- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820583
Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
January 29, 2019 updated by: Dr. SamiUllah, Services Hospital, Lahore
The study was conducted in tertiary care hospital of Lahore.
Patient undergoing Whipple procedure were studied by compiling demographic details of the patients, common presenting symptoms, various indications for Whipple's procedure, the cofactors which affect the procedures outcome and morbidity and mortality of the patients.
Study Overview
Detailed Description
This study was performed by collecting data through predesigned questionnaire about patients undergoing Whipple's procedure from operation theatres and medical record section.
Those patients, whose tumor was unresectable and undergone palliative surgical procedures were excluded from the study.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Services Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients of both sexes with age ranging from 20 years to 70 years
- patients with pancreatic tumors
- patients with adequate cardiorespiratory reserves to be fit for prolong general anesthesia
Exclusion Criteria:
- unresectable tumors
- unfit for surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients developing pancreatic fistula
Time Frame: 4 weeks
|
Percentage of patients developing pancreatic fistula (pancreatic juice collected in drain rich in amylase) after Whipple procedure Enteric leak postoperative complications like pancreatic fistula, anastomotic leakage, hemorrhage, wound infection,mortality
|
4 weeks
|
Percentage of patients developing hemorrhage
Time Frame: 2 weeks
|
Percentage of patients developing hemorrhage after Whipple procedure
|
2 weeks
|
Percentage of patients developing wound infection
Time Frame: 4 weeks
|
Percentage of patients developing wound infection after Whipple procedure
|
4 weeks
|
Mortality rate
Time Frame: 6 weeks
|
Mortality of patients undergoing Whipple surgery
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
January 25, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 29, 2019
Study Record Updates
Last Update Posted (Actual)
January 31, 2019
Last Update Submitted That Met QC Criteria
January 29, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- s11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Whipple Procedure
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University Hospitals Cleveland Medical CenterEmory UniversityRecruitingAcute Pain | Distal Pancreatectomy | Whipple ProcedureUnited States
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Assistance Publique Hopitaux De MarseilleCompletedWhipple InfectionFrance
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