NCT03875612: RAVAL

Radiographic Validation of the Inferior Mesenteric Artery Tie Level in Rectal Cancer Surgery

Completed Last updated 25 September 2019

What this trial tests

trial in Rectal Cancer in 98 participants. Completed in 31 August 2019.

Timeline

12 December 2016

Primary endpoint
31 August 2019

31 August 2019

Quick facts

Lead sponsor	Umeå University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	98
Start date	12 December 2016
Primary completion	31 August 2019
Estimated completion	31 August 2019
Sites	2 locations across Sweden

Conditions studied

• Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

Umeå University

Who can join

40 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The inferior mesenteric artery is the feeding vessel for tumours in the rectum. When performing surgery for these tumours, the surgeon can cut the vessel close to the aorta or after the vessel bifurcates to the superior rectal artery and the left colic artery. A close division is termed a high tie (and the other, a low tie) and might entail a better lymph node extraction, possibly removing metastasis, but can also lead to nerve damage and e.g. bowel dysfunction.

There is no clear evidence favouring either tie level, and large amounts of data are needed to establish superiority as any effects is likely to be small. One such method is to use national registries with prospectively collected data on e.g. level of tie and cancer relapse. However, it is not always easy to determine the level of tie while in the operating room and registries might also contain erroneous data.

In order to determine the validity of such data, comparisons to objective measures are needed. This study is an attempt to correlate radiographic imaging to the suggested tie level, as indicated by the surgeon in the operative report and by the nationwide Swedish Colorectal Cancer Registry. If the registry variable tie level has a high correlation with imagining, researchers can more reliably use the registry to establish the benefits and drawbacks with high tie in rectal cancer surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Discrepancy between surgeon and radiological assessment of ligation level of the inferior mesenteric artery in patients operated for rectal cancer-impacting registry-based research and surgical practice.
   Wikner F, Matthiessen P, Sörelius K, Legrell P, et al · · 2021 · cited 5× · PMID 33849560 · DOI 10.1186/s12957-021-02222-5