Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

Lahey Health

Status and phase: Completed; Phase 1

Conditions: Gastrointestinal and Gynecologic Malignancies

Treatments: Device: Laparoscopic narrow band imaging; Device: Standard white-light laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01944930

2012-077

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• clinical contraindication to diagnostic laparoscopy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Narrow Band Imaging Laparoscopy First

Experimental group

Description:

Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.

Treatment:

Device: Standard white-light laparoscopy

Device: Laparoscopic narrow band imaging

Standard White-Light Laparoscopy First

Experimental group

Description:

Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy.

Treatment:

Device: Standard white-light laparoscopy

Device: Laparoscopic narrow band imaging