CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Laparoscopic narrow band imaging +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01944930
NCT01944930Phase 1Completed

Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

Lahey Clinic·interventional·Posted Sep 18, 2013·Updated Jan 8, 2021

In Brief

A Phase 1 clinical trial evaluating Laparoscopic narrow band imaging and Standard white-light laparoscopy for Gastrointestinal and Gynecologic Malignancies. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2013
Enrollment StartJan 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.8 years ago

Interventions

Laparoscopic narrow band imagingdevice

Standard white-light laparoscopydevice