Clinical trial · Interventional
Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal and Gynecologic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic narrow band imaging | Device | — | UNRESOLVED |
| Standard white-light laparoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Narrow Band Imaging Laparoscopy First
- description
- Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.
- interventionNames
- Device: Laparoscopic narrow band imaging
- Device: Standard white-light laparoscopy
- type
- EXPERIMENTAL
- label
- Standard White-Light Laparoscopy First
- description
- Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy.
- interventionNames
- Device: Laparoscopic narrow band imaging
- Device: Standard white-light laparoscopy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients * diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract Exclusion Criteria: * clinical contraindication to diagnostic laparoscopy
References
Publications (1)
- DERIVEDSchnelldorfer T, Jenkins RL, Birkett DH, Wright VJ, Price LL, Georgakoudi I. Laparoscopic narrow band imaging for detection of occult cancer metastases: a randomized feasibility trial. Surg Endosc. 2016 Apr;30(4):1656-61. doi: 10.1007/s00464-015-4401-9. Epub 2015 Jul 21. PMID 26194251