Psoas Density in Colorectal Cancer

Evaluating the Association Between Psoas Density Measurement on Preoperative CT Imaging and Postoperative Outcomes

Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Surgery remains the only treatment option that can reliably achieve cure from colorectal cancer and thus nearly 20,000 major bowel resections are performed for this yearly in the UK. Surgery for these cancers however carries risk of major complications and potentially death. Selecting appropriate patients for surgery remains a challenge to cancer teams.

Risk factors exist for complications after surgery for CRC, many of which can be assessed and discussed with the patient prior to surgery, so that any decision to operate is with fully informed consent from the patient. Increasing attention is being paid to a patient's frailty or fitness as one of these risk factors. Our centre has previously shown that measuring the cross-sectional area of the psoas muscle (a large muscle near the spine) from preoperative imaging could predict major complications in colorectal cancer patients (Jones 2015), however specialist software and patient height is required to make this calculation. More recently we have demonstrated that the measurement of the psoas muscle density on preoperative imaging (i.e. routine CT scans that all patients have before surgery to plan treatment), may potentially be useful to predict which patients are at most risk of a major complication (Herrod 2019). If this finding holds true when tested on a larger scale, it could be used to help surgical teams make the decision on whether to offer surgical resection, what kind of operations to perform, how to best support individuals undergoing operation and to ensure that the patient has the most information available to decide what risk they are at by having major surgery.

Study Overview

• Status: Unknown
• Conditions: Cancer of Colon

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jonathan N Lund, MD; Phone Number: 01332 340131; Email: jon.lund@nottingham.ac.uk
• Study Contact Backup: Name: James EM Blackwell, PhD BMBS; Phone Number: 01332 340131; Email: james.blackwell@nhs.net

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3DT
      • School of Graduate Entry Medicine, Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective analysis of patients (>18 years old) having undergone curative colorectal resection for cancer (between 31st Aug 2013 - 31st Aug 2019) in one if this multicentre study sites. All patients must have undergone preoperative CT scan with contrast.

Description

Inclusion Criteria:

Patient criteria:

• Having a major colorectal resection for the treatment of cancer
• Elective or emergency surgery
• Adults, defined as age ≥18 years of age (no maximum limit)
• Had a preoperative CT scan of the abdomen with contrast (portal venous phase)
• Operation performed between 31st Aug 2013 - 31st Aug 2019

Exclusion Criteria:

• Not having a preoperative CT scan with contrast

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients who underwent colorectal resection; Patients in this observational study will have undergone CT scan as routine work up prior to resection of elective colorectal cancer. Psoas muscle density will be measured (in Hounsfield units from CT images) at lumbar vertebral level L3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay.	Recorded post operative complications requiring intervention during post operative stay until initial discharge from hospital.	Through study completion, an average of 10 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative length of stay	Number of days	Through study completion, usually between 6-10 days.
Mortality	Recorded patient death	Up to 5 year follow up from operation
Post operative complications beyond hospital discharge.	Recorded post operative complications (including re-operation or recurrence) until discharge from surgical clinic or date of record review.	From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).

Collaborators and Investigators

• Sponsor: University of Nottingham

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: frailty; psoas muscle density
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: Psoas Muscle Density

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No