Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

Study Overview
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Brief Summary
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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.

Conditions
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Gastrointestinal and Gynecologic Malignancies

Intervention / Treatment
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* Device: Laparoscopic narrow band imaging
* Device: Standard white-light laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract Exclusion Criteria: clinical contraindication to diagnostic laparoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narrow Band Imaging Laparoscopy First<br>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<br> <br> * 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<br> <br> * 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<br>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<br> <br> * 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<br> <br> * 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?
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Primary Outcome Measures

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