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

Whipple Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820583
• Other study ID #: s11
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Whipple Procedure

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Services hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients developing pancreatic fistula	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
Primary	Percentage of patients developing hemorrhage	Percentage of patients developing hemorrhage after Whipple procedure	2 weeks
Primary	Percentage of patients developing wound infection	Percentage of patients developing wound infection after Whipple procedure	4 weeks
Primary	Mortality rate	Mortality of patients undergoing Whipple surgery	6 weeks