A Phase 1 interventional study of Laparoscopic narrow band imaging and Standard white-light laparoscopy in Gastrointestinal and Gynecologic Malignancies, sponsored by Lahey Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Lahey Clinic · Phase 1, Interventional, and Diagnostic
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 23 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy.
Device: Laparoscopic narrow band imaging · Device: 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.
Device: Laparoscopic narrow band imaging · Device: Standard white-light laparoscopy
Also known as: Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope
Also known as: Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope
Rate of Detectable Peritoneal Metastases
number of additionally visualized peritoneal lesions
Time frame: After each Laparoscopy, at time of procedure
| Milestone | Narrow Band Imaging Laparoscopy First | Standard White-Light Laparoscopy First |
|---|---|---|
| Started | 12 | 11 |
| Completed | 10 | 10 |
| Not completed | 2 | 1 |
number of additionally visualized peritoneal lesions
| percentage of lesions | Narrow Band Imaging Laparoscopy | Standard White-Light Laparoscopy |
|---|---|---|
| Rate of Detectable Peritoneal Metastases | 0 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Narrow Band Imaging Laparoscopy First | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Standard White-Light Laparoscopy First | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Narrow Band Imaging Laparoscopy First | Standard White-Light Laparoscopy First | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Narrow Band Imaging Laparoscopy First | Standard White-Light Laparoscopy First | Total |
|---|---|---|---|
| Mean | 70 ± 9 | 56 ± 13 | 63 ± 13 |
| Sex: Female, Male(Participants) | Narrow Band Imaging Laparoscopy First | Standard White-Light Laparoscopy First | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 5 | 6 | 11 |
| Region of Enrollment(participants) | Narrow Band Imaging Laparoscopy First | Standard White-Light Laparoscopy First | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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