NCT05014425

Brief Summary

Postoperative pancreatic fistula (POPF) following pancreaticoduodenectomy is considered a life-threatening complication. This study was designed to analyze the risk factors for development of such fistula in a tertiary care center (Al-Rajhi Liver Hospital/ Assiut University).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

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, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

4 years

First QC Date

August 14, 2021

Last Update Submit

August 14, 2021

Conditions

Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

  • Development of pancreatic fistula following pancreaticoduodenectomy

    Analysis of risk factors for development of pancreatic fistula following pancreaticoduodenectomy

    Baseline

Interventions

pancreaticoduodenectomyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients underwent pancreaticoduodenectomy at Al-Rajhi liver Hospital, Assiut university from January 2017 to December 2020

You may qualify if:

  • All patients underwent pancreaticoduodenectomy for pancreatic cancer

You may not qualify if:

  • All types of pancreatic resection other than pancreaticoduodenectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 14, 2021

First Posted

August 20, 2021

Study Start

January 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 20, 2021

Record last verified: 2021-08