Trial Outcomes & Findings for The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy (NCT NCT01424215)

NCT ID: NCT01424215

Last Updated: 2020-05-12

Results Overview

The primary endpoint will be operative time measured as the minutes from the beginning of the dissection until the gallbladder is separated entirely from the gall bladder fossa. Minutes from start of procedure until recognition of structures.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: participants will be followed for the duration of hospital stay, an expected average of 48hours
• Results posted on: 2020-05-12

Participant Flow

Participant milestones

Measure	ICG Injection With Spyscope Imaging Indocyanine Green (ICG) Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)	Standard Critical View Technique 50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy

Baseline characteristics by cohort

Measure	ICG Injection With Spyscope Imaging n=50 Participants Indocyanine Green (ICG) Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)	Standard Critical View Technique n=50 Participants 50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.	Total n=100 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	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	46 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	4 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 48hours

The primary endpoint will be operative time measured as the minutes from the beginning of the dissection until the gallbladder is separated entirely from the gall bladder fossa. Minutes from start of procedure until recognition of structures.

Outcome measures

Measure	ICG Injection With Spyscope Imaging n=50 Participants Indocyanine Green (ICG) Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)	Standard Critical View Technique n=50 Participants 50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.
Operative Time	51.6 minutes Standard Deviation 11.06	44.4 minutes Standard Deviation 8.48

SECONDARY outcome

Timeframe: 0- 14 days Postoeprative

Minutes Surgeon is able to identify structures.

Outcome measures

Measure	ICG Injection With Spyscope Imaging n=50 Participants Indocyanine Green (ICG) Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)	Standard Critical View Technique n=50 Participants 50 patients will be randomized to the no treatment arm. These patients will not get ICG injection but rather will have the standard technique for laparoscopic cholecystectomy performed including the critical view technique to expose the important structures prior to clipping and division.
Identification of Structures	17.1 minutes Standard Deviation 6.05	20.2 minutes Standard Deviation 7.52

Adverse Events

ICG Injection With Spyscope Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Critical View Technique

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

Danny Sherwinter

Maimonides

Phone: 7182837952

Email: dsherwinter@maimonidesmed.org

Results disclosure agreements

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