Role of Pre-operative CPET in Pancreatoduodenectomy

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.

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Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Periampullary Carcinoma

Sex eligibility

All sexes

Study type

Observational

Primary location

East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

About this study

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:

Exercise induced ST ischaemia- yes/no
VO2 peak: actual and predicted
Anaerobic threshold
VE/VCO2
Pulmonary function test- normal/ obstructive/ restrictive
Duration of pedalling bike
30 day predicted risk
Completed the test - yes/no
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All pancreatic resections during the study period, performed for:

Cholangiocarcinoma
Duodenal and periampullary tumors
Pancreatic tumors
All the patients in the database who have undergone Whipple (pancreatoduodenectomy)

Exclusion criteria

Duodenal or gastric resections, not in conjunction with pancreatic resections
Distal pancreatectomy
Partial excision
Enucleation of lesions
Open and close when inoperable

Treatment and study plan

Primary outcomes

Cardiopulmonary Exercise Testing (CPET)/ Portsmouth - Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM) predicted mortality versus actual 30 day mortality

Time frame: 30 days

Primary outcome is to compare predicted mortality by cardiopulmonary Exercise Testing (CPET)/ Portsmouth - Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-Possum) score versus actual 30 day mortality, post-operatively.

P-POSSUM is a scoring system for general elective and emergency surgeries which takes into account various physiological and operative parameters to calculate risk of morbidity and mortality in terms of percentages. The risk can range between 0 to 100%. The higher the percentage worse is the predicted outcome.

Secondary outcomes

Cardiopulmonary Exercise Testing (CPET) / Portsmouth - Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM) predicted morbidity versus actual post-operative morbidity

Time frame: 90 days

Secondary outcome is to compare predicted morbidity by cardiopulmonary Exercise Testing (CPET) /Portsmouth - Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-Possum) score versus actual morbidity, post-operatively.

P-POSSUM is a scoring system for general elective and emergency surgeries which takes into account various physiological and operative parameters to calculate risk of morbidity and mortality in terms of percentages. The risk can range between 0 to 100%. The higher the percentage worse is the predicted outcome.

Sponsors and collaborators

Lead sponsor

East Lancashire Hospitals NHS Trust

Other

Registry information

Official study title

Clinical Effectiveness of Pre-operative Cardiopulmonary Exercise Testing (CPET) in Predicting Post-operative Morbidity and Mortality After Pancreatoduodenectomy- A Retrospective Cohort Study

Acronym: WHIPPLES

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Oct 5, 2023
Registry last updated: Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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