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

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ClinicalTrials.gov Identifier: NCT02400996
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
Sir Ganga Ram Hospital
Information provided by (Responsible Party):
Md Tanveer Adil, Sir Ganga Ram Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pancreatic Endocrine Neoplasms
Enrollment 40
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
Pre-assignment Details  
Arm/Group Title Patients Operated for Pancreatic Endocrine Neoplasms
Hide 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
Arm/Group Title Patients Operated for Pancreatic Endocrine Neoplasms
Hide 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 Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
48.6  (15.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
18
  45.0%
Male
22
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 40 participants
40
1.Primary Outcome
Title Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Operated for Pancreatic Endocrine Neoplasms
Hide 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 Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
Nonfunctioning Tumours 28
Functioning Tumours 12
Benign Tumours 22
Malignant Tumours 18
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
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pancreatic Endocrine Neoplasms
Affected / at Risk (%) # Events
Total   6/40 (15.00%)    
Gastrointestinal disorders   
Pancreatic fistula  [1]  6/40 (15.00%)  6
Indicates events were collected by systematic assessment
[1]
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
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pancreatic Endocrine Neoplasms
Affected / at Risk (%) # Events
Total   16/40 (40.00%)    
Gastrointestinal disorders   
Delayed Gastric Emptying  [1]  8/40 (20.00%)  8
General disorders   
Postoperative Fever  [2]  2/40 (5.00%)  2
Infections and infestations   
Wound Infection  [3]  4/40 (10.00%)  4
Intraabdominal Abscess  [4]  2/40 (5.00%)  2
Indicates events were collected by systematic assessment
[1]
Delayed gastric emptying was defined as intolerance to oral feeds requiring nasogastric aspiration after the sixth postoperative day.
[2]
Postoperative fever was defined as core body temperature more than 100 F sustained enough to require medication and search for its cause after surgery.
[3]
Wound Infection was defined as purulent discharge from the main wound with positive culture report.
[4]
Intraabdominal Abscess was defined as purulent fluid of any amount inside the abdomen requiring percutaneous drainage or laparotomy.
The analysis was done from a prospectively maintained database and target followup done for a period of 5 years after surgery
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Md Tanveer Adil
Organization: Sir Ganga Ram Hospital, New Delhi, India
Phone: 0091-9830154566
EMail: tanveer.cmc@gmail.com
Layout table for additonal information
Responsible Party: Md Tanveer Adil, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT02400996     History of Changes
Other Study ID Numbers: SGRH-SGLT-MTA
First Submitted: March 23, 2015
First Posted: March 27, 2015
Results First Submitted: March 26, 2015
Results First Posted: April 29, 2015
Last Update Posted: April 29, 2015