The Value of CE-LUS During Robot-assisted Surgery for Primary Colorectal Cancer

NCT02457390 | Completed DMC

• 1 other identifier: 20140154
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic ultrasound examination performed during surgery for primary cancer of the colon and rectum (CRC) has been shown to be able to detect liver metastasis that are not recognized by conventional computer tomography (CT scan) prior to surgery. Today most of the colorectal cancer resections are performed by laparoscopy, but robotic technology is gradually developed in an attempt to overcome some of the limitations characterized by laparoscopy. The use of contrast enhanced laparoscopic ultrasound examination (CE-LUS) of the liver during robot-assisted CRC surgery has not been studied, and this despite the fact that it seems technically possible to perform. With this project we will investigate whether CE-LUS associated with robotic surgery for CRC is technically feasible and whether it will be able to detect synchronous liver metastases that have not been detected on the preoperative imaging modalities.

Conditions

Colorectal Cancer

Keywords

contrast enhanced laparoscopic ultrasound; CE-LUS; LUS; robot assisted CRC resection

Outcome Measures

Primary Outcomes (1)

• Detection of synchronous liver metastases with CE-LUS

  3 months

Secondary Outcomes (1)

• CE-LUS feasibility

  15 minuts

Study Arms (1)

CE-LUS

EXPERIMENTAL

Laparoscopic ultrasound examination (LUS) of the liver during robot assisted CRC surgery. The liver is systematically scanned for unrecognized liver metastases. After the laparoscopic LUS procedure, the liver is then systematically scanned with contrast enhancement with SonoVue® containing Sulphurhexafluoride. A bolus of 2.5 ml is injected into a peripheral vein followed by 10 ml of isotonic saline. The liver is then systematically scanned in 3 phases (arterial, venous and parenchymatous phase) searching for unrecognized liver metastases. The procedure is repeated after 5 minutes. The time it takes to do the scan is measured and any technical challenges are reported. Time, challenges and findings of liver metastases (number, segment and size) are entered on a registration form.

Procedure: CE-LUS

Interventions

CE-LUS PROCEDURE

To assess the use of contrast enhanced LUS during robot assisted primary CRC surgery. Does CE-LUS detect any unrecognized liver metastases. The patient will get a contrast-enhanced CT scan 3 month after surgery as a control to the CE-LUS procedure.

Also known as: Sonovue

CE-LUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled to robot-assisted CRC resection
• patients with histologically verified cancer i colon or rectum
• informed consent
• patients with minimum age of 18
• patients without liver metastases

You may not qualify if:

• patients who have not given informed consent
• patients with severe heart disease, lung hypertension, or had had a heart attack \< 7 days
• patients with alcohol or drug abuse.
• patients with liver metastases

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Signe B Ellebaek, MD

  Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 29, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 26, 2016

Record last verified: 2015-01

Locations

DK (1)