Gastrointestinal and Gynecologic Malignancies
Conditions
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.
Interventions
DEVICELaparoscopic narrow band imaging
DEVICEStandard white-light laparoscopy
Sponsors
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients * diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract
Exclusion criteria
* clinical contraindication to diagnostic laparoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Detectable Peritoneal Metastases | After each Laparoscopy, at time of procedure | number of additionally visualized peritoneal lesions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Standard White-Light Laparoscopy First | Total | Narrow Band Imaging Laparoscopy First |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 13 | 63 years STANDARD_DEVIATION 13 | 70 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 11 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Rate of Detectable Peritoneal Metastases
number of additionally visualized peritoneal lesions
Time frame: After each Laparoscopy, at time of procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narrow Band Imaging Laparoscopy | Rate of Detectable Peritoneal Metastases | 0 percentage of lesions |
| Standard White-Light Laparoscopy | Rate of Detectable Peritoneal Metastases | 2 percentage of lesions |