Pancreas CancerWHIPPLESNCT06068452
Role of Pre-operative CPET in Pancreatoduodenectomy
An observational study of Pancreas Cancer and Periampullary Carcinoma, run by East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Cancer, Periampullary Carcinoma
- How many people
- 113 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Mar 2021to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be identified by database search from April 2016 to March 2020, online records, clinical portal, Somerset cancer registry. Duplicates will be removed, cases will be screened. All the patients who have undergone pancreatic resections for preoperative diagnosis of cholangiocarcinoma, duodenal and periampullary tumors and pancreatic tumors, which includes pancreatoduodenectomy, during the study period, irrespective of age and comorbidities will be included in the study. The patients who have undergone pancreatic resections other than pancreatoduodenectomy will be excluded. P-Possum and CPET specific data will be collected retrospectively, for predicted morbidity and mortality.
Who may be able to join
- 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)
Who cannot join
- Duodenal or gastric resections, not in conjunction with pancreatic resections
- Distal pancreatectomy
- Partial excision
- Enucleation of lesions
- Open and close when inoperable
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Lancashire Hospitals NHS Trust
Blackburn, Lancashire, BB2 3HH
About this study
Official title: Clinical Effectiveness of Pre-operative Cardiopulmonary Exercise Testing (CPET) in Predicting Post-operative Morbidity and Mortality After Pancreatoduodenectomy- A Retrospective Cohort Study
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.
Read the 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:
- 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.
- Conditions
- Pancreas Cancer, Periampullary Carcinoma
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 30 days
Secondary outcomes (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
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start24 Mar 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Lancashire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghana Taggarsi, East Lancashire Hospitals NHS Trust
- Investigators
- Asma Ms Sultana, Principal investigator, East Lancashire NHS Hospitals TrustMeghana Ms Taggarsi, Principal investigator, East Lancashire NHS Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068452
- Sponsor's protocol ID
- 2021/010
- Other IDs
- 284588
- Acronym
- WHIPPLES
- Status last verified
- Jun 2024
- First submitted
- 21 Sep 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consent not obtained from participants for use of their data in future research
Publications
Wu JM, Kuo TC, Chen HA, Wu CH, Lai SR, Yang CY, Hsu SY, Ho TW, Liao WC, Tien YW. Randomized trial of oral versus enteral feeding for patients with postoperative pancreatic fistula after pancreatoduodenectomy. Br J Surg. 2019 Feb;106(3):190-198. doi: 10.1002/bjs.11087.
PubMed 30724356Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.
PubMed 29452805Chandrabalan VV, McMillan DC, Carter R, Kinsella J, McKay CJ, Carter CR, Dickson EJ. Pre-operative cardiopulmonary exercise testing predicts adverse post-operative events and non-progression to adjuvant therapy after major pancreatic surgery. HPB (Oxford). 2013 Nov;15(11):899-907. doi: 10.1111/hpb.12060. Epub 2013 Feb 20.
PubMed 23458160Junejo MA, Mason JM, Sheen AJ, Bryan A, Moore J, Foster P, Atkinson D, Parker MJ, Siriwardena AK. Cardiopulmonary exercise testing for preoperative risk assessment before pancreaticoduodenectomy for cancer. Ann Surg Oncol. 2014 Jun;21(6):1929-36. doi: 10.1245/s10434-014-3493-0. Epub 2014 Jan 30.
PubMed 24477709
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Pre-operative Cardiopulmonary Exercise Testing (CPET) in Predicting Post-operative Morbidity and Mortality After Pancreatoduodenectomy- A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06068452
- Acronym / sponsor ID
- WHIPPLES / 2021/010
- Conditions
- Pancreas Cancer, Periampullary Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- East Lancashire Hospitals NHS TrustUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be identified by database search from April 2016 to March 2020, online records, clinical portal, Somerset cancer registry. Duplicates will be removed, cases will be screened. All the patients who have undergone pancreatic resections for preoperative diagnosis of cholangiocarcinoma, duodenal and periampullary tumors and pancreatic tumors, which includes pancreatoduodenectomy, during the study period, irrespective of age and comorbidities will be included in the study. The patients who have undergone pancreatic resections other than pancreatoduodenectomy will be excluded. P-Possum and CPET specific data will be collected retrospectively, for predicted morbidity and mortality.
Key inclusion criteria (5 listed)
- All pancreatic resections during the study period, performed for:
- All the patients in the database who have undergone Whipple (pancreatoduodenectomy)
Key exclusion criteria (5 listed)
- Duodenal or gastric resections, not in conjunction with pancreatic resections
- Distal pancreatectomy
- Partial excision
- Enucleation of lesions
- Open and close when inoperable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Results publication: PubMed 30724356Wu JM, Kuo TC, Chen HA, Wu CH, Lai SR, Yang CY, Hsu SY, Ho TW, Liao WC, Tien YW. Randomized trial of oral versus enteral feeding for patients with postoperative pancreatic fistula after pancreatoduodenectomy. Br J Surg. 2019 Feb;106(3):190-198. doi: 10.1002/bjs.11087.
- Results publication: PubMed 29452805Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.
- Results publication: PubMed 23458160Chandrabalan VV, McMillan DC, Carter R, Kinsella J, McKay CJ, Carter CR, Dickson EJ. Pre-operative cardiopulmonary exercise testing predicts adverse post-operative events and non-progression to adjuvant therapy after major pancreatic surgery. HPB (Oxford). 2013 Nov;15(11):899-907. doi: 10.1111/hpb.12060. Epub 2013 Feb 20.
- Results publication: PubMed 24477709Junejo MA, Mason JM, Sheen AJ, Bryan A, Moore J, Foster P, Atkinson D, Parker MJ, Siriwardena AK. Cardiopulmonary exercise testing for preoperative risk assessment before pancreaticoduodenectomy for cancer. Ann Surg Oncol. 2014 Jun;21(6):1929-36. doi: 10.1245/s10434-014-3493-0. Epub 2014 Jan 30.
- Individual participant dataSharing planned: No. Consent not obtained from participants for use of their data in future research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Ms Sultana principal investigator
East Lancashire NHS Hospitals Trust
Meghana Ms Taggarsi principal investigator
East Lancashire NHS Hospitals Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Periampullary Carcinoma, run by East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06068452, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.