Gastrointestinal and Gynecologic MalignanciesPhase 1NCT01944930
Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
A Phase 1 study testing Laparoscopic narrow band imaging and Standard white-light laparoscopy in people with Gastrointestinal and Gynecologic Malignancies, run by Lahey Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal and Gynecologic Malignancies
- What is being tested?
- Laparoscopic narrow band imaging and Standard white-light laparoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract
Who cannot join
- clinical contraindication to diagnostic laparoscopy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Laparoscopic narrow band imaging, Standard white-light laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic narrow band imagingDevice
Also called Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope
Standard white-light laparoscopyDevice
Also called Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laparoscopic narrow band imaging; Device: 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. Receives: Device: Laparoscopic narrow band imaging; Device: Standard white-light laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Detectable Peritoneal Metastases
number of additionally visualized peritoneal lesions
Measured: After each Laparoscopy, at time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal and Gynecologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Desmond H. Birkett, Lahey Clinic
- Investigators
- Thomas Schnelldorfer, MD, Study director, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944930
- Sponsor's protocol ID
- 2012-077
- Status last verified
- Dec 2020
- First submitted
- 13 May 2013
- Last updated
- 8 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 26194251
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
- ClinicalTrials.gov ID
- NCT01944930
- Acronym / sponsor ID
- 2012-077
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow Band Imaging Laparoscopy First | Experimental | Device: Laparoscopic narrow band imaging, Device: Standard white-light laparoscopyStudy 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 | Device: Laparoscopic narrow band imaging, Device: Standard white-light laparoscopyStudy has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients
- diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract
Key exclusion criteria (1 listed)
- clinical contraindication to diagnostic laparoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic narrow band imagingAlso: Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope | Device | Narrow Band Imaging Laparoscopy First, Standard White-Light Laparoscopy First |
| Standard white-light laparoscopyAlso: Olympus Evis Exera II CV-180 video processor; Olympus Evis Exera II CLV-180 light source; Olympus EndoEYE surgical videoscope | Device | Narrow Band Imaging Laparoscopy First, Standard White-Light Laparoscopy First |
Primary outcome
Rate of Detectable Peritoneal Metastases
Time frame: After each Laparoscopy, at time of procedure
number of additionally visualized peritoneal lesions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26194251Schnelldorfer 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Schnelldorfer, MD study director
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laparoscopic narrow band imaging and Standard white-light laparoscopy in people with Gastrointestinal and Gynecologic Malignancies, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Detectable Peritoneal Metastases (time frame: After each Laparoscopy, at time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.