Reoperation After Pancreaticoduodenectomy
Surgical Intervention After Pancreaticoduodenectomy: Incidence, Indications, Risk Factors and Outcome
1 other identifier
observational
1,000
0 countries
N/A
Brief Summary
The aim of this study is to outline the incidence of early and late reoperation after PD, examine the risk factors for early surgical intervention and its impact on the surgical outcome, hospital stay, diseases recurrence and patient survival, address variable indications for late readmission and reoperation after PD and its impact on patient survival and disease recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2000
Longer than P75 for all trials
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, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 10, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedMay 14, 2020
May 1, 2020
18.3 years
May 10, 2020
May 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient survival
The duration between surgical intervention to patient death
2-20 years after surgery
Tumor recurrence
Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.
2-20 years
Secondary Outcomes (3)
Hospital stay after reoperation
10-90 days after reoperation
Morbidity after reoperation
10-90 days after reoperation
Risk factors for surgical reoperation
Before surgical intervention
Study Arms (2)
Reoperation group
The group of patients who underwent pancreaticduodenectomy for management of periampullary tumors and required surgical reintervention afterwards for management of procedure-related complications as pancreatic fistula, bleeding, abdominal collection, biliary fistula, gastric fistula.
No reoperation group
The group of patients who underwent pancreaticoduodenectomy for management of periampullary tumors and did not require surgical reintervention.
Interventions
Mandatory surgical management of complications after pancreatico-duodenectomy through peritoneal lavage, draiange, repair of fistula, completion pancreatectomy, control of bleeding, bowel resection, and feeding jejunostomy.
Eligibility Criteria
This is a retrospective cohort study of all patients who underwent PD for periampullary malignant lesions in the duration between January 2000 and May 2018. Preoperative assessment was performed by clinical examination and detailed laboratory investigations. Assessment of local extension of the tumor and metastatic work-up was performed by pelvi-abdominal ultrasound (US), triphasic abdominal computerized tomography (CT) with angiographic assessment of the surrounding vessels, bone survey, and chest X-ray. Preoperative endoscopic retrograde cholangiopancreatography (ERCP) for preoperative biliary drainage was performed in selected cases
You may qualify if:
- all patients who underwent pancreaticoduodenectomy for periampullary malignant lesions in the duration between January 2000 and May 2018
You may not qualify if:
- Pancreaticoduodenectomy performed for benign tumors, recurrent malignant tumors, chronic pancreatitis, or inflammatory strictures were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ayman El Nakeeb, md
Professor of Surgery, Gastrointestinal Surgical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of general surgery
Study Record Dates
First Submitted
May 10, 2020
First Posted
May 14, 2020
Study Start
January 1, 2000
Primary Completion
May 1, 2018
Study Completion
August 1, 2020
Last Updated
May 14, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
The data will be prepared as a research paper and the cohort results will be published in a scientific journal.