Onderzoek naar het met een fluorescerende stof zichtbaar maken van de galwegen tijdens operatie voor het verwijderen van de galblaas in patiënten met gecompliceerd galsteenlijden

Prospective, non-randomized trial of fluorescent near-infrared imaging with indocyanine green during laparoscopic cholecystectomy in patients at increased risk of bile duct injury.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24068

Enrollment

Registered

2014-07-10

Start date

2012-12-01

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

Laparoscopy, Cholecystectomy, Bile ducts, Bile duct injury, Infrared, Complicated gallbladder disease

Interventions

Pre-operative patients receive 1 dosis of Indocyanine Green (ICG), which is a fluorescent contrast agent that is excreted by the liver into the bile. Per-operative a near-infrared laparoscopic camera

Eligibility

Inclusion criteria

Inclusion criteria: acute cholecystitis, biliary pancreatitis, choledocholithiasis or cholecystolithiasis resulting in hospital admission, endoscopic retrograde pancreatic-cholangiography (ERCP) or percutaneous gallbladder drainage.

Exclusion criteria

Exclusion criteria: 1. anti-convulsive medication, cyclopropane, bisulphite connexions, haloperidole, diamorphine, pethidine, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazon, probenicid, metamizole, rifamycine, methadone, sodium bisulphite 2. Allergy to ICG or Iodine 3. Hypothyreoidism, Hyperthyreoidism.

Design outcomes

Primary

Measure	Time frame
1. Time of identification of the common bile duct and the cystic duct 2. Frequency of identification of the common bile duct and cystic duct 3. Feasibility of ICG in complicated gallbladder disease	—

Secondary

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

Contacts

Public ContactM. Ankersmit

m.ankersmit1@vumc.nl0031204445234

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)