 participants
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Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
Malignant Tumours
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18 participants
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Adverse Events
Pancreatic Endocrine Neoplasms
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pancreatic Endocrine Neoplasms
n=40 participants at risk
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.
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|---|---|
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Gastrointestinal disorders
Pancreatic fistula
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15.0%
6/40 • Number of events 6 • 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.
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.
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Other adverse events
| Measure |
Pancreatic Endocrine Neoplasms
n=40 participants at risk
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.
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|---|---|
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Gastrointestinal disorders
Delayed Gastric Emptying
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20.0%
8/40 • Number of events 8 • 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.
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.
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Infections and infestations
Wound Infection
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10.0%
4/40 • Number of events 4 • 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.
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.
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|
Infections and infestations
Intraabdominal Abscess
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5.0%
2/40 • Number of events 2 • 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.
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.
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General disorders
Postoperative Fever
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5.0%
2/40 • Number of events 2 • 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.
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.
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Additional Information
Md Tanveer Adil
Sir Ganga Ram Hospital, New Delhi, India
Phone: 0091-9830154566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place