Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01881399
Other study ID # 12-004
Secondary ID 2012-A01664-39
Status Completed
Phase N/A
First received June 17, 2013
Last updated March 12, 2018
Start date November 2013
Est. completion date June 2016

Study information

Verified date March 2018
Source IHU Strasbourg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.

Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:

1. ease of use

2. lack of invasiveness

3. absence of ionizing radiation to the patient and the operating staff

4. performed prior to any dissection (prior to "critical view of safety")

Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.

The study requires a 2-month patient participation.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Man or woman > 18 years old

- Symptomatic gallbladder lithiasis or gallbladder polyps

- Clinical, biological ou medical imaging history leading to suspicion of gallstones migration

- Absence of contra-indication to anesthesia and cholecystectomy procedure

- Ability to understand the study related information and to provide written informed consent

- Registered with the French social security regime

Non inclusion Criteria:

- Inability to give informed consent

- Acute Cholecystitis

- Contraindications to MRI exam (claustrophobia, implantable devices)

- Potential risk of allergic reactions to iodine-containing contrast agents, to indocyanine green or other fluorescent compounds

- Pregnancy or breast-feeding

- Exclusion period from other clinical trial

- Forfeit freedom from an administrative or legal obligation

- Under guardianship

Study Design


Intervention

Device:
Fluorescence cholangiography (da Vinci surgical system)
Patients will received IV injection of ICG intra-operatively, allowing surgeons to view bile ducts under fluorescence imaging using the da Vinci surgical system with fluorescence Imaging system.
Other:
Virtual cholangiography
Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.
Procedure:
Conventional IOC
Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.

Locations

Country Name City State
France Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (1)

Diana M, Soler L, Agnus V, D'Urso A, Vix M, Dallemagne B, Faucher V, Roy C, Mutter D, Marescaux J, Pessaux P. Prospective Evaluation of Precision Multimodal Gallbladder Surgery Navigation: Virtual Reality, Near-infrared Fluorescence, and X-ray-based Intra — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography Percentage of patients for whom fluorescence allows for cysticocholedochal junction with precision at least as good as intraoperative cholangiography (identification of anatomical details and information).
Independent aposteriori evaluation performed by a radiologist/surgeon team.
Intra-operatively
Secondary To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy Percentage of patients for whom fluorescence-based imaging allows correct identification of biliary tree anatomy (anatomical variant, cystic duct stones, bile duct stones, dilated ducts) Intra-operatively
Secondary To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction Percentage of patients for whom enhanced reality allows correct identification of biliary tree anatomy,especially the cysticocholedochal junction Intra-operatively
Secondary To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute) Intra-operatively
See also
  Status Clinical Trial Phase
Completed NCT00616616 - Single Incision Laparoscopy N/A
Completed NCT00530998 - Minimally Invasive Surgery: Using Natural Orfices
Recruiting NCT00416234 - Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis N/A
Recruiting NCT05975385 - Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy N/A
Recruiting NCT06038201 - Cholecystectomy vs EUS-guided GBD With Stone Removal N/A
Not yet recruiting NCT03981315 - Bile Composition in Healthy and Gallstones Patients
Completed NCT01824186 - Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy N/A
Completed NCT00606762 - Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy N/A
Completed NCT00971750 - Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients N/A
Active, not recruiting NCT04279223 - Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia? N/A
Terminated NCT01708109 - Optimal Handling of Common Bile Duct Calculus, a Prospective Study N/A
Withdrawn NCT01146184 - Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD) N/A
Terminated NCT00910325 - Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy Phase 1/Phase 2
Completed NCT04672902 - Treatment of Mirizzi Syndrome
Completed NCT03180229 - Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy Phase 4
Not yet recruiting NCT01339325 - Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE Phase 4
Completed NCT02375529 - A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy N/A
Terminated NCT00486655 - NOTES-Assisted Laparoscopic Cholecystectomy Surgery N/A
Completed NCT00131131 - Epidemiology of Gallbladder Sludge and Stones in Pregnancy N/A
Terminated NCT00042549 - Lithotripsy for the Treatment of Gallstones Phase 4