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Completed

NCT Number: NCT03820583

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

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.

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Key information

Conditions

Whipple Procedure Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whipple procedure

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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