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| Name | Class |
|---|---|
| Sir Ganga Ram Hospital | OTHER |
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A single institutional study of Pancreatic Endocrine Neoplasms over 18 years.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15070966 | Background | 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. | |
| 18515795 | Background | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Each participant was followed up for a period of 5 years |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic fistula | Gastrointestinal disorders | Systematic Assessment | A pancreatic fistula was defined as drainage of more than 30 mL of fluid per day with amylase levels at least 3 times the normal serum amylase levels from the sixth postoperative day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Gastric Emptying | Gastrointestinal disorders | Systematic Assessment | Delayed gastric emptying was defined as intolerance to oral feeds requiring nasogastric aspiration after the sixth postoperative day. |
The analysis was done from a prospectively maintained database and target followup done for a period of 5 years after surgery
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Md Tanveer Adil | Sir Ganga Ram Hospital, New Delhi, India | 0091-9830154566 | tanveer.cmc@gmail.com |
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 16924083 | Result | 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. |
| 17438169 | Result | 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. |
| Result | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 6 |
| 40 |
| 16 |
| 40 |
|
|
| Wound Infection | Infections and infestations | Systematic Assessment | Wound Infection was defined as purulent discharge from the main wound with positive culture report. |
|
| Intraabdominal Abscess | Infections and infestations | Systematic Assessment | Intraabdominal Abscess was defined as purulent fluid of any amount inside the abdomen requiring percutaneous drainage or laparotomy. |
|
| Postoperative Fever | General disorders | Systematic Assessment | Postoperative fever was defined as core body temperature more than 100 F sustained enough to require medication and search for its cause after surgery. |
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| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |