Acute CholecystitisNCT07551388
CBD Wall-Thickness Adjusted ICG Microdosing for Fluorescence Cholangiography in Moderate-to-Severe Acute Cholecystitis: A Single-Center Prospective Study
A study testing Indocyanine Green (ICG) Fluorescence Cholangiography in people with Acute Cholecystitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a single-center prospective study designed to develop and validate an individualized, low-dose indocyanine green (ICG) protocol for near-infrared fluorescence cholangiography during emergency laparoscopic cholecystectomy in patients with moderate to severe acute cholecystitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Indocyanine Green (ICG) Fluorescence Cholangiography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2025to 31 Oct 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years undergoing emergency laparoscopic cholecystectomy.
- Diagnosis of moderate to severe acute cholecystitis according to the 2018 Tokyo Guidelines.
- Preoperative MRI available for common bile duct wall thickness measurement.
- Ability to provide informed consent.
Who cannot join
- Known allergy or contraindication to indocyanine green (ICG).
- Severe renal or hepatic dysfunction (eGFR <30 mL/min/1.73m² or Child-Pugh class B/C cirrhosis).
- Pregnancy or breastfeeding.
- Previous biliary surgery or known choledocholithiasis requiring preoperative intervention.
- Unstable hemodynamic status requiring conversion to open surgery before ICG administration.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Optimal Weight-Based Indocyanine Green Dosage for Fluorescent Cholangiography in Laparoscopic Cholecystectomy Among Chinese Population：Construction and Validation
This is a single-center prospective study designed to develop and validate an individualized, low-dose indocyanine green (ICG) protocol for near-infrared fluorescence cholangiography during emergency laparoscopic cholecystectomy in patients with moderate to severe acute cholecystitis.
The main problem we aim to solve is that inflammation in the bile duct wall often makes standard ICG doses ineffective for clear visualization. We will use pre-operative MRI to measure the thickness of the common bile duct (CBD) wall, then calculate a personalized ICG dose using a simple formula. We will first test and refine this formula in a small group of patients, then verify its effectiveness in a second group. The goal is to achieve clear, high-contrast imaging of the bile ducts, which helps surgeons operate more safely and accurately.
All patients will receive a low, personalized dose of ICG given by vein 1 hour before surgery. We will evaluate how well the bile ducts show up on the fluorescence images, as well as safety and effectiveness outcomes. This study will provide a practical, patient-tailored solution for improving bile duct visualization in emergency gallbladder surgery.
- Conditions
- Acute Cholecystitis
- Being tested
- Indocyanine Green (ICG) Fluorescence Cholangiography
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (ICG) Fluorescence CholangiographyDrug
Indocyanine green (ICG) is administered intravenously 1 hour before emergency laparoscopic cholecystectomy. The dose is individualized based on preoperative MRI-measured common bile duct wall thickness using the formula: 0.012 + 0.0035625 × wall thickness (mg/kg). Near-infrared fluorescence cholangiography is performed intraoperatively to visualize the biliary anatomy.
| Study group | Role | What they receive |
|---|---|---|
| Individualized ICG Fluorescence Cholangiography Arm | Experimental | All patients with moderate to severe acute cholecystitis undergoing emergency laparoscopic cholecystectomy receive an individualized, low-dose indocyanine green (ICG) injection. The ICG dose is calculated using a formula based on preoperative MRI-measured common bile duct wall thickness (0.012 + 0.0035625 × wall thickness, mg/kg), administered intravenously 1 hour before surgery. Near-infrared fluorescence cholangiography is performed during surgery to visualize the biliary anatomy. Receives: Drug: Indocyanine Green (ICG) Fluorescence Cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Biliary Tract Visualization Quality Score
Intraoperative assessment of biliary tract visualization quality using a 4-point subjective scale (1=poor, 2=fair, 3=good, 4=excellent). The score is assigned by the operating surgeon based on the clarity of the cystic duct and common bile duct fluorescence signals, with a primary endpoint of achieving a mean score of ≥3.0 across all enrolled patients.
Measured: Intraoperatively (during emergency laparoscopic cholecystectomy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start8 Jan 2025
- Primary completion20 Apr 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibin Wang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551388
- Sponsor's protocol ID
- I-25PJ0054
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li T, Lin C, Wang W. Global, regional, and national burden of pancreatic cancer from 1990 to 2021, its attributable risk factors, and projections to 2050: a systematic analysis of the global burden of disease study 2021. BMC Cancer. 2025 Feb 3;25(1):189. doi: 10.1186/s12885-025-13597-z.
PubMed 39901108Li T, Zhao Y, Dong L, Han J, Zhao B, Lin C, Wang W. Preoperative Iron Isomaltoside administration enhances postoperative anemia recovery in robotic pancreatic surgery. J Robot Surg. 2026 Feb 7;20(1):227. doi: 10.1007/s11701-026-03176-0.
PubMed 41653278
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Weight-Based Indocyanine Green Dosage for Fluorescent Cholangiography in Laparoscopic Cholecystectomy Among Chinese Population：Construction and Validation
- ClinicalTrials.gov ID
- NCT07551388
- Acronym / sponsor ID
- I-25PJ0054
- Conditions
- Acute Cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 24 Apr 2026 (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.
This is a single-center prospective study designed to develop and validate an individualized, low-dose indocyanine green (ICG) protocol for near-infrared fluorescence cholangiography during emergency laparoscopic cholecystectomy in patients with moderate to severe acute cholecystitis.
The main problem we aim to solve is that inflammation in the bile duct wall often makes standard ICG doses ineffective for clear visualization. We will use pre-operative MRI to measure the thickness of the common bile duct (CBD) wall, then calculate a personalized ICG dose using a simple formula. We will first test and refine this formula in a small group of patients, then verify its effectiveness in a second group. The goal is to achieve clear, high-contrast imaging of the bile ducts, which helps surgeons operate more safely and accurately.
All patients will receive a low, personalized dose of ICG given by vein 1 hour before surgery. We will evaluate how well the bile ducts show up on the fluorescence images, as well as safety and effectiveness outcomes. This study will provide a practical, patient-tailored solution for improving bile duct visualization in emergency gallbladder surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized ICG Fluorescence Cholangiography Arm | Experimental | Drug: Indocyanine Green (ICG) Fluorescence CholangiographyAll patients with moderate to severe acute cholecystitis undergoing emergency laparoscopic cholecystectomy receive an individualized, low-dose indocyanine green (ICG) injection. The ICG dose is calculated using a formula based on preoperative MRI-measured common bile duct wall thickness (0.012 + 0.0035625 × wall thickness, mg/kg), administered intravenously 1 hour before surgery. Near-infrared fluorescence cholangiography is performed during surgery to visualize the biliary anatomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years undergoing emergency laparoscopic cholecystectomy.
- Diagnosis of moderate to severe acute cholecystitis according to the 2018 Tokyo Guidelines.
- Preoperative MRI available for common bile duct wall thickness measurement.
- Ability to provide informed consent.
Key exclusion criteria (5 listed)
- Known allergy or contraindication to indocyanine green (ICG).
- Severe renal or hepatic dysfunction (eGFR <30 mL/min/1.73m² or Child-Pugh class B/C cirrhosis).
- Pregnancy or breastfeeding.
- Previous biliary surgery or known choledocholithiasis requiring preoperative intervention.
- Unstable hemodynamic status requiring conversion to open surgery before ICG administration.
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 |
|---|---|---|
| Indocyanine Green (ICG) Fluorescence CholangiographyIndocyanine green (ICG) is administered intravenously 1 hour before emergency laparoscopic cholecystectomy. The dose is individualized based on preoperative MRI-measured common bile duct wall thickness using the formula: 0.012 + 0.0035625 × wall thickness (mg/kg). Near-infrared fluorescence cholangiography is performed intraoperatively to visualize the biliary anatomy. | Drug | Individualized ICG Fluorescence Cholangiography Arm |
Primary outcome
Subjective Biliary Tract Visualization Quality Score
Time frame: Intraoperatively (during emergency laparoscopic cholecystectomy)
Intraoperative assessment of biliary tract visualization quality using a 4-point subjective scale (1=poor, 2=fair, 3=good, 4=excellent). The score is assigned by the operating surgeon based on the clarity of the cystic duct and common bile duct fluorescence signals, with a primary endpoint of achieving a mean score of ≥3.0 across all enrolled patients.
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 24 Apr 2026.
- Background: PubMed 39901108Li T, Lin C, Wang W. Global, regional, and national burden of pancreatic cancer from 1990 to 2021, its attributable risk factors, and projections to 2050: a systematic analysis of the global burden of disease study 2021. BMC Cancer. 2025 Feb 3;25(1):189. doi: 10.1186/s12885-025-13597-z.
- Background: PubMed 41653278Li T, Zhao Y, Dong L, Han J, Zhao B, Lin C, Wang W. Preoperative Iron Isomaltoside administration enhances postoperative anemia recovery in robotic pancreatic surgery. J Robot Surg. 2026 Feb 7;20(1):227. doi: 10.1007/s11701-026-03176-0.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green (ICG) Fluorescence Cholangiography in people with Acute Cholecystitis, run by Peking Union Medical College Hospital at 1 site in China.
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 4 inclusion and 5 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 24 Apr 2026. 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 China. 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?
Subjective Biliary Tract Visualization Quality Score (time frame: Intraoperatively (during emergency laparoscopic cholecystectomy)). 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 NCT07551388, which also lists 2 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 24 Apr 2026.