The Value of Laparoscopic Ultrasound in Patients Undergoing Laparoscopic Resection for Cancer of the Colon or Rectum

NCT02079389 | Completed DMC

• 1 other identifier: 20110135
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 4

Brief Summary

The following project deals with a Danish multicenter trial that evaluates the value of Laparoscopic Ultrasound examination (LUS) in laparoscopic surgery for colon and rectum cancer (CRC). The project "The value of laparoscopic ultrasound in patients undergoing laparoscopic resection for colon and rectum cancer. - A prospective randomized trial" is part of a ph.d- study at the University of Southern Denmark in collaboration with several surgical departments at hospitals in Southern Denmark. The primary purpose is to investigate whether the use of laparoscopic ultrasound examination (LUS) will change the stage of the tumor, lymph node and metastasis (TNM stage) and the surgical approach in patients undergoing laparoscopic surgery for colorectal cancer (CRC). As a secondary objective; an evaluation of the use of LUS will change the treatment strategy for the individual patient with CRC. As an other objective we wants to investigate whether the use of contrast enhanced ultrasound examination in connection with LUS procedure increases the number of detected liver metastases.

Conditions

Colon Cancer; Rectum Cancer; Liver Metastases

Keywords

colon cancer; rectum cancer; laparoscopic ultrasound; LUS; Contrast enhanced ultrasound; CEUS; Peroperative TNM staging; screening for liver metastases

Outcome Measures

Primary Outcomes (1)

• A change in the stage of Tumor, lymph Node and metastases (TNM-stage)

  When using laparoscopic ultrasound examination (LUS) during laparoscopic resection for colon and rectum cancer, it is possible to scan the tumor, lymph nodes around the tumor, retroperitoneum and the liver. Thereby it is possible to make a preoperative TNM staging. Will the use of LUS change the stage of Tumor lymph Node and Metastases (TNM stage) compared to the preoperative TNM evaluation. The procedure LUS takes approximately 5 to 10 minutes. Tree months after surgery the patients will get a CT scan of the liver to ensure that the LUS did not miss any metastasis.

  3 months

Secondary Outcomes (1)

• A change in the postoperative treatment strategy

  3 months

Other Outcomes (1)

• Does the use of contrast enhanced ultrasound examination during surgery for colon and rectum cancer provides more findings of liver metastases?

  10 minutes

Study Arms (2)

Lap+Lus

ACTIVE COMPARATOR

The included patients randomly assigned either to the department's standard laparoscopic (Lap) surgery or standard laparoscopic surgery (lap) plus a LUS examination. In the intervention arm the intra-abdominal conditions are also assessed by laparoscopy, but then supplemented with a LUS examination of the primary tumor, liver and retroperitoneum. All the included patients are getting a CT scan of the abdomen after 3 months.

Device: Lap+Lus

laparoscopic examination (Lap)

NO INTERVENTION

The included patients randomly assigned either to the department's standard laparoscopic (Lap) surgery or standard laparoscopic surgery (lap) plus a LUS examination. In the standard arm (Lap) the conditions at the abdomen is only assessed by laparoscopy immediately prior to the resection. All the included patients are getting a CT scan of the abdomen after 3 months.

Interventions

Lap+Lus DEVICE

In the standard arm (Lap) the conditions at the abdomen is only assessed by laparoscopy immediately prior to the resection. In the intervention arm the intra-abdominal conditions are also assessed by laparoscopy, but then supplemented with a laparoscopic ultrasound examination of the primary tumor, liver and retroperitoneum. All patients are given an CT scan of the abdomen after 3 months.

Also known as: BK medicals, ultrasound solutions

Lap+Lus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with colon and rectum cancer without known metastasis
• Patients who gives informed consent
• Patients who are referral to laparoscopic surgery

You may not qualify if:

• Patients who are not able to give informed consent
• Patients who are under 18 of age Patients with known metastasis.
• Patients who are allergic to contrast agents
• Patients who are pregnant or lactating

Sponsors & Collaborators

• Odense University Hospital: lead
• Svendborg Hospital: collaborator
• Sygehus Lillebaelt: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

Study Sites (4)

Esbjerg Hospital

Esbjerg, Esbjerg, 6700, Denmark

Location

Odense University Hospital

Odense, Odense, 5000, Denmark

Location

Svendborg Hospital

Svendborg, Svendborg, 5700, Denmark

Location

Lillebaelt Hospital

Vejle, Vejle, 7100, Denmark

Location

Related Publications (1)

• Ellebaek SB, Fristrup CW, Hovendal C, Qvist N, Bundgaard L, Salomon S, Stovring J, Mortensen MB. Randomized clinical trial of laparoscopic ultrasonography before laparoscopic colorectal cancer resection. Br J Surg. 2017 Oct;104(11):1462-1469. doi: 10.1002/bjs.10636.

  PMID: 28895143 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; 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 bremholm Rasmussen, MD

  Odense University Hospital

  STUDY DIRECTOR

• Michael Bau Mortensen, professor

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Claus Fristrup, ph.d

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: March 5, 2014
• Study Start: May 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2013-05

Locations

DK (4)