Phase 1
N=23
Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
Gastrointestinal and Gynecologic Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT01944930 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Rate of Detectable Peritoneal Metastases — 0; 2 percentage of lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Laparoscopic narrow band imaging (Device); Standard white-light laparoscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lahey Clinic
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Detectable Peritoneal Metastases |
0; 2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- adult patients
- diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract
Exclusion Criteria
- clinical contraindication to diagnostic laparoscopy
Data sourced from ClinicalTrials.gov (NCT01944930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.