Role of Pre-operative CPET in Pancreatoduodenectomy

Pancreas Cancer Clinical Trial

— WHIPPLES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06068452
• Other study ID #: 2021/010
• Secondary ID: 284588
• Status: Completed
• Start date: March 24, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: June 2024
• Source: East Lancashire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms
• Periampullary Carcinoma

Locations

Country	Name	City	State
United Kingdom	East Lancashire Hospitals NHS Trust	Blackburn	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
East Lancashire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Chandrabalan 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) — View Citation

Junejo 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. — View Citation

Levett 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 guidel — View Citation

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	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.	90 days