NCT04395898

Brief Summary

ABSTRACT BACKGROUND Pancreaticoduodenectomy (PD) plays an integral part in the management of pancreatic, periampullary and duodenal cancers along with few other pathologies of this region. Despite advances in surgery PD continues to have significant morbidity and noteworthy mortality. The aim of this study is to provide an in-depth report on the patient characteristics, indications and the outcomes of PD) in a tertiary cancer hospital in Pakistan. MATERIALS AND METHODS: The study population included patients who underwent PD between January 1st 2014 and march 31st 2019, at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC) in Pakistan. The Data was retrospectively analyzed from the Hospital Information System (HIS), which is a prospectively maintained patient electronic database of SKMCH\&RC. Patient characteristics, procedural details and post-operative outcomes according to internationally accepted definitions were reported. KEYWORDS: Whipple's procedure, Pancreaticoduodenectomy, Pancreaticogastrostomy, lower middle income, pancreatic fistula, periampullary cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 11, 2020

Last Update Submit

May 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival analysis

    disease free and overall survival

    4 years

Secondary Outcomes (2)

  • Morbidity

    30 days

  • recurrence

    4 years

Interventions

Whipple's procedure

Eligibility Criteria

Age19 Years - 78 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pancreatic cancer.

You may qualify if:

  • all patients whose surgeries were done from January 2014 to March 2019

You may not qualify if:

  • None as such

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaukat Khanam Memorial Cancer Hospital and Research Center

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

  • Farah Rasheed

    Clinical research officer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow in Surgical Oncology

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 20, 2020

Study Start

January 1, 2020

Primary Completion

March 4, 2020

Study Completion

March 15, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

will see

Shared Documents
STUDY PROTOCOL
Time Frame
will see
Access Criteria
that will be discussed with the hospital IRB and later we will see wether it has to be shared

Locations