Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

December 14, 2020 updated by: Desmond H. Birkett, Lahey Clinic
Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered participation in the study. The proposed study is a randomized, controlled feasibility trial with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI. The order of white-light and NBI laparoscopy will be randomized for each patient (crossover design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing abnormalities using best clinical practices. The number of detected peritoneal metastases will be compared between each diagnostic laparoscopy technique. To gauge the rate of potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients
  • diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract

Exclusion Criteria:

  • clinical contraindication to diagnostic laparoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narrow Band Imaging Laparoscopy First
Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.
Device: Laparoscopic narrow band imaging
Other Names:
  • Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope
Device: Standard white-light laparoscopy
Other Names:
  • Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope
Experimental: Standard White-Light Laparoscopy First
Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy.
Device: Laparoscopic narrow band imaging
Other Names:
  • Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope
Device: Standard white-light laparoscopy
Other Names:
  • Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Detectable Peritoneal Metastases
Time Frame: After each Laparoscopy, at time of procedure
number of additionally visualized peritoneal lesions
After each Laparoscopy, at time of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahey Clinic

Investigators

  • Study Director: Thomas Schnelldorfer, MD, Lahey Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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