Role of Pre-operative CPET in Pancreatoduodenectomy

NCT06068452 | Completed

• 2 other identifiers: 2021/010284588
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer; Periampullary Carcinoma

Outcome Measures

Primary Outcomes (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

  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 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

  90 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• East Lancashire Hospitals NHS Trust: lead

Study Sites (1)

East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 30724356 RESULT

• 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 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.

  PMID: 29452805 RESULT

• 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). 2013 Nov;15(11):899-907. doi: 10.1111/hpb.12060. Epub 2013 Feb 20.

  PMID: 23458160 RESULT

• 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: 10.1245/s10434-014-3493-0. Epub 2014 Jan 30.

  PMID: 24477709 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Asma Ms Sultana

  East Lancashire NHS Hospitals Trust

  PRINCIPAL INVESTIGATOR

• Meghana Ms Taggarsi

  East Lancashire NHS Hospitals Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 5, 2023
• Study Start: March 24, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)