Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2025-12-17 @ 6:28 AM
Study NCT ID:
NCT06068452
Status:
None
Last Update Posted:
2024-06-18 00:00:00
First Post:
2023-09-21 00:00:00
Brief Title:
Role of Pre-operative CPET in Pancreatoduodenectomy
Sponsor:
East Lancashire Hospitals NHS Trust
Organization:
East Lancashire Hospitals NHS Trust
Study Overview
Official Title:
Clinical Effectiveness of Pre-operative Cardiopulmonary Exercise Testing (CPET) in Predicting Post-operative Morbidity and Mortality After Pancreatoduodenectomy- A Retrospective Cohort Study
Status:
None
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WHIPPLES
Brief Summary:
Retrospective analysis of prospectively maintained database. A clinical database has been prospectively maintained by the investigators, with details of pancreatic resections since January 2016. It includes pre-operative details, details of multidisciplinary team (MDT) meeting, details of pre-operative biliary stenting, intra-operative details, post-operative morbidity and mortality, details of histopathological diagnosis, recurrence and survival. Data was collected onto the database (excel sheet) from trust data software, clinic letters, Somerset Cancer registry and clinical portal.
Specific CPET data to be collected:
1. Exercise induced ST ischaemia- yes/no
2. VO2 peak: actual and predicted
3. Anaerobic threshold
4. VE/VCO2
5. Pulmonary function test- normal/ obstructive/ restrictive
6. Duration of pedalling bike
7. 30 day predicted risk
8. Completed the test - yes/no
9. Reason for incomplete test The CPET specific data will be collated from clinic letters, MDT meeting outcomes and CPET reports stored in hospital drive (access limited to anaesthetists only presently).
Data analysis will be done using IBM SPSS version 25. Investigators plan to use parametric and non-parametric tests and binary logistic regression analyses to compare predicted to actual mortality and morbidity, between the patients who have had CPET and those who have not.
6 STUDY SETTING: This is a single centre study, to be done at, Royal Blackburn Hospital, East Lancashire Hospitals NHS trust, a District general Hospital in North of England. The study will be carried out in the department of General and HPB surgery, in liaise with Department of anaesthesia. This is the HPB referral centre for Lancashire and South Cumbria and incorporates patients referred for pancreatic surgery from three hospital trusts (Lancashire Teaching, University Hospital Morecambe Bay and Blackpool Teaching Hospitals). The data will be stored in the trust computer system, using a password protected excel sheet. The investigators responsible for the study only, will be provided with access to the database.
Specific CPET data to be collected:
1. Exercise induced ST ischaemia- yes/no
2. VO2 peak: actual and predicted
3. Anaerobic threshold
4. VE/VCO2
5. Pulmonary function test- normal/ obstructive/ restrictive
6. Duration of pedalling bike
7. 30 day predicted risk
8. Completed the test - yes/no
9. Reason for incomplete test The CPET specific data will be collated from clinic letters, MDT meeting outcomes and CPET reports stored in hospital drive (access limited to anaesthetists only presently).
Data analysis will be done using IBM SPSS version 25. Investigators plan to use parametric and non-parametric tests and binary logistic regression analyses to compare predicted to actual mortality and morbidity, between the patients who have had CPET and those who have not.
6 STUDY SETTING: This is a single centre study, to be done at, Royal Blackburn Hospital, East Lancashire Hospitals NHS trust, a District general Hospital in North of England. The study will be carried out in the department of General and HPB surgery, in liaise with Department of anaesthesia. This is the HPB referral centre for Lancashire and South Cumbria and incorporates patients referred for pancreatic surgery from three hospital trusts (Lancashire Teaching, University Hospital Morecambe Bay and Blackpool Teaching Hospitals). The data will be stored in the trust computer system, using a password protected excel sheet. The investigators responsible for the study only, will be provided with access to the database.
Detailed Description:
Retrospective analysis of prospectively maintained database A clinical database has been prospectively maintained by the investigators with details of pancreatic resections since January 2016 It includes pre-operative details details of multidisciplinary team MDT meeting details of pre-operative biliary stenting intra-operative details post-operative morbidity and mortality details of histopathological diagnosis recurrence and survival Data was collected onto the database excel sheet from trust data software clinic letters Somerset Cancer registry and clinical portal
Specific CPET data to be collected
1 Exercise induced ST ischaemia- yesno
2 VO2 peak actual and predicted
3 Anaerobic threshold
4 VEVCO2
5 Pulmonary function test- normal obstructive restrictive
6 Duration of pedalling bike
7 30 day predicted risk
8 Completed the test - yesno
9 Reason for incomplete test The CPET specific data will be collated from clinic letters MDT meeting outcomes and CPET reports stored in hospital drive access limited to anaesthetists only presently
Data analysis will be done using IBM SPSS version 25 Investigators plan to use parametric and non-parametric tests and binary logistic regression analyses to compare predicted to actual mortality and morbidity between the patients who have had CPET and those who have not
6 STUDY SETTING This is a single centre study to be done at Royal Blackburn Hospital East Lancashire Hospitals NHS trust a District general Hospital in North of England The study will be carried out in the department of General and HPB surgery in liaise with Department of anaesthesia This is the HPB referral centre for Lancashire and South Cumbria and incorporates patients referred for pancreatic surgery from three hospital trusts Lancashire Teaching University Hospital Morecambe Bay and Blackpool Teaching Hospitals The data will be stored in the trust computer system using a password protected excel sheet The investigators responsible for the study only will be provided with access to the database
Specific CPET data to be collected
1 Exercise induced ST ischaemia- yesno
2 VO2 peak actual and predicted
3 Anaerobic threshold
4 VEVCO2
5 Pulmonary function test- normal obstructive restrictive
6 Duration of pedalling bike
7 30 day predicted risk
8 Completed the test - yesno
9 Reason for incomplete test The CPET specific data will be collated from clinic letters MDT meeting outcomes and CPET reports stored in hospital drive access limited to anaesthetists only presently
Data analysis will be done using IBM SPSS version 25 Investigators plan to use parametric and non-parametric tests and binary logistic regression analyses to compare predicted to actual mortality and morbidity between the patients who have had CPET and those who have not
6 STUDY SETTING This is a single centre study to be done at Royal Blackburn Hospital East Lancashire Hospitals NHS trust a District general Hospital in North of England The study will be carried out in the department of General and HPB surgery in liaise with Department of anaesthesia This is the HPB referral centre for Lancashire and South Cumbria and incorporates patients referred for pancreatic surgery from three hospital trusts Lancashire Teaching University Hospital Morecambe Bay and Blackpool Teaching Hospitals The data will be stored in the trust computer system using a password protected excel sheet The investigators responsible for the study only will be provided with access to the database
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 284588 | OTHER | Health Research Authority | None |