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Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center

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ClinicalTrials.gov Identifier: NCT03820583
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. SamiUllah, Services Hospital, Lahore

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Whipple Procedure Procedure: Whipple Procedure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients undergoing Whipple procedure due to pancreatic tumor were included in the study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

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Arms and Interventions
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Intervention Details:
  • Procedure: Whipple Procedure
    Patients underwent Whipple procedure for pancreatic tumors. The procedure commenced with rooftop incision. then layers of abdomen dissected to reach the peritoneum. Then Duodenum dissected out along with pancreas and common bile duct. After rescetion of these structures the anatomy of the tract restored with three anastomosis namely pancreaticojejunostomy, gastrojejunostomy and choledochojejunostomy/hepaticojejunostomy.

Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Percentage of patients developing hemorrhage [ Time Frame: 2 weeks ]
    Percentage of patients developing hemorrhage after Whipple procedure

  3. Percentage of patients developing wound infection [ Time Frame: 4 weeks ]
    Percentage of patients developing wound infection after Whipple procedure

  4. Mortality rate [ Time Frame: 6 weeks ]
    Mortality of patients undergoing Whipple surgery


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820583


Locations
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Pakistan
Services hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Services Hospital, Lahore
Investigators
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Study Director: Mahmmood Ayyaz, mbbs, fcps Services Hospital, Lahore
More Information
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Responsible Party: Dr. SamiUllah, Principle investigator, Services Hospital, Lahore
ClinicalTrials.gov Identifier: NCT03820583    
Other Study ID Numbers: s11
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. SamiUllah, Services Hospital, Lahore:
Whipple procedure, pancreatic carcinoma, biliary stenting,