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OpenTrials
Completed

NCT Number: NCT01944930

Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • clinical contraindication to diagnostic laparoscopy

Treatment and study plan

Laparoscopic narrow band imaging

Device

Other names: Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope

Standard white-light laparoscopy

Device

Other names: Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope

Primary outcomes

  1. Rate of Detectable Peritoneal Metastases

    Time frame: After each Laparoscopy, at time of procedure

    number of additionally visualized peritoneal lesions

Sponsors and collaborators

Lead sponsor

Lahey Clinic

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 18, 2013
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.