Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

Gastrointestinal and Gynecologic Malignancies Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944930
• Other study ID #: 2012-077
• Status: Completed
• Phase: Phase 1
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2020
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients

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

Exclusion Criteria:

• clinical contraindication to diagnostic laparoscopy

Related Conditions & MeSH terms

• Gastrointestinal and Gynecologic Malignancies
• Neoplasms

Intervention

Device:
• Laparoscopic narrow band imaging

• Standard white-light laparoscopy

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Detectable Peritoneal Metastases	number of additionally visualized peritoneal lesions	After each Laparoscopy, at time of procedure