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

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ClinicalTrials.gov Identifier: NCT02079389
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
Svendborg Hospital
Sygehus Lillebaelt
Sydvestjysk Hospital
Information provided by (Responsible Party):
MD Signe Bremholm Rasmussen, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Colon Cancer Rectum Cancer Liver Metastases Device: Lap+Lus Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Value of Laparoscopic Ultrasound in Patients Undergoing Laparoscopic Resection for Cancer of the Colon or Rectum: A Prospective Randomized Trial
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Lap+Lus

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

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.

Other Names:
  • BK medicals
  • ultrasound solutions

No Intervention: laparoscopic examination (Lap)

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.




Primary Outcome Measures :
  1. A change in the stage of Tumor, lymph Node and metastases (TNM-stage) [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. A change in the postoperative treatment strategy [ Time Frame: 3 months ]
    Will the use of laparoscopic ultrasound (LUS) during laparoscopic resection for colon and rectum cancer make af change in the patients treatment strategy. While using LUS during laparoscopic resection for colon and rectum cancer the tumor, lymph nodes, retroperitoneum and the liver is scanned with ultrasound and a peroperative TNM staging are done. If there are any differences in the peroperative TNM stage compared to the preoperative TNM stage, will it then have a consequence for the patient. For example: It could be a biopsy from a potential metastasis or enlarged lymph node ect. Will the changes alter the primary treatment strategy for the patient.


Other Outcome Measures:
  1. Does the use of contrast enhanced ultrasound examination during surgery for colon and rectum cancer provides more findings of liver metastases? [ Time Frame: 10 minutes ]
    The patients who are undergoing laparoscopic colon and rectum cancer surgery at the surgical department Odense University Hospital will get a contrast enhanced laparoscopic ultrasound examination.The laparoscopic ultrasound examination (LUS) is done at first. Then it will be supplied with a contrast enhanced examination done by a specialist in liver surgery. The liver is the primary focus and there is only searched for liver metastases. The examination will take about 10 minutes. If there is found a liver metastasis or if any are suspected the specialist i liver surgery will make sure that the patient will get the right treatment for the metastasis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079389


Locations
Denmark
Esbjerg Hospital
Esbjerg, Denmark, 6700
Odense University Hospital
Odense, Denmark, 5000
Svendborg Hospital
Svendborg, Denmark, 5700
Lillebaelt Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Odense University Hospital
Svendborg Hospital
Sygehus Lillebaelt
Sydvestjysk Hospital
Investigators
Study Director: Signe bremholm Rasmussen, MD Odense University Hospital
Principal Investigator: Michael Bau Mortensen, professor Odense University Hospital
Principal Investigator: Claus Fristrup, ph.d Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MD Signe Bremholm Rasmussen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02079389     History of Changes
Other Study ID Numbers: 20110135
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2013

Keywords provided by MD Signe Bremholm Rasmussen, Odense University Hospital:
colon cancer
rectum cancer
laparoscopic ultrasound
LUS
Contrast enhanced ultrasound
CEUS
Peroperative TNM staging
screening for liver metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Colonic Neoplasms
Rectal Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases