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WHIPPLES: Role of Pre-operative CPET in Pancreatoduodenectomy

Sponsor
East Lancashire Hospitals NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT06068452
Collaborator
(none)
113
Enrollment
1
Location
11.7
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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- 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    113 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Effectiveness of Pre-operative Cardiopulmonary Exercise Testing (CPET) in Predicting Post-operative Morbidity and Mortality After Pancreatoduodenectomy- A Retrospective Cohort Study
    Actual Study Start Date :
    Mar 24, 2021
    Actual Primary Completion Date :
    Mar 15, 2022
    Actual Study Completion Date :
    Mar 15, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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 [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 Outcome Measures

    1. 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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 East Lancashire Hospitals NHS Trust Blackburn Lancashire United Kingdom BB2 3HH

    Sponsors and Collaborators

    • East Lancashire Hospitals NHS Trust

    Investigators

    • Principal Investigator: Asma Ms Sultana, East Lancashire NHS Hospitals Trust
    • Principal Investigator: Meghana Ms Taggarsi, East Lancashire NHS Hospitals Trust

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Meghana Taggarsi, Principal Investigator, East Lancashire Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT06068452
    Other Study ID Numbers:
    • 2021/010
    • 284588
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 5, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Oct 5, 2023