Trial Outcomes & Findings for Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases (NCT NCT01944930)

NCT ID: NCT01944930

Last Updated: 2021-01-08

Results Overview

number of additionally visualized peritoneal lesions

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 23 participants
• Primary outcome timeframe: After each Laparoscopy, at time of procedure
• Results posted on: 2021-01-08

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	12	11
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

Baseline characteristics by cohort

Measure	Narrow Band Imaging Laparoscopy First n=10 Participants 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	Standard White-Light Laparoscopy First n=10 Participants 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	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	70 years STANDARD_DEVIATION 9 • n=5 Participants	56 years STANDARD_DEVIATION 13 • n=7 Participants	63 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: After each Laparoscopy, at time of procedure

number of additionally visualized peritoneal lesions

Outcome measures

Measure	Narrow Band Imaging Laparoscopy n=20 Participants 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 n=20 Participants Study has single cohort assessed in crossover design. In this arm standard white-light laparoscopy will be performed first, followed by NBI laparoscopy. Standard white-light laparoscopy
Rate of Detectable Peritoneal Metastases	0 percentage of lesions	2 percentage of lesions

Adverse Events

Narrow Band Imaging Laparoscopy First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard White-Light Laparoscopy First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Schnelldorfer

Lahey Hospital and Medical Center

Phone: 781-744-5100

Email: thomas.schnelldorfer@lahey.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place