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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrow Band Imaging Laparoscopy First | Experimental | Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy. |
|
| Standard White-Light Laparoscopy First | Experimental | Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic narrow band imaging | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Detectable Peritoneal Metastases | number of additionally visualized peritoneal lesions | After each Laparoscopy, at time of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Schnelldorfer, MD | Lahey Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26194251 | Derived | Schnelldorfer 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Narrow Band Imaging Laparoscopy First | Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy. Laparoscopic narrow band imaging Standard white-light laparoscopy |
| FG001 | Standard White-Light Laparoscopy First | Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy. Laparoscopic narrow band imaging Standard white-light laparoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Narrow Band Imaging Laparoscopy First | Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy. Laparoscopic narrow band imaging Standard white-light laparoscopy |
| BG001 | Standard White-Light Laparoscopy First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Detectable Peritoneal Metastases | number of additionally visualized peritoneal lesions | Posted | Number | percentage of lesions | After each Laparoscopy, at time of procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Narrow Band Imaging Laparoscopy First | Study has single cohort assessed in crossover design. In this arm NBI laparoscopy will be performed first, followed by standard white-light laparoscopy. Therefore any adverse event cannot be traced back to each single intervention and can only be described cumulative. Laparoscopic narrow band imaging Standard white-light laparoscopy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Schnelldorfer | Lahey Hospital and Medical Center | 781-744-5100 | thomas.schnelldorfer@lahey.org |
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| Standard white-light laparoscopy | Device |
|
|
Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy. Laparoscopic narrow band imaging Standard white-light laparoscopy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Standard White-Light Laparoscopy First | Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy. Therefore any adverse event cannot be traced back to each single intervention and can only be described cumulative. Laparoscopic narrow band imaging Standard white-light laparoscopy | 0 | 10 | 0 | 10 | 0 | 10 |
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