Acute CholecystitisNCT06573021
Fluorescent Cholangiography in Acute Cholecystitis
An observational study of Acute Cholecystitis, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Currently, there is limited scientific evidence regarding the effectiveness of fluorescent cholangiography in emergency cholecystectomy for acute cholecystitis. The primary aim of this study was to assess the efficacy of near-infrared fluorescent cholangiography to detect extrahepatic biliary anatomy in different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Near-infrared fluorescent cholangiography
- Type of treatment
- Injection or infusion
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 31 May 2024
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All patients aged >18 years-old with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised Tokyo guidelines 2018 who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms and patients fit for surgery with ASA score of 0-3.
Who may be able to join
- patients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised TG18 who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms;
- patients with ASA score of 1-3;
Who cannot join
- patients with a known allergy to indocyanine green;
- ASA score 4-5;
- patients deemed non-operable via laparoscopic approach due to high cardio-respiratory risk;
- previous surgical interventions on the biliary tract;
- history of liver cirrhosis or severe liver disease;
- ongoing pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unità Operativa Qualità, Accreditamento, Ricerca organizzativa
Ferrara, 44123
About this study
Official title: The Role of Fluorescent Cholangiography to Improve Operative Safety in Different Severity Degree of Acute Cholecystitis During Emergency Laparoscopic Cholecystectomy.
Currently, there is limited scientific evidence regarding the effectiveness of fluorescent cholangiography in emergency cholecystectomy for acute cholecystitis. The primary aim of this study was to assess the efficacy of near-infrared fluorescent cholangiography to detect extrahepatic biliary anatomy in different severity degrees of acute cholecystitis.
Read the detailed description
The study aims to to evaluate the efficacy of near-infrared fluorescent cholangiography for real-time visualization of the extrahepatic biliary tree (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct and any accessory or aberrant ducts) in emergency laparoscopic cholecystectomy before and after hepatocystic triangle dissection and in different degrees of severity of acute cholecystitis according to the American Association of Surgery for Trauma (AAST) classification, specifically distinguishing between non-gangrenous (grade I) and gangrenous or complicated (grades II-V) forms. For intra-operative fluorescent cholangiography, 2.5 mg indocyanine green (ICG) was administered intravenously 45-60 min prior to surgery, according to the recent guidelines from the International Society for Fluorescence Guided Surgery. All the operations were performed by the same team of surgeons. Near-infrared fluorescent cholangiography was performed by using Stryker's fluorescence imaging system (Stryker, Portage, Miami, USA). Near-infrared fluorescent cholangiography was performed at three defined time point during laparoscopic cholecystectomy: (i) following exposure of Calot's triangle, prior to any dissection; (ii) after partial dissection of Calot's triangle; (iii) after complete dissection of Calot's triangle, according to the "Critical View of Safety" method.
- Conditions
- Acute Cholecystitis
- Being tested
- Near-infrared fluorescent cholangiography
- Keywords
- acute cholecystitis, emergency laparoscopic cholecystectomy, near-infrared fluorescent cholangiography, AAST classification
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared fluorescent cholangiographyDrug
For intra-operative fluorescent cholangiography, 2.5 mg indocyanine green (ICG, Pulsion Medical Inc., Irving, Tx) was administered intravenously 45-60 min prior to surgery, according to the recent guidelines from the International Society for Fluorescence Guided Surgery (ISFGS) and the latest consensus conference published in 2021.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a clinical and radiological diagnosis of acute cholecystitis | Patients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised Tokyo guidelines who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms and patients with American Society of Anesthesiologists (ASA) score of 0-3. Near-infrared fluorescent cholangiography was performed at three time points during laparoscopic cholecystectomy: (i) following exposure of Calot's triangle, prior to any dissection; (ii) after partial dissection of Calot's triangle; (iii) after complete dissection of Calot's triangle. Receives: Drug: Near-infrared fluorescent cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy
The primary aim was to analyze the correct visualization by fluorescence of extrahepatic bile ducts (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct, and any accessory or aberrant ducts) before and after Calot's dissection in different grades of severity of acute cholecystitis according to the AAST classification, particularly distinguishing non-gangrenous forms (grade I) from gangrenous and complicated forms (grades II-V).
Measured: From start of surgery to the end of Calot's triangle dissection
Secondary outcomes (6)
Conversion rate in emergency cholecystectomy by fluorescence
Conversion rate (from laparoscopy to open approach)
Measured: perioperatively
The bail-out procedures rate in emergency cholecystectomy by fluorescence
Bail-out procedures during surgery, such as subtotal cholecystectomy, antegrade cholecystectomy
Measured: perioperatively
The rate of bile duct injuries in emergency cholecystectomy by fluorescence
Iatrogenic bile duct injuries
Measured: perioperatively
The duration of surgery in emergency cholecystectomy by fluorescence
Total surgery duration (minutes)
Measured: perioperatively
Analysis of post-operative complications in emergency cholecystectomy by fluorescence
Postoperative complications according to Clavien-Dindo classification
Measured: up to 30 days
The length of stay in emergency cholecystectomy by fluorescence
Length of hospital stay
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Jan 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Feo, University Hospital of Ferrara
- Investigators
- ANTONIO AP PESCE, MD PhD FACS, Study director, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573021
- Sponsor's protocol ID
- 1032/2021/Oss/AUSLFe
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
She WH, Cheung TT, Chan MY, Chu KW, Ma KW, Tsang SHY, Dai WC, Chan ACY, Lo CM. Routine use of ICG to enhance operative safety in emergency laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2022 Jun;36(6):4442-4451. doi: 10.1007/s00464-021-08795-2. Epub 2022 Feb 22.
PubMed 35194663Wang X, Teh CSC, Ishizawa T, Aoki T, Cavallucci D, Lee SY, Panganiban KM, Perini MV, Shah SR, Wang H, Xu Y, Suh KS, Kokudo N. Consensus Guidelines for the Use of Fluorescence Imaging in Hepatobiliary Surgery. Ann Surg. 2021 Jul 1;274(1):97-106. doi: 10.1097/SLA.0000000000004718.
PubMed 33351457Hernandez M, Murphy B, Aho JM, Haddad NN, Saleem H, Zeb M, Morris DS, Jenkins DH, Zielinski M. Validation of the AAST EGS acute cholecystitis grade and comparison with the Tokyo guidelines. Surgery. 2018 Apr;163(4):739-746. doi: 10.1016/j.surg.2017.10.041. Epub 2018 Jan 8.
PubMed 29325783Pesce A, La Greca G, Esposto Ultimo L, Basile A, Puleo S, Palmucci S. Effectiveness of near-infrared fluorescent cholangiography in the identification of cystic duct-common hepatic duct anatomy in comparison to magnetic resonance cholangio-pancreatography: a preliminary study. Surg Endosc. 2020 Jun;34(6):2715-2721. doi: 10.1007/s00464-019-07158-2. Epub 2019 Oct 9.
PubMed 31598878Pesce 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 34629815Pesce A, Palmucci S, La Greca G, Puleo S. Iatrogenic bile duct injury: impact and management challenges. Clin Exp Gastroenterol. 2019 Mar 6;12:121-128. doi: 10.2147/CEG.S169492. eCollection 2019.
PubMed 30881079Pesce A, Fabbri N, Bonazza L, Feo C. The role of fluorescent cholangiography to improve operative safety in different severity degrees of acute cholecystitis during emergency laparoscopic cholecystectomy: a prospective cohort study. Int J Surg. 2024 Dec 1;110(12):7775-7781. doi: 10.1097/JS9.0000000000002160.
PubMed 39806739
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Fluorescent Cholangiography to Improve Operative Safety in Different Severity Degree of Acute Cholecystitis During Emergency Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT06573021
- Acronym / sponsor ID
- 1032/2021/Oss/AUSLFe
- Conditions
- Acute Cholecystitis
- Keywords
- acute cholecystitis, emergency laparoscopic cholecystectomy, near-infrared fluorescent cholangiography, AAST classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, there is limited scientific evidence regarding the effectiveness of fluorescent cholangiography in emergency cholecystectomy for acute cholecystitis. The primary aim of this study was to assess the efficacy of near-infrared fluorescent cholangiography to detect extrahepatic biliary anatomy in different severity degrees of acute cholecystitis.
Detailed description
The study aims to to evaluate the efficacy of near-infrared fluorescent cholangiography for real-time visualization of the extrahepatic biliary tree (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct and any accessory or aberrant ducts) in emergency laparoscopic cholecystectomy before and after hepatocystic triangle dissection and in different degrees of severity of acute cholecystitis according to the American Association of Surgery for Trauma (AAST) classification, specifically distinguishing between non-gangrenous (grade I) and gangrenous or complicated (grades II-V) forms. For intra-operative fluorescent cholangiography, 2.5 mg indocyanine green (ICG) was administered intravenously 45-60 min prior to surgery, according to the recent guidelines from the International Society for Fluorescence Guided Surgery. All the operations were performed by the same team of surgeons. Near-infrared fluorescent cholangiography was performed by using Stryker's fluorescence imaging system (Stryker, Portage, Miami, USA). Near-infrared fluorescent cholangiography was performed at three defined time point during laparoscopic cholecystectomy: (i) following exposure of Calot's triangle, prior to any dissection; (ii) after partial dissection of Calot's triangle; (iii) after complete dissection of Calot's triangle, according to the "Critical View of Safety" method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a clinical and radiological diagnosis of acute cholecystitis | – | Drug: Near-infrared fluorescent cholangiographyPatients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised Tokyo guidelines who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms and patients with American Society of Anesthesiologists (ASA) score of 0-3. Near-infrared fluorescent cholangiography was performed at three time points during laparoscopic cholecystectomy: (i) following exposure of Calot's triangle, prior to any dissection; (ii) after partial dissection of Calot's triangle; (iii) after complete dissection of Calot's triangle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged >18 years-old with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised Tokyo guidelines 2018 who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms and patients fit for surgery with ASA score of 0-3.
Key inclusion criteria (2 listed)
- patients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised TG18 who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms;
- patients with ASA score of 1-3;
Key exclusion criteria (6 listed)
- patients with a known allergy to indocyanine green;
- ASA score 4-5;
- patients deemed non-operable via laparoscopic approach due to high cardio-respiratory risk;
- previous surgical interventions on the biliary tract;
- history of liver cirrhosis or severe liver disease;
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 |
|---|---|---|
| Near-infrared fluorescent cholangiographyFor intra-operative fluorescent cholangiography, 2.5 mg indocyanine green (ICG, Pulsion Medical Inc., Irving, Tx) was administered intravenously 45-60 min prior to surgery, according to the recent guidelines from the International Society for Fluorescence Guided Surgery (ISFGS) and the latest consensus conference published in 2021. | Drug | Patients with a clinical and radiological diagnosis of acute cholecystitis |
Primary outcome
Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy
Time frame: From start of surgery to the end of Calot's triangle dissection
The primary aim was to analyze the correct visualization by fluorescence of extrahepatic bile ducts (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct, and any accessory or aberrant ducts) before and after Calot's dissection in different grades of severity of acute cholecystitis according to the AAST classification, particularly distinguishing non-gangrenous forms (grade I) from gangrenous and complicated forms (grades II-V).
6 secondary outcomes
Conversion rate in emergency cholecystectomy by fluorescence
Time frame: perioperatively
The bail-out procedures rate in emergency cholecystectomy by fluorescence
Time frame: perioperatively
The rate of bile duct injuries in emergency cholecystectomy by fluorescence
Time frame: perioperatively
The duration of surgery in emergency cholecystectomy by fluorescence
Time frame: perioperatively
Analysis of post-operative complications in emergency cholecystectomy by fluorescence
Time frame: up to 30 days
The length of stay in emergency cholecystectomy by fluorescence
Time frame: perioperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 35194663She WH, Cheung TT, Chan MY, Chu KW, Ma KW, Tsang SHY, Dai WC, Chan ACY, Lo CM. Routine use of ICG to enhance operative safety in emergency laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2022 Jun;36(6):4442-4451. doi: 10.1007/s00464-021-08795-2. Epub 2022 Feb 22.
- Background: PubMed 33351457Wang X, Teh CSC, Ishizawa T, Aoki T, Cavallucci D, Lee SY, Panganiban KM, Perini MV, Shah SR, Wang H, Xu Y, Suh KS, Kokudo N. Consensus Guidelines for the Use of Fluorescence Imaging in Hepatobiliary Surgery. Ann Surg. 2021 Jul 1;274(1):97-106. doi: 10.1097/SLA.0000000000004718.
- Background: PubMed 29325783Hernandez M, Murphy B, Aho JM, Haddad NN, Saleem H, Zeb M, Morris DS, Jenkins DH, Zielinski M. Validation of the AAST EGS acute cholecystitis grade and comparison with the Tokyo guidelines. Surgery. 2018 Apr;163(4):739-746. doi: 10.1016/j.surg.2017.10.041. Epub 2018 Jan 8.
- Background: PubMed 31598878Pesce A, La Greca G, Esposto Ultimo L, Basile A, Puleo S, Palmucci S. Effectiveness of near-infrared fluorescent cholangiography in the identification of cystic duct-common hepatic duct anatomy in comparison to magnetic resonance cholangio-pancreatography: a preliminary study. Surg Endosc. 2020 Jun;34(6):2715-2721. doi: 10.1007/s00464-019-07158-2. Epub 2019 Oct 9.
- 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 30881079Pesce A, Palmucci S, La Greca G, Puleo S. Iatrogenic bile duct injury: impact and management challenges. Clin Exp Gastroenterol. 2019 Mar 6;12:121-128. doi: 10.2147/CEG.S169492. eCollection 2019.
- Derived from this study: PubMed 39806739Pesce A, Fabbri N, Bonazza L, Feo C. The role of fluorescent cholangiography to improve operative safety in different severity degrees of acute cholecystitis during emergency laparoscopic cholecystectomy: a prospective cohort study. Int J Surg. 2024 Dec 1;110(12):7775-7781. doi: 10.1097/JS9.0000000000002160.
- Individual participant dataSharing planned: No
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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.
ANTONIO AP PESCE, MD PhD FACS study director
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis, run by University Hospital of Ferrara at 1 site in Italy.
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 2 inclusion and 6 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy (time frame: From start of surgery to the end of Calot's triangle dissection). 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 NCT06573021, which also lists 7 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 27 Aug 2024.