Onderzoek naar het met een fluorescerende stof zichtbaar maken van de galwegen tijdens de operatie voor het verwijderen van de galblaas.

Pilot serie for visualisation of the common bile duct with indocyanine green during laparoscopic cholecystectomie with a near-infrared camera.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28880

Enrollment

Registered

2012-09-04

Start date

2011-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keywords: - laparoscopy - cholecystectomy - bile duct injury - common bile duct - cystic duct - fluorescence - near infrared - Indocyanine Green - critical view of safety - peroperative diagnostics

Interventions

Pre-operative patients receive 1 dosis of Indocyanine Green (ICG), a fluorescent contrast agent that is secreted in bile. Per-operative a near-infrared laparoscopic camera is used to visualize ICG in

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of symptomatic cholecystolithiasis with consistent physical examination, blood work and ultrasound.

Exclusion criteria

Exclusion criteria: 1. Use of listed medication: anti-epileptics, cyclopropane, bisulphite connexions, haloperidole, diamorphine, pethidine, morphine, nitrophurantoine, opium alkaloids, phenobarbital, phenylbutzaon, probenicid, metamizol, methadone, riphamycine or natriumbisulphite; 2. Allergy to ICG or Iodine; 3. Hyperthyroidsm.

Design outcomes

Primary

Measure	Time frame
1. Time of identification of the common bile duct and cystic duct; 2. Frequency of identification of the common bile duct and cystic duct.	—

Secondary

Measure	Time frame
1. Detection of biliary and arterial anatomic variations; 2. Prevention and detection of bile duct injuries.	—

Contacts

Public ContactD.A. Dam, van

De Boelelaan 1117 ZH 7F 002/004

d.vandam@vumc.nl+31 (0)20 4443601

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)