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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE January 1, 2014
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • 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
  • Percentage of patients developing hemorrhage [ Time Frame: 2 weeks ]
    Percentage of patients developing hemorrhage after Whipple procedure
  • Percentage of patients developing wound infection [ Time Frame: 4 weeks ]
    Percentage of patients developing wound infection after Whipple procedure
  • Mortality rate [ Time Frame: 6 weeks ]
    Mortality of patients undergoing Whipple surgery
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
postoperative complications [ Time Frame: 4 weeks ]
PANCREATIC FISTULA (ISGPF) GRADE A (Transient Fistulae) No sepsis GRADE B( Clinical Impact) discharge with drain GRADE C (Severe clinical Impact) Worrisome collection Hemorrhage Wound infection Delayed Gastric emptying Enteric leak postoperative complications like pancreatic fistula, anastomotic leakage, hemorrhage, wound infection,mortality
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
Official Title  ICMJE Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Whipple Procedure
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2019)
57
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03820583
Other Study ID Numbers  ICMJE s11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. SamiUllah, Services Hospital, Lahore
Study Sponsor  ICMJE Services Hospital, Lahore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mahmmood Ayyaz, mbbs, fcps Services Hospital, Lahore
PRS Account Services Hospital, Lahore
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP