NCT03820583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

5 years

First QC Date

January 25, 2019

Last Update Submit

January 29, 2019

Conditions

Keywords

Whipple procedure, pancreatic carcinoma, biliary stenting,

Outcome Measures

Primary Outcomes (4)

  • 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

  • Percentage of patients developing hemorrhage

    Percentage of patients developing hemorrhage after Whipple procedure

    2 weeks

  • Percentage of patients developing wound infection

    Percentage of patients developing wound infection after Whipple procedure

    4 weeks

  • Mortality rate

    Mortality of patients undergoing Whipple surgery

    6 weeks

Interventions

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.

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unresectable tumors
  • unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mahmmood Ayyaz, mbbs, fcps

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients undergoing Whipple procedure due to pancreatic tumor were included in the study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

January 1, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations