Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

Phase 1

Completed

• Conditions: Gastrointestinal and Gynecologic Malignancies
• Interventions: Device: Laparoscopic narrow band imaging; Device: Standard white-light laparoscopy

• Registration Number: NCT01944930
• Lead Sponsor: Lahey Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-18
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2020-10-14
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-14
• Last Update Submitted: 2020-12-14
• Results First Posted: 2021-01-08
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

Exclusion Criteria

• clinical contraindication to diagnostic laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard White-Light Laparoscopy First	Laparoscopic narrow band imaging	Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy.
Standard White-Light Laparoscopy First	Standard white-light laparoscopy	Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy.
Narrow Band Imaging Laparoscopy First	Laparoscopic narrow band imaging	Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.
Narrow Band Imaging Laparoscopy First	Standard white-light laparoscopy	Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.

Primary Outcome Measures

Name	Time	Method
Rate of Detectable Peritoneal Metastases	After each Laparoscopy, at time of procedure	number of additionally visualized peritoneal lesions

Trial Locations

Locations (1)

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States