Psoas Density in Colorectal Cancer

Cancer of Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04198025
• Other study ID #: Psoas Muscle Density
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2019
• Source: University of Nottingham
• Contact: Jonathan N Lund, MD
• Phone: 01332 340131
• Email: jon.lund[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Colon
• Colonic Neoplasms

Locations

Country	Name	City	State
United Kingdom	School of Graduate Entry Medicine, Royal Derby Hospital	Derby	Derbyshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post operative length of stay	Number of days	Through study completion, usually between 6-10 days.
Secondary	Mortality	Recorded patient death	Up to 5 year follow up from operation
Secondary	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).