Laparoscopic CholecystectomyPhase 4DOTIGNCT05419947
Clinical Trial for the Optimization of Indocyanine Green Administration in NIRF-C During L.Cholecystectomy.
A Phase 4 study testing VERDYE powder for solution for injection 25 mg in people with Laparoscopic Cholecystectomy, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 2 sites in Spain.
Trial summary
Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- VERDYE powder for solution for injection 25 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Jun 2022to 24 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- Autonomy, self-sufficiency and independence.
- Scheduled CL indication:
- Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis.
- Gallbladder polyps with indication for laparoscopic surgery.
- Vesicular adenomyomatosis with indication for laparoscopic surgery.
Show all 10Show fewer
- Indication of early LC (<72 hours of admission for acute stone cholecystitis/acute acalculous cholecystitis/complicated biliary colic).
- Deferred urgency LC indication.
- Understanding of information.
- Signature of the informed consent.
Who cannot join
- Age less than 18 years.
- Disability.
- Pregnancy or lactation.
- Chronic kidney disease (Stage > IIIb).
- Previous adverse reactions or allergies to VI.
- Previous adverse reactions or allergies to VI excipients.
Show all 13Show fewer
- Adverse reactions or confirmed allergies to iodinated contrast agents.
- Functional thyroid pathology (hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma).
- Urgent non-deferrable/emergent gallbladder surgery.
- Initial surgery by laparotomy.
- Previous suspicion of gallbladder carcinoma.
- Inability to understand the information needed to participate in the study.
- Rejection of inclusion within the study protocol.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Germans Trias i Pujol.
Badalona, Barcelona, 08916
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
About this study
Official title: Randomized Clinical Trial for the Optimization of Indocyanine Green Administration in Near-infrared Fluorescent Cholangiography During Laparoscopic Cholecystectomy.
Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. There are different surgical strategies that try to reduce this complication, with indocyanine green fluorescence cholangiography being one of the most recent to appear. This technique is becoming a great tool during laparoscopic cholecystectomy. Despite the great rise of the procedure, today there is a great disparity in the administration protocols of indocyanine green during the procedure.
Goals. The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.
Read the detailed description
Symptomatic cholelithiasis is a pathology of great relevance in the world population, with prevalence rates of up to 20%. The standard treatment for cholelithiasis is laparoscopic cholecystectomy (LC). One of the most serious complications of LC is injury to the main bile duct (LVB). Although this complication has incidences of less than 1% (0.3-0.7% in the different series), the consequences it causes are highly relevant. LVB is related to a significant increase in patient morbidity and mortality, a significant deterioration in quality of life, a very significant increase in healthcare costs and not insignificant medical-legal consequences. Indocyanine green fluorescence cholangiography (CF-VI) is a novel technique that allows precise and real-time anatomical visualization of the extrahepatic biliary anatomy, facilitating surgery and reducing the risk of complications. Currently, there are large differences in LV administration protocols during CF in LC. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization. In relation to the dose, there are many protocols for IV administration, by means of a single dose or a dose adjusted for the patient's body weight. Some authors advocate the administration of IV 24 hours before the procedure, in order to avoid hepatic fluorescence. However, in the context of major outpatient surgery, outpatient surgery or short-stay surgery, we believe that this practice is not currently logistically feasible. Other groups administer the IV with a variable range of time interval. The recent preliminary results of the European Registry of Fluorescent Image Guided Surgery show the great disparity of preoperative LV administration protocols. Therefore, it is necessary to protocolize the administration of the drug based on the results of randomized clinical trials.. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- VERDYE powder for solution for injection 25 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERDYE powder for solution for injection 25 mgDrug
Also called Indocyanine green (ICG)
Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
| Study group | Role | What they receive |
|---|---|---|
| Fixed dose 3 hours | Experimental | Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery. Receives: Drug: VERDYE powder for solution for injection 25 mg |
| Fixed dose 30 min | Experimental | Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery). Receives: Drug: VERDYE powder for solution for injection 25 mg |
| Weight-adjusted dose 3 hour | Experimental | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. Receives: Drug: VERDYE powder for solution for injection 25 mg |
| Weight-adjusted dose 30 min | Experimental | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). Receives: Drug: VERDYE powder for solution for injection 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun.
Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Measured: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun.
Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Measured: During surgical procedure, after dissection of the hepatocystic triangle.
Secondary outcomes (4)
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun.
The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Measured: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun.
The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Measured: During surgical procedure, after the disection of the hepatocystic triangle has begun.
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery
Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun.
The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Measured: During surgical procedure
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun.
The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start20 Jun 2022
- Primary completion16 May 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects included in this CT will be treated with VI \[Verdye (Diagnostic Green GMBH, Aschheim-Dornach, Germany)\]. Single dose and weight-adjusted dose and different administration intervals will be analyzed. Low-intervention clinical trial.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Sponsor
- Investigators
- Jaime López Sánchez, MD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419947
- Sponsor's protocol ID
- IBS-DOTIG-ECM-2202
- Other IDs
- 2022-000904-36
- Acronym
- DOTIG
- Status last verified
- Jun 2025
- First submitted
- 27 May 2022
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Ansaloni L, Pisano M, Coccolini F, Peitzmann AB, Fingerhut A, Catena F, Agresta F, Allegri A, Bailey I, Balogh ZJ, Bendinelli C, Biffl W, Bonavina L, Borzellino G, Brunetti F, Burlew CC, Camapanelli G, Campanile FC, Ceresoli M, Chiara O, Civil I, Coimbra R, De Moya M, Di Saverio S, Fraga GP, Gupta S, Kashuk J, Kelly MD, Koka V, Jeekel H, Latifi R, Leppaniemi A, Maier RV, Marzi I, Moore F, Piazzalunga D, Sakakushev B, Sartelli M, Scalea T, Stahel PF, Taviloglu K, Tugnoli G, Uraneus S, Velmahos GC, Wani I, Weber DG, Viale P, Sugrue M, Ivatury R, Kluger Y, Gurusamy KS, Moore EE. 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg. 2016 Jun 14;11:25. doi: 10.1186/s13017-016-0082-5. eCollection 2016.
PubMed 27307785Tazuma S, Unno M, Igarashi Y, Inui K, Uchiyama K, Kai M, Tsuyuguchi T, Maguchi H, Mori T, Yamaguchi K, Ryozawa S, Nimura Y, Fujita N, Kubota K, Shoda J, Tabata M, Mine T, Sugano K, Watanabe M, Shimosegawa T. Evidence-based clinical practice guidelines for cholelithiasis 2016. J Gastroenterol. 2017 Mar;52(3):276-300. doi: 10.1007/s00535-016-1289-7. Epub 2016 Dec 10.
PubMed 27942871Pesce A, Piccolo G, Lecchi F, Fabbri N, Diana M, Feo CV. Fluorescent cholangiography: An up-to-date overview twelve years after the first clinical application. World J Gastroenterol. 2021 Sep 28;27(36):5989-6003. doi: 10.3748/wjg.v27.i36.5989.
PubMed 34629815Nuzzo G, Giuliante F, Giovannini I, Ardito F, D'Acapito F, Vellone M, Murazio M, Capelli G. Bile duct injury during laparoscopic cholecystectomy: results of an Italian national survey on 56 591 cholecystectomies. Arch Surg. 2005 Oct;140(10):986-92. doi: 10.1001/archsurg.140.10.986.
PubMed 16230550Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.
PubMed 8000648Gupta V, Jain G. Safe laparoscopic cholecystectomy: Adoption of universal culture of safety in cholecystectomy. World J Gastrointest Surg. 2019 Feb 27;11(2):62-84. doi: 10.4240/wjgs.v11.i2.62.
PubMed 30842813Mascagni P, Vardazaryan A, Alapatt D, Urade T, Emre T, Fiorillo C, Pessaux P, Mutter D, Marescaux J, Costamagna G, Dallemagne B, Padoy N. Artificial Intelligence for Surgical Safety: Automatic Assessment of the Critical View of Safety in Laparoscopic Cholecystectomy Using Deep Learning. Ann Surg. 2022 May 1;275(5):955-961. doi: 10.1097/SLA.0000000000004351. Epub 2020 Nov 16.
PubMed 33201104Flum DR, Dellinger EP, Cheadle A, Chan L, Koepsell T. Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy. JAMA. 2003 Apr 2;289(13):1639-44. doi: 10.1001/jama.289.13.1639.
PubMed 12672731Vlek SL, van Dam DA, Rubinstein SM, de Lange-de Klerk ESM, Schoonmade LJ, Tuynman JB, Meijerink WJHJ, Ankersmit M. Biliary tract visualization using near-infrared imaging with indocyanine green during laparoscopic cholecystectomy: results of a systematic review. Surg Endosc. 2017 Jul;31(7):2731-2742. doi: 10.1007/s00464-016-5318-7. Epub 2016 Nov 14.
PubMed 27844236Ishizawa T, Bandai Y, Ijichi M, Kaneko J, Hasegawa K, Kokudo N. Fluorescent cholangiography illuminating the biliary tree during laparoscopic cholecystectomy. Br J Surg. 2010 Sep;97(9):1369-77. doi: 10.1002/bjs.7125.
PubMed 20623766Reinhart MB, Huntington CR, Blair LJ, Heniford BT, Augenstein VA. Indocyanine Green: Historical Context, Current Applications, and Future Considerations. Surg Innov. 2016 Apr;23(2):166-75. doi: 10.1177/1553350615604053. Epub 2015 Sep 10.
PubMed 26359355Lim SH, Tan HTA, Shelat VG. Comparison of indocyanine green dye fluorescent cholangiography with intra-operative cholangiography in laparoscopic cholecystectomy: a meta-analysis. Surg Endosc. 2021 Apr;35(4):1511-1520. doi: 10.1007/s00464-020-08164-5. Epub 2021 Jan 4.
PubMed 33398590Dip F, LoMenzo E, Sarotto L, Phillips E, Todeschini H, Nahmod M, Alle L, Schneider S, Kaja L, Boni L, Ferraina P, Carus T, Kokudo N, Ishizawa T, Walsh M, Simpfendorfer C, Mayank R, White K, Rosenthal RJ. Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography. Ann Surg. 2019 Dec;270(6):992-999. doi: 10.1097/SLA.0000000000003178.
PubMed 30614881van den Bos J, Wieringa FP, Bouvy ND, Stassen LPS. Optimizing the image of fluorescence cholangiography using ICG: a systematic review and ex vivo experiments. Surg Endosc. 2018 Dec;32(12):4820-4832. doi: 10.1007/s00464-018-6233-x. Epub 2018 May 18.
PubMed 29777357Verbeek FP, Schaafsma BE, Tummers QR, van der Vorst JR, van der Made WJ, Baeten CI, Bonsing BA, Frangioni JV, van de Velde CJ, Vahrmeijer AL, Swijnenburg RJ. Optimization of near-infrared fluorescence cholangiography for open and laparoscopic surgery. Surg Endosc. 2014 Apr;28(4):1076-82. doi: 10.1007/s00464-013-3305-9.
PubMed 24232054
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for the Optimization of Indocyanine Green Administration in Near-infrared Fluorescent Cholangiography During Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT05419947
- Acronym / sponsor ID
- DOTIG / IBS-DOTIG-ECM-2202
- Conditions
- Laparoscopic Cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. There are different surgical strategies that try to reduce this complication, with indocyanine green fluorescence cholangiography being one of the most recent to appear. This technique is becoming a great tool during laparoscopic cholecystectomy. Despite the great rise of the procedure, today there is a great disparity in the administration protocols of indocyanine green during the procedure.
Goals. The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.
Detailed description
Symptomatic cholelithiasis is a pathology of great relevance in the world population, with prevalence rates of up to 20%. The standard treatment for cholelithiasis is laparoscopic cholecystectomy (LC). One of the most serious complications of LC is injury to the main bile duct (LVB). Although this complication has incidences of less than 1% (0.3-0.7% in the different series), the consequences it causes are highly relevant. LVB is related to a significant increase in patient morbidity and mortality, a significant deterioration in quality of life, a very significant increase in healthcare costs and not insignificant medical-legal consequences. Indocyanine green fluorescence cholangiography (CF-VI) is a novel technique that allows precise and real-time anatomical visualization of the extrahepatic biliary anatomy, facilitating surgery and reducing the risk of complications. Currently, there are large differences in LV administration protocols during CF in LC. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization. In relation to the dose, there are many protocols for IV administration, by means of a single dose or a dose adjusted for the patient's body weight. Some authors advocate the administration of IV 24 hours before the procedure, in order to avoid hepatic fluorescence. However, in the context of major outpatient surgery, outpatient surgery or short-stay surgery, we believe that this practice is not currently logistically feasible. Other groups administer the IV with a variable range of time interval. The recent preliminary results of the European Registry of Fluorescent Image Guided Surgery show the great disparity of preoperative LV administration protocols. Therefore, it is necessary to protocolize the administration of the drug based on the results of randomized clinical trials.. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects included in this CT will be treated with VI [Verdye (Diagnostic Green GMBH, Aschheim-Dornach, Germany)]. Single dose and weight-adjusted dose and different administration intervals will be analyzed. Low-intervention clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Fixed dose 3 hours | Experimental | Drug: VERDYE powder for solution for injection 25 mgFixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery. |
| Fixed dose 30 min | Experimental | Drug: VERDYE powder for solution for injection 25 mgFixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery). |
| Weight-adjusted dose 3 hour | Experimental | Drug: VERDYE powder for solution for injection 25 mgWeight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. |
| Weight-adjusted dose 30 min | Experimental | Drug: VERDYE powder for solution for injection 25 mgWeight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age over 18 years.
- Autonomy, self-sufficiency and independence.
- Scheduled CL indication:
- Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis.
- Gallbladder polyps with indication for laparoscopic surgery.
Key exclusion criteria (13 listed)
- Age less than 18 years.
- Disability.
- Pregnancy or lactation.
- Chronic kidney disease (Stage > IIIb).
- Previous adverse reactions or allergies to VI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VERDYE powder for solution for injection 25 mgAlso: Indocyanine green (ICG)Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. | Drug | Fixed dose 3 hours, Fixed dose 30 min, Weight-adjusted dose 3 hour, Weight-adjusted dose 30 min |
Primary outcome
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Time frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Time frame: During surgical procedure, after dissection of the hepatocystic triangle.
Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
4 secondary outcomes
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Time frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Time frame: During surgical procedure, after the disection of the hepatocystic triangle has begun.
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery
Time frame: During surgical procedure
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Time frame: During surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27307785Ansaloni L, Pisano M, Coccolini F, Peitzmann AB, Fingerhut A, Catena F, Agresta F, Allegri A, Bailey I, Balogh ZJ, Bendinelli C, Biffl W, Bonavina L, Borzellino G, Brunetti F, Burlew CC, Camapanelli G, Campanile FC, Ceresoli M, Chiara O, Civil I, Coimbra R, De Moya M, Di Saverio S, Fraga GP, Gupta S, Kashuk J, Kelly MD, Koka V, Jeekel H, Latifi R, Leppaniemi A, Maier RV, Marzi I, Moore F, Piazzalunga D, Sakakushev B, Sartelli M, Scalea T, Stahel PF, Taviloglu K, Tugnoli G, Uraneus S, Velmahos GC, Wani I, Weber DG, Viale P, Sugrue M, Ivatury R, Kluger Y, Gurusamy KS, Moore EE. 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg. 2016 Jun 14;11:25. doi: 10.1186/s13017-016-0082-5. eCollection 2016.
- Background: PubMed 27942871Tazuma S, Unno M, Igarashi Y, Inui K, Uchiyama K, Kai M, Tsuyuguchi T, Maguchi H, Mori T, Yamaguchi K, Ryozawa S, Nimura Y, Fujita N, Kubota K, Shoda J, Tabata M, Mine T, Sugano K, Watanabe M, Shimosegawa T. Evidence-based clinical practice guidelines for cholelithiasis 2016. J Gastroenterol. 2017 Mar;52(3):276-300. doi: 10.1007/s00535-016-1289-7. Epub 2016 Dec 10.
- Background: PubMed 34629815Pesce A, Piccolo G, Lecchi F, Fabbri N, Diana M, Feo CV. Fluorescent cholangiography: An up-to-date overview twelve years after the first clinical application. World J Gastroenterol. 2021 Sep 28;27(36):5989-6003. doi: 10.3748/wjg.v27.i36.5989.
- Background: PubMed 16230550Nuzzo G, Giuliante F, Giovannini I, Ardito F, D'Acapito F, Vellone M, Murazio M, Capelli G. Bile duct injury during laparoscopic cholecystectomy: results of an Italian national survey on 56 591 cholecystectomies. Arch Surg. 2005 Oct;140(10):986-92. doi: 10.1001/archsurg.140.10.986.
- Background: PubMed 8000648Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.
- Background: PubMed 30842813Gupta V, Jain G. Safe laparoscopic cholecystectomy: Adoption of universal culture of safety in cholecystectomy. World J Gastrointest Surg. 2019 Feb 27;11(2):62-84. doi: 10.4240/wjgs.v11.i2.62.
- Background: PubMed 33201104Mascagni P, Vardazaryan A, Alapatt D, Urade T, Emre T, Fiorillo C, Pessaux P, Mutter D, Marescaux J, Costamagna G, Dallemagne B, Padoy N. Artificial Intelligence for Surgical Safety: Automatic Assessment of the Critical View of Safety in Laparoscopic Cholecystectomy Using Deep Learning. Ann Surg. 2022 May 1;275(5):955-961. doi: 10.1097/SLA.0000000000004351. Epub 2020 Nov 16.
- Background: PubMed 12672731Flum DR, Dellinger EP, Cheadle A, Chan L, Koepsell T. Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy. JAMA. 2003 Apr 2;289(13):1639-44. doi: 10.1001/jama.289.13.1639.
- Background: PubMed 27844236Vlek SL, van Dam DA, Rubinstein SM, de Lange-de Klerk ESM, Schoonmade LJ, Tuynman JB, Meijerink WJHJ, Ankersmit M. Biliary tract visualization using near-infrared imaging with indocyanine green during laparoscopic cholecystectomy: results of a systematic review. Surg Endosc. 2017 Jul;31(7):2731-2742. doi: 10.1007/s00464-016-5318-7. Epub 2016 Nov 14.
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- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime López Sánchez, MD principal investigator
University of Salamanca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VERDYE powder for solution for injection 25 mg in people with Laparoscopic Cholecystectomy, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. (time frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05419947, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.